July/August 2014

Transcription

July/August 2014

July/August 2014
Drug Information Update
Copyright© PerformRx, LLC 2013 All Rights Reserved
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DRUG INFORMATION UPDATE
Table of Contents
NEW GENERICS TO MARKET ................................................................................................................ 3
NEW DRUG ENTITIES ............................................................................................................................ 4
NEW INDICATIONS (EXISTING DRUGS) ................................................................................................ 8
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ...................................................................... 10
STUDIES ............................................................................................................................................... 20
RECALLS ............................................................................................................................................... 45
CURRENT DRUG SHORTAGES ............................................................................................................. 86
NEW DRUGS COMING TO MARKET .................................................................................................191
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NEW GENERICS TO MARKET
GENERIC DRUG NAME
Testosterone
Methoxsalen
Urea
Prenatal Vit #86/Fe, FA, Choline,
DHA, Ca
Valsartan
PNV with Ca, No.70/Iron/FA/DHA
Levomefolate/Algal Oil
B3/Azel/Quer/Tur/FA/B6/Zn/Cop
p
Topiramate
Fenoprofen Calcium
Ropivacaine HCl
Ropivacaine HCl (PF)
Amoxicillin
STRENGTH &
DOSAGE FORM
1.25gm (1%) gel
pump
50mg (1%)
gel packet
10mg cap
35% foam
32mg-1mg tab
GENERIC
MANUFACTURER
Upsher Smith
BRAND NAME
APPROVAL DATE
Vogelxo
06/17/14
Strides
Acella
Prugen
Oxsoralen-Ultra
Hydro 35
Nestabs
06/24/14
05/12/10
06/20/14
40mg, 80mg, 160mg,
320mg tabs
28-1-250mg cap
15-90.314, 7.590.314mg
700-500mg
Sandoz
Diovan
07/08/14
Virtus
Zerxis
Natelle One
Deplin-Algal Oil
07/10/14
03/13/13
Virtus
NicAzel Forte
07/10/14
25mg, 50mg, 100mg,
150mg, 200mg ER
cap
400mg cap
10mg/mL vial
5mg/mL vial (PF)
775mg ER tab
Upsher Smith
Qudexy XR
07/09/14
KLE 2, Inc.
Sandoz
Nalfon
Naropin
07/17/14
07/24/14
Perrigo
Moxatag
08/12/14
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NEW DRUG ENTITIES
DESCRIPTION
PEDIATRIC VITAMIN
PREPARATIONS
PEDIATRIC VITAMIN
PREPARATIONS
BRAND NAME
COMPLETE
FORMULATION
PEDIATRIC
COMPLETE
FORMULATION D3000
GENERIC NAME
STRENGTH
NOTES
PEDI MULTIVIT #77/VIT D3/VIT K
750-500/.5
New
Combination
PEDIATRIC VITAMIN
PREPARATIONS
ESCAVITE D
PEDI MULTIVIT
#78/IRON/FLUORID
6MG-0.25MG
New
Combination
New
Combination
LIPOGLYCOPEPTIDE
ANTIBIOTIC
DALVANCE
DALBAVANCIN HCL
500 MG
New Entity
DIETARY SUPPLEMENT,
MISCELLANEOUS
APPTRIM
CAFF/CHOLINE/AA
COMB.NO7/HC125
40.5-101MG
New
Combination
DIETARY SUPPLEMENT,
MISCELLANEOUS
THERAMINE PLUS
CHOL/AA10/GABA/HERB129/PR
T/LEC
62.5-100-9
New
Combination
CYCLOPHOSPHAMIDE
25 MG
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
50 MG
SUTENT
SUNITINIB MALATE
37.5 MG
New Strength
TEDIZOLID PHOSPHATE
200 MG (IV)
New Entity
TEDIZOLID PHOSPHATE
200 MG (PO)
ANTINEOPLASTIC –
ALKYLATING AGENTS
ANTINEOPLASTIC –
ALKYLATING AGENTS
ANTINEOPLASTIC –
SYSTEMIC ENZYME
INHIBITORS
CYCLOPHOSPHAMIDE
OXAZOLIDINONES
SIVEXTRO
OXAZOLIDINONES
SIVEXTRO
ANTIVIRALS, HIV-1
INTEGRASE STRAND
TRANSFER INHIBITOR
DIETARY SUPPLEMENT,
MISCELLANEOUS
PRENATAL VITAMIN
PREPARATIONS
PRENATAL VITAMIN
PREPARATIONS
ISENTRESS
APPTRIM-D
PRENATE STAR
PRENATE DHA
ACNE AGENTS, TOPICAL
NEUAC
PLASMA PROTEINS
ATRYN
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
NUTRITIONAL THERAPY,
MED COND SPECIAL
PEDI MULTIVIT #61/VIT D3/VIT K
RALTEGRAVIR POTASSIUM
CHOLINE BIT/AA
COMB.NO7/HC125
PRENATAL NO.77/IRON ASP
GLY/FA
PNV #78/IRON ASP
GLY/FA#1/DHA
CLINDAMYCIN/BENZOYL/EMOL
CMB94
ANTITHROMBIN III, HUMAN
RECOMB
FLUCELVAX 2014-2015
FLU VACC TS 14-15 (18+)CELL/PF
FLUZONE HIGH-DOSE
2014-2015
FLU VACC TS 2014-15
(65YR+)/PF
NUTRITIONAL TX,
KETOGENIC/LCT
CARBZERO
3000-800
100 MG
101 MG
20 MG-1 MG
18-1-300MG
1.2(1)%-5%
New Dosage
Form
New Dosage
Form
New Entity
New Dosage
Form
New
Combination
New
Combination
New
Combination
New
Combination
525 UNIT
New Strength
45MCG/.5ML
New Entity
180MCG/0.5
New Entity
20 G-180
New
Combination and
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DESCRIPTION
FORMULATION
NUTRITIONAL THERAPY,
MED COND SPECIAL
FORMULATION
PRENATAL VITAMIN
PREPARATIONS
VITAMIN B12
PREPARATIONS
ANTISEBORRHEIC
AGENTS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
TOPICAL LOCAL
ANESTHETICS
TOPICAL ANTIINFLAMMATORY
STEROIDAL
TOPICAL ANTIBIOTIC &
ANTI-INFLAMMATORY
STEROID
TOPICAL ANTIBIOTIC &
ANTI-INFLAMMATORY
STEROID
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
BRAND NAME
GENERIC NAME
STRENGTH
NOTES
NASCOBAL
PRENATAL #79/IRON ASP
GLY/FA#1
CYANOCOBALAMIN (VITAMIN B12)
500MCG/SPR
Dosage Form
New
Combination and
Dosage Form
New Delivery
Device
New Dosage
Form
OVACE PLUS
SULFACETAMIDE SODIUM
9.80%
New Entity
250 UNIT
New Entity
500 UNIT
New Entity
750 UNIT
New Entity
1000 UNIT
New Entity
1500 UNIT
New Entity
2000 UNIT
New Entity
BETAQUIK
PRENATE ELITE
ELOCTATE
ELOCTATE
ELOCTATE
ELOCTATE
ELOCTATE
ELOCTATE
ELOCTATE
VEXA
NUTRITIONAL TX,
KETOGENIC/MCT
FACTOR VIII REC,FC FUSION
PROT
PROT
PROT
PROT
PROT
PROT
PROT
LIDOCAINE/ALLANTOIN/PETROL
ATUM
21 G-189
20 MG-1 MG
3000 UNIT
New Entity
4%-2%-30 %
New
Combination
CLODAN
CLOBETASOL/SKIN CLEANSER
#28
0.05%
New
Combination
NEO-SYNALAR
NEOMYCIN/FLUOCINOLONE/EM
OL #65
0.5-0.025%
New
Combination
NEO-SYNALAR
NEOMYCIN
SULFATE/FLUOCINOLONE
0.5-0.025%
New
Combination
FLU VACC TS 2014 (1864YRS)/PF
FLU VACCINE QS 201415(6MOS+)
FLU VACC QS 201415(36MOS+)/PF
FLU VACC QS 201415(36MOS+)/PF
FLU VACC TS 201415(36MOS+)/PF
FLU VACCINE TS201415(4YR+)/PF
FLU VACCINE TS 2014-15 (4 YR+)
27MCG/.1ML
(SYR)
60MCG/.5ML
(VIAL)
60MCG/.5ML
(SYR)
60MCG/.5ML
(VIAL)
45MCG/.5ML
(SYR)
45MCG/.5ML
(SYR)
45MCG/.5ML
FLUZONE INTRADERMAL
2014-2015
FLUZONE QUAD 20142015
FLUZONE 2014-2015
FLUVIRIN 2014-2015
FLUVIRIN 2014-2015
New Entity
New Entity
New Entity
New Entity
New Entity
New Entity
New Entity
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DESCRIPTION
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
ANTIHYPERGLY,INCRETI
N MIMETIC(GLP-1
RECEP.AGONIST)
PRENATAL VITAMIN
PREPARATIONS
ANTIDIARRHEAL
MICROORGANISMS
AGENTS
ANTINEOPLAST,HISTON
E DEACETYLASE (HDAC)
INHIBITORS
BRAND NAME
GENERIC NAME
STRENGTH
FLUZONE QUAD PEDI
2014-2015
FLUMIST QUAD 20142015
FLU VACCINE TS 2014-15(6
MOS+)
FLU VACCINE 2014(635MOS)/PF
FLU VACC QV LIVE 2014(249YRS)
(VIAL)
45MCG/.5ML
(VIAL)
30MCG/0.25
(SYR)
10E6.5-7.5 (NAS
SP SYR)
BYDUREON PEN
EXENATIDE MICROSPHERES
2MG/0.65ML
New Strength
and Dosage Form
FOLET ONE
PNV NO.80/IRON/
MFOLATE/DSS/DHA
38-1-25 MG
New
Combination
RESTORA RX
LACTOBACILLUS CASEI/FOLIC
ACID
60-1.25 MG
New
Combination
BELEODAQ
BELINOSTAT
500 MG
New Entity
0.033 %
New Entity
FLUZONE 2014-2015
SODIUM
CHLOR/HYPOCHLOROUS ACID
IRON/MFOLATE/B12/C/BIOT/ZN
/DSS
NOTES
New Entity
New Entity
New Entity
IRRIGANTS
VASHE WOUND THERAPY
IRON REPLACEMENT
MAXFE
KERATOLYTICS
UREA
UREA
40 %
BUNAVAIL
BUPRENORPHINE
HCL/NALOXONE HCL
2.1-0.3 MG
New Strength
and Route
BUNAVAIL
BUPRENORPHINE
HCL/NALOXONE HCL
4.2-0.7 MG
New Strength
and Route
BUNAVAIL
BUPRENORPHINE
HCL/NALOXONE HCL
6.3MG-1MG
New Strength
and Route
JARDIANCE
EMPAGLIFLOZIN
10 MG
New Entity
JARDIANCE
EMPAGLIFLOZIN
25 MG
New Entity
QUFLORA
PEDI MV NO.83 WITH FLUORIDE
0.25 MG/ML
QUFLORA
PEDI MV NO.83 WITH FLUORIDE
0.5 MG/ML
NARCOTIC
WITHDRAWAL THERAPY
AGENTS
NARCOTIC
WITHDRAWAL THERAPY
AGENTS
NARCOTIC
WITHDRAWAL THERAPY
AGENTS
ANTIHYPERGLYCEMCSOD/GLUC
COTRANSPORT2(SGLT2)
INHIB
ANTIHYPERGLYCEMCSOD/GLUC
COTRANSPORT2(SGLT2)
INHIB
PEDIATRIC VITAMIN
PREPARATIONS
PEDIATRIC VITAMIN
PREPARATIONS
SKIN TISSUE
REPLACEMENT
SKIN TISSUE
REPLACEMENT
GRAFIX CORE
GRAFIX PRIME
HUMAN REGENERATIVE TISSUE
MTRX
HUMAN REGENERATIVE TISSUE
MTRX
160MG-1-60
New
Combination
New Formulation
LOTION (GM)
New
Combination
New
Combination
1.5CMX2CM
New Strength
3 CMX 4 CM
New Strength
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DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
TETRACYCLINES
ACTICLATE
DOXYCYCLINE HYCLATE
75 MG
TETRACYCLINES
ACTICLATE
DOXYCYCLINE HYCLATE
150 MG
AFLURIA 2014-2015
FLU VACCINE TS 2014-15 (5 YR+)
AFLURIA 2014-2015
FLU VACCINE TS201415(5YR+)/PF
45MCG/.5ML
ZINC GLUCONATE
ZINC GLUCONATE
1 MG/ML
New Strength,
Route and
Dosage Form
INVOKAMET
CANAGLIFLOZIN/METFORMIN
HCL
50-1000 MG
New
Combination
INVOKAMET
HCL
150-1000MG
New
Combination
INVOKAMET
HCL
150-500MG
New
Combination
INVOKAMET
HCL
50MG-500MG
New
Combination
CITRANATAL RX
PNV NO.81/IRON
CBN&GLUC/FA/DSS
27-1-50 MG
New
Combination
NORTHERA
DROXIDOPA
100 MG
New Entity
NORTHERA
DROXIDOPA
200 MG
New Entity
NORTHERA
DROXIDOPA
300 MG
New Entity
APOP
SULFACETAMIDE
SODIUM/BAKUCHIOL
10%-0.5%
New
Combination
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
ZINC REPLACEMENT
ANTIHYPERGLYCEMICSGLT2 INHIBITOR &
BIGUANIDE COMB
BIGUANIDE COMB
BIGUANIDE COMB
BIGUANIDE COMB
PRENATAL VITAMIN
PREPARATIONS
ADRENERGIC
VASOPRESSOR AGENTS
ADRENERGIC
VASOPRESSOR AGENTS
ADRENERGIC
VASOPRESSOR AGENTS
ACNE AGENTS,TOPICAL
45MCG/.5ML
NOTES
New Dosage
Form
New Dosage
Form
New Entity
New Entity
7
NEW INDICATIONS (EXISTING DRUGS)
NOVOSEVEN®
July 7, 2014
FDA Approves NovoSeven® RT for the Treatment of Glanzmann's Thrombasthenia (GT) With
Refractoriness
First Recombinant Treatment Approved in US for Patients With GT With Refractoriness to
Platelet Transfusions, With or Without Antibodies to Platelets
PLAINSBORO, N.J., July 7, 2014 /PRNewswire/ -- Novo Nordisk today announced the US
Food and Drug Administration (FDA) has approved NovoSeven® RT (Coagulation Factor VIIa
[Recombinant]) as the first recombinant treatment for bleeding episodes and perioperative
management in patients with Glanzmann's Thrombasthenia (GT) with refractoriness to
platelet transfusions, with or without antibodies to platelets. Glanzmann's Thrombasthenia is
a rare genetic bleeding disorder with limited treatment options. The safety and effectiveness
of NovoSeven® RT were demonstrated in the treatment of severe bleeding episodes and the
perioperative management for major and minor surgical procedures for this specific patient
population.
Article link:http://press.novonordisk-us.com/2014-07-07-FDA-Approves-NovoSeven-RT-fortheTreatment-of-Glanzmanns-Thrombasthenia-GT-With-Refractoriness
Source website:http://press.novonordisk-us.com/
IMBRUVICA®
July 28, 2014
U.S. FDA Grants Regular (Full) Approval for IMBRUVICA® for Two Indications
Jul 28, 2014
Previously Treated Chronic Lymphocytic Leukemia (CLL) Based on Statistically
Significant Progression-Free and Overall Survival Benefits
Del 17P CLL, Only FDA-Approved Agent
Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the U.S. Food and Drug
Administration (FDA) has granted IMBRUVICA® (ibrutinib) regular (full) approval for the
treatment of patients with chronic lymphocytic leukemia (CLL) who have received at
least one prior therapy, and for the treatment of CLL patients with deletion of the short
arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated
del 17p CLL patients.
Article link: http://ir.pharmacyclics.com/releasedetail.cfm?ReleaseID=862371
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Source website:http://ir.pharmacyclics.com/
EYLEA®
July 29, 2014
EYLEA® (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic
Macular Edema (DME)
DME is the third approved indication for EYLEA in the U.S.
TARRYTOWN, N.Y., July 29, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced thatthe U.S. Food and Drug Administration (FDA)
has approved EYLEA® (aflibercept) Injection for the treatment of Diabetic
MacularEdema (DME). The recommended dosage of EYLEA in patients with DME is 2
milligrams (mg) every two months (8 weeks) after five initial monthly injections.
Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy
was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8
weeks.
Article link: http://files.shareholder.com/downloads/REGN/
3365699376x0x772028/698a12f7-a8dc-4f89-b9e2f8134ae6f3de/REGN_News_2014_7_29_General_Releases.pdf
Source website: http://files.shareholder.com/
LUMIZYME®
August 1, 2014
Lumizyme®
Genzyme Receives Label Expansion for Lumizyme® (alglucosidase alfa) in the United States
for the treatment of Pompe Disease
August 1, 2014 - CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company
(EURONEXT: SAN and NYSE: SNY), today announced that the U.S. Food and Drug
Administration (FDA) approved a supplement to expand the indication for Lumizyme®
(alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all
Pompe patients of any age or phenotype. The approval of this indication is now consistent
with that of the rest of the world, where alglucosidase alfa manufactured at the 4000L is the
only scale available. Previously, in the United States, Lumizyme had been approved only for
patients with late onset Pompe disease.
9
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast:
Recall- Labeling Error
June 11, 2014
ISSUE: Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all
BMBBA006A
Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster
Bio-Tech Corp due to a labeling error which could result in confusion about which meter
models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with.
In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is
recalling the test strips in an effort to avoid confusion and the possible misuse of the
Advocate Redi-Code+blood glucose test strips with the Taidoc meters listed in the Firm Press
Release, which could result in incorrect glucose results.
Falsely high or falsely low glucose results could potentially cause missed or delayed
hyperglycemia or hypoglycemia detection and lead to no treatment or inappropriate
treatment. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states
could lead to serious health consequences, including death.
BACKGROUND: Diabetic Supply of Suncoast, Inc. is notifying its wholesale Distributors,
Pharmacies, Medical Supply stores, Health Care Providers and direct customers throughout
the entire US and Virgin Islands by letter and Press Release about the specifics of the recall.
RECOMMENDATION: Customers who have the affected test strips can contact Diabetic
Supply of Suncoast, Inc. directly for further information. Test strips will be replaced with
relabeled boxes of test strips to avoid any chance of confusion. Consumers should stop using
the above mentioned test strips and contact Suncoast to find out if this recall pertains to the
test strips they have in their possession and if so how to have them replaced for the
relabeled products manufactured by BroadMaster Bio-Tech.
Customers with questions may contact Diabetic Supply of Suncoast at (561) 296-0488
between the hours of 9:00AM and 5:00PM Monday through Friday Eastern standard time or
view the information at www.dsosi.com.
Customers who have the Advocate Redi-Code blood glucose meters manufactured by Taidoc
Technology Corp should follow the product User Manual for information about the
appropriate test strips to be used with the Taidoc meters.
Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm400668.htm
Source website: http://www.fda.gov/
10
Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol
Intoxication
June 20, 2014
ISSUE: FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol,
also known as alcohol, which may cause patients to experience intoxication or feel drunk
during and after treatment. FDA is revising the labels of all docetaxel drug products to warn
about this risk.
BACKGROUND: Docetaxel is a prescription chemotherapy drug used to treat different kinds
of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and
non-small-cell lung cancer.
RECOMMENDATION: Health care professionals should consider the alcohol content of
docetaxel when prescribing or administering the drug to patients, particularly in those whom
alcohol intake should be avoided or minimized and when using it in conjunction with other
medications.
Healthcare professionals and patients are encouraged to report adverse events or side
effects related to the use of these products to the FDA's MedWatch Safety Information and
Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
•Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
06/20/2014
ISSUE: FDA notified health professionals and their medical care organizations that it is
requiring the manufacturers of all approved testosterone products to include a warning in
the drug labeling about the risk of blood clots in the veins, also known as venous
thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism
(PE).
BACKGROUND: The risk of venous blood clots as a possible consequence of polycythemia is
already included in the labeling of testosterone products. Because there have been
postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a
change to drug labeling of all testosterone products to provide a more general warning
regarding venous blood clots, to ensure this risk is described consistently in the labeling of
all approved testosterone products.
11
RECOMMENDATION: Note - This new warning, a class labeling change, is not related to an
ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients
taking testosterone products. FDA is currently evaluating the potential risk of these
cardiovascular events, which are related to blood clots in the arteries and are described in a
January 31, 2014 MedWatch Safety Alert.
Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should
Not Be Used to Treat Teething Pain
June 26, 2014
ISSUE: FDA notified health professionals, their provider organizations and caregivers for
infants, that prescription oral viscous lidocaine 2% solution should not be used to treat
infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the
prescribing information (label) to highlight this information. Oral viscous lidocaine solution is
not approved to treat teething pain, and use in infants and young children can cause serious
harm, including death.
Topical pain relievers and medications that are rubbed on the gums are not necessary or
even useful because they wash out of the baby’s mouth within minutes. When too much
viscous lidocaine is given to infants and young children or they accidentally swallow too
much, it can result in seizures, severe brain injury, and problems with the heart. Cases of
overdose due to wrong dosing or accidental ingestion have resulted in infants and children
being hospitalized or dying.
BACKGROUND: In 2014, FDA reviewed 22 case reports of serious adverse reactions,
including deaths, in infants and young children 5 months to 3.5 years of age who were given
oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething
and stomatitis, or who had accidental ingestions. See further details in the FDA Drug Safety
Communication.
RECOMMENDATION: Health care professionals should not prescribe or recommend this
product for teething pain. Parents and caregivers should follow the American Academy of
Pediatrics’ recommendations for treating teething pain.
• Use a teething ring chilled in the refrigerator (not frozen).
• Gently rub or massage the child’s gums with your finger to relieve the symptoms.
FDA is also encouraging parents and caregivers not to use topical medications for teething
pain that are available over the counter (OTC) because some of them can be harmful. FDA
recommends following the American Academy of Pediatrics’ recommendations to help lessen
teething pain.
12
Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs"
Label: Warning - Products Not FDA Approved
June 30, 2014
ISSUE: FDA alerted health care professionals not to use injectable vitamin drug products
distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the
label. These products are manufactured by Compound Brothers Dominicana (also known as
CB Inc.) in the Dominican Republic and sold as prescription injectable nutritional
supplements. FDA has not approved these products and cannot be assured of their safety,
effectiveness, or quality.
All lots of non-expired products from Compound Brothers Inc. and labeled as Sunshine Labs
are being recalled by Medical Supply Liquidators. See the FDA Statement for a listing of all
affected products.
RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse
events or side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
FDA outlines expectations for human drug compounders, including registered
outsourcing facilities
July 1, 2014
Today, the U.S. Food and Drug Administration issued several policy documents regarding
compounded drug products for human use, as part of the agency’s continuing effort to
implement the compounding provisions of the Drug Quality and Security Act (DQSA),
enacted in November 2013. The policy documents consist of a draft interim guidance, a
proposed rule, a final guidance, and two revised requests for nominations for the bulk drug
substances lists.
Article link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm403507.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
13
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible
Containers: Recall (One Lot) - Mold Contamination
July 11, 2014
ISSUE: Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of
one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container,
NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015 . This action is due to one confirmed
customer report where particulate was identified within the solution of the primary container.
The particulate was identified as a filamentous-like structured particulate indicative of mold.
Analysis of the primary container and overwrap indicated a puncture in the same physical
location, causing the primary container to leak.
Intravenous administration of a non-sterile product can result in infections that may be
life-threatening, and may result in prolonged hospitalization or organ failure. Hospira has not
received reports of any adverse events associated with this issue for this lot to date, and
has not identified any quality issues with retention samples for this lot.
BACKGROUND: The product is indicated for parenteral replacement of extracellular losses
of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the
clinical condition of the patient. The product is packaged in 1000mL flexible containers, 1
container per overwrap, and 12 overwrapped containers in each case. The lot number is
located in the upper left hand side of the primary container. This lot was distributed
nationwide from December 2013 through February 2014 and was distributed to hospitals,
clinics, wholesalers and distributors.
RECOMMENDATION: Anyone with an existing inventory should stop use and distribution,
quarantine the product immediately, and call Stericycle at 1-888-912-8457 between the
hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product.
14
The MedWatch June 2014 Safety Labeling Changes posting includes 37 products
with safety labeling changes to the following sections: BOXED WARNINGS,
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and
PATIENT PACKAGE INSERT.
July 15, 2014
The "Summary Page" provides a listing of product names and safety labeling sections
revised:
http://www.fda.gov/Safety/MedWatch/ SafetyInformation/ucm402776.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS,
WARNINGS and PRECAUTIONS sections:
Alsuma (sumatriptan)
Androderm (testosterone)
AndroGel (testosterone) gel
Avalide (irbesartan and hydrochlorothiazide)
Aveed (testosterone undecanoate)
Axiron (testosterone)
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil-hydrochlorothiazide)
Caverject (alprostadil for injection)
Caverject Impulse Dual Chamber System (alprostadil for injection)
Cerebyx (Fosphenytoin Sodium Injection)
Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent
dextrose)
Cleocin HCL (clindamycin hydrochloride)
Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate)
Comtan (entacapone)
Delatestryl (testosterone enanthate)
Ella (ulipristal acetate)
Fortesta (testosterone) gel
Gazyva (obinutuzumab)
Herceptin (trastuzumab)
Hycamtin (topotecan)
Jetrea (ocriplasmin)
Lupron Depot (leuprolide acetate)
Nutropin AQ (somatropin [rDNA origin])
Prolia (denosumab)
Ravicti (glycerol phenylbutyrate)
Saizen (somatropin [rDNA origin])
Serostim (somatropin [rDNA origin] for injection)
Sporanox (itraconazole)
15
Striant (testosterone)
Sutent (sunitinib malate)
Symlin (pramlintide acetate)
Testim (testosterone)
Testosterone gel
Tev-Tropin (somatropin [rDNA origin])
Thalomid (thalidomide)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trileptal (oxcarbazepine)
Votrient (pazopanib)
Xgeva (denosumab)
Zestril (lisinopril)
Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm402776.htm
Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall Mislabeled Packaging
07/21/2014
ISSUE: American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration
Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation
that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg,
lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot
#142544, Expiration Date, 02/2016. This recall is the result of mislabeled inner unit
dose blister packaging which could result in patients receiving ibuprofen and missing
their scheduled dose of oxcarbazepine. Failure to receive the proper dose of
oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption
of ibuprofen may cause adverse reactions in a number of patients in which use of
ibuprofen is contraindicated
BACKGROUND: Oxcarbazepine is used for treating certain types of seizures in patients
with epilepsy.
Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP,
600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by
physical description: white, oval-shaped, film-coated tablets, with “IP 465” printed on
one side.
Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets,
300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-14311, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by
physical description: yellow color, capsule shaped, film-coated tablets scored and
debossed with '184' on one side and scored on other side.
16
These hospital unit dose products were distributed nationwide beginning June 20, 2014.
RECOMMENDATION: Notification of the recall has been sent to distributors who received
the affected product with instructions on how to notify their customers.
Consumers who have received the recalled product should immediately discontinue use
and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST
for instructions on returning the recalled product.
For medical information questions or product complaints related to Oxcarbazepine
Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health
Packaging customer service at 1-800-707-4621 from 8am to 4pm EST.
Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible
Particulates
July 30, 2014
ISSUE: Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per
mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD,
Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored
product with visible particles in the solution as well as particulate embedded in the
molded glass container. Hospira has identified the particulate as iron oxide.
Risk factors associated with the particulate include the potential for particulate to be
injected and/or a delay in therapy. If the particulate goes undetected and solution is
administered - depending on the particle size and number - it could block administration
of the drug to the patient, causing a delay in therapy. Particulates may be able to pass
through the catheter and may result in local inflammation, mechanical disruption of
tissue or immune response to the particulate. While extremely rare, particulate exposed
to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue
damage.
BACKGROUND: Lidocaine is packaged 10 units per carton / 180 units per case in singledose
glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers,
hospitals and clinics from June 2013 through July 2013.
RECOMMENDATION: Anyone with existing inventory should immediately stop use and
quarantine any affected product. In addition, customers should inform potential users of
this product in their organizations of this notification. Hospira is notifying its direct
distributors/customers via a recall letter and will arrange for impacted product to be
returned to Stericycle for return processing. For additional assistance, call Stericycle
at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET). For clinical inquiries, refer to the Firm
17
Press Release.
Article link: http://www.fda.gov/Safety/MedWatch/ SafetyInformation/ucm402776.htm
FDA expands approval of drug to treat Pompe disease to patients of all ages;
removes risk mitigation strategy requirements
August 1, 2014
The U.S. Food and Drug Administration today announced the approval of Lumizyme
(alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including
patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation
Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education)
Program is being eliminated.
Pompe disease is a rare genetic disorder and occurs in an estimated 1 in every 40,000 to
300,000 births. Its primary symptom is heart and skeletal muscle weakness, progressing to
respiratory weakness and death from respiratory failure.
The disease causes gene mutations to prevent the body from making enough of the
functional form of an enzyme called acid alpha-glucosidase (GAA). This enzyme is necessary
for proper muscle functioning. GAA is used by the heart and muscle cells to convert a form
of sugar called glycogen into energy. Without the enzyme action, glycogen builds up in the
cells and, ultimately, weakens the heart and muscles. Lumizyme is believed to work by
replacing the deficient GAA, thereby reducing the accumulated glycogen in heart and skeletal
muscle cells.
Source: U.S. Food and Drug Administration (FDA)
CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall Foreign Particulate Matter
08/09/2014
ISSUE: Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin
for injection) to the user level following complaints of foreign particulate matter in
reconstituted vials. Refer to the Press Release for a list of affected products.
The administration of particulate matter, if present in an intravenous drug, poses a potential
safety risk to patients such as a thromboembolism or a life-threatening pulmonary
embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles,
activation of platelets or subsequent generation of microthrombi are also possible. Patients
with a preexisting condition of trauma or other medical condition that adversely affects the
microvascular blood supply are at an increased risk. Administration of a particulate can also
lead to formation of granulomas, which represent a protective local inflammatory response
to the foreign material. To date, no reports of adverse events have been associated with
product complaints of particulate matter from these lots.
18
BACKGROUND: CUBICIN is an intravenously administered prescription product indicated for
the treatment of skin infections and certain blood stream infections. CUBICIN was distributed
Nationwide to multiple consignees.
RECOMMENDATION: Anyone with an existing inventory of the product lots listed should
determine whether they have product from the recalled lots, quarantine, and discontinue
distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between
the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and
replacement of the affected lots.
Source: U.S. Food and Drug Administration (FDA)
19
STUDIES and RECENT TOPICS
Prescription Overdose Deaths in Florida Plunge After Tougher Measures, Report
Says
July 1, 2014
Prescription drug overdose deaths in Florida fell sharply after the state began strengthening
its prescribing laws and stepping up enforcement. Federal researchers said Tuesday that it
was the first significant documented decline in the nation since the epidemic of prescription
drug abuse took hold more than a decade ago.
Article link: http://www.nytimes.com/2014/07/02/health/prescription-drug-deaths-infloridaplungeafter-tougher-laws.html?partner=rss&emc=rss&_r=1
Source website: http://www.nytimes.com/
Painkiller prescription rates vary widely among states
July 1, 2014
U.S. health care providers wrote 259 million prescriptions for opioid painkillers in 2012,
enough to give a bottle of the pills to every adult in the country. But your chances of ending
up with those pills – and the risks that come with them – depend a lot on where you live,
says a new report from the federal Centers for Disease Control and Prevention.
Article link: http://www.usatoday.com/story/news/nation/2014/07/01/painkillerprescriptionratesstates/11898327/
Source website: http://www.usatoday.com/
FDA tightens oversight of pharmacies
July 1, 2014
The Food and Drug Administration is beefing up its oversight of pharmacies that create
custom drugs in response to a 2012 meningitis outbreak linked to tainted medicines that left
64 people dead.
The FDA released regulations Tuesday for compounding pharmacies, which work with
physicians to create specific drugs for individual patients, rather than mass producing
pharmaceuticals for the public.
Article link: http://thehill.com/policy/healthcare/211060-fda-tightens-oversight-of-pharmacies
Source website: http://thehill.com/
20
Roche to Cochrane: Critical Tamiflu study made 'fundamental mistakes'
July 1, 2014
Back in April, a study conducted by the nonprofit Cochrane Group suggested that the $2
billion worth of Roche's ($RHHBY) Tamiflu and other flu fighters stockpiled by the U.S. and
the U.K. to protect against a pandemic has essentially amounted to money thrown down the
drain. Now Roche is fighting back, claiming the Cochrane researchers, whose paper was
published in the British Medical Journal, failed to include all the relevant data, and
furthermore didn't seem to understand how Tamiflu works. The BMJ recently posted Roche's
response to the study on its website.
Article link: http://www.fiercepharma.com/story/roche-cochrane-critical-tamiflu-studymadefundamentalmistakes/2014-07-01
Source website: http://www.fiercepharma.com/
What’s in a Name? FDA Urged Not to Give Biosimilars Unique Names.
July 2, 2014
When a biosimilar version of the Avastin cancer treatment becomes available, what should it
be called?
The chemical name is bevacizumab, and this is often used by physicians and pharmacists
when they discuss the drug. But whether such generic nomenclatures should also become
widely used commercial monikers is the subject of an ongoing controversy among drug
makers and their major customers.
Article link:http://blogs.wsj.com/pharmalot/2014/07/02/whats-in-a-name-fda-urged-nottogivebiosimilars-unique-names/
Source website: http://blogs.wsj.com/
Sitagliptin Linked to Higher HF Hospitalization Risk
July 2, 2014
In patients with type 2 diabetes and heart failure, the use of sitagliptin (Januvia) was
associated with greater risk of hospitalization for heart failure, a study based on insurance
claims showed.
Article link: http://www.medpagetoday.com/Cardiology/Diabetes/46602
Source website: http://www.medpagetoday.com/
21
Testosterone therapy showed no increased risk for MI in older men
July 2, 2014
A national sample of men older than 65 years showed no increased risk for myocardial
infarction in those who were prescribed testosterone therapy as compared with nonusers,
according to study data published today.
Article link: http://www.healio.com/endocrinology/hormonetherapy/
news/online/%7B35b2c02e-571a-4758-b307-401b0965065c%7D/testosteronetherapyshowed-no-increased-risk-for-mi-in-older-men
Source website: http://www.healio.com/
Roche biotech drug offers new way to fight asthma
July 2, 2014
An experimental antibody drug from Roche has produced promising results in mid-stage
tests for asthma, offering a new way to fight the breathing disorder.
The encouraging response seen with quilizumab, which the Swiss group is developing as a
treatment for moderate-to-severe asthma, underscores the growing focus on novel biotech
medicines for hard-to-treat cases of the disease.
Article link: http://www.reuters.com/article/2014/07/02/rocheasthmaidUSL6N0PD3V520140702
Source website: http://www.reuters.com/
FDA's Looming Decision On A Generic To Teva's Copaxone Reveals Drug Approval
Woes
July 7, 2014
A year ago, the Food and Drug Administration quietly posted a public notice that it wanted
to hire an independent lab to test a generic drug that it had already approved. FDA wanted
to make sure the drug was safe and effective.
Article link: http://www.forbes.com/sites/scottgottlieb/2014/07/07/fdas-looming-decisionongenericcopaxone-from-teva-reveals-drug-approval-woes/?ss=pharma
Source website: http://www.forbes.com/
Novartis cell treatment named "Breakthrough Therapy" in US
July 7 2014
Swiss drugmaker Novartis said on Monday U.S. health regulators have granted its
personalised cell therapy CLT019 "Breakthrough Therapy" status, meaning the treatment will
be fast-tracked within the U.S. regulatory system.
Article link: http://in.reuters.com/article/2014/07/07/novartis-drug-idINL6N0PI4W720140707
Source website: http://in.reuters.com/
22
BioDelivery, Endo painkiller moves one step closer to approval
July 7 2014
Endo International Plc and BioDelivery Sciences International Inc said their experimental
pain drug was found effective in a second late-stage trial, taking the drug a step closer to a
marketing approval.
BioDelivery's shares jumped as much as 20 percent to a new life-high, while Endo was down
1.7 percent on Monday morning.
Article link: http://www.reuters.com/article/2014/07/07/endo-intlstudyidUSL4N0PI2XU20140707
Obesity May Raise Risk of COPD
July 7, 2014
Obese people, particularly those with excess belly fat, may face a higher risk of developing
chronic obstructive pulmonary disease (COPD), a new study suggests.The researchers report
that women with a waist size of roughly 43 inches or more and men with waist size of 46
inches or more showed a 72 percent increased risk of developing the lung disease, compared
with people who had a normal waist size.
Article link: http://consumer.healthday.com/vitamins-and-nutrition-information27/obesityhealthnews-505/obesity-linked-with-copd-risk-689538.html
Source website: http://consumer.healthday.com/
Scientists Are Getting Closer to a Blood Test for Alzheimer’s
July 8, 2014
A team of scientists have identified 10 proteins in the blood that can predict the onset of
Alzheimer’s disease. The study, which was published in the journal Alzheimer’s & Dementia,
looked at more than 1,000 people and is considered a significant step toward the
development of a blood test for Alzheimer’s. The trouble with the disease is that developing
drug treatments is difficult since they are often given in clinical trials when the disease has
already progressed too far. The hope is that identifying the disease earlier could pave the
way for drugs to halt its progression.
Article link: http://time.com/2963692/alzheimers-disease-blood-test/
Source website: http://time.com/
Sanofi's (SNY) NDA for Toujeo Accepted for Review by U.S. FDA
July 8, 2014
Sanofi (NYSE: SNY) said that the U.S. Food and Drug Administration (FDA) has accepted for
review the company's New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin]
23
injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the
acceptance of the marketing authorization dossier for Toujeo by the European Medicines
Agency (EMA) for EU countries on May 27, 2014.
Article link: http://www.streetinsider.com/Corporate+News/Sanofis+(SNY)+NDA+for+
Toujeo+Accepted+for+Review+by+U.S.+FDA/9643953.html
Source website: http://www.streetinsider.com/
Rapid Price Increases for Some Generic Drugs Catch Users by Surprise
July 8, 2014
The first sign of trouble came when Dr. Barry Lindenberg, a cardiologist, received a threepage
insurance form in January, demanding he get preapproval to prescribe one of the
oldest known heart medicines.
His patient had been on the drug, digoxin, for many years. A mainstay of treating older
patients with rapid rhythm disturbances, it was first described in the medical literature in
1785. Millions of Americans still use it every day, and many had long paid just pennies a pill.
Article link: http://www.nytimes.com/2014/07/09/health /some-generic-drug-pricesaresoaring.
html?hp&action=click&pgtype=Homepage&version= HpSumSmal
lMediaHigh&module=second-column-region&region=top-news&WT.nav=top-news&_r=0
Study: Psych drug ER trips approach 90,000 a year
July 9, 2014
Bad reactions to psychiatric drugs result in nearly 90,000 emergency room visits each year
by U.S. adults, with anti-anxiety medicines and sedatives among the most common culprits,
a study suggests.
A drug used in some popular sleeping pills was among the most commonly involved
sedatives, especially in adults aged 65 and older.
Article link: http://hosted.ap.org/dynamic/stories/U/US_MED_PSYCH_DRUG_EMERGENCIES?
SITE= AP&SECTION=HOME&TEMPLATE=DEFAULT
Source website: http://hosted.ap.org/
FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules
July 9, 2014
Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug
approved to treat seizures and prevent migraine headaches, might also help combat alcohol
dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders
or insomnia? Or offer data showing that any number of other drugs could have uses beyond
those listed on their labels?
24
Article link: http://www.washingtonpost.com/national/healthscience/2014/07/09/3708dd6afbc411e3-8176-f2c941cf35f1_story.html
Source website: http://www.washingtonpost.com/
Sanofi Plans Final Tests as Regeneron Drug Cuts Eczema Symptoms
July 9, 2014
Sanofi (SAN) and Regeneron Pharmaceuticals (REGN) said they plan to test their
experimental eczema treatment in large late-stage studies after a smaller trial reduced
symptoms of the scaly, itching disease.
Article link: http://www.bloomberg.com/news/2014-07-09/sanofi-plans-final-testsasregenerondrug-cuts-eczema-symptoms.html
Source website: http://www.bloomberg.com/
Breast Cancer Drug May Help Women Fight a Leading Cause of Infertility: Study
July 9, 2014
Letrozole improves pregnancy rates in women with polycystic ovary syndrome, researcher
says
Women with polycystic ovary syndrome have a better chance of getting pregnant if they
take a breast cancer drug instead of the currently preferred medication, a new study
suggests.
Article link: http://consumer.healthday.com/diseases-and-conditions-information37/miscdiseasesand-conditions-news-203/breast-cancer-drug-help-fight-common-cause-ofinfertilitystudy-finds-689619.html
FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant
July 10, 2014
A highly promising novel anticoagulant system now appears to be in serious difficulty.
Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient
enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys
anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an
agent, anivamersen, which reverses its anticoagulant effect.
Article link: http://www.forbes.com/sites/larryhusten/2014/07/10/fda-places-clinical-holdonphase3-trial-of-novel-anticoagulant/
25
Study finds alarming global rise in use of antibiotics
July 10, 2014
Antibiotic use has surged by 36% worldwide in a decade, much of it unwarranted, according
to a new study.
The rise, particularly in countries with a burgeoning middle class, heightens concerns that
overuse of antibiotics is leaving more of the world's population vulnerable to drug-resistant
bacteria, according to the authors of the analysis, published online Thursday in the journal
Lancet Infectious Diseases.
Article link: http://www.latimes.com/science/sciencenow/la-sci-sn-global-rise-antibiotics20140710-story.html#
Source website: http://www.latimes.com/
Questcor Reveals Adverse Events Data for Acthar for First Time
July 10, 2014
For years, Questcor Pharmaceuticals has highlighted the potential benefits of Acthar, its
immune-system drug, while saying little about its ill effects.
But according to a regulatory filing made by Questcor early Thursday, the number of
patients reporting a so-called adverse event while using the drug last year represented
almost 5 percent of prescriptions dispensed. The total number of events in 2013 reported by
patients, who can experience multiple ill effects, was almost 14 percent of prescriptions, up
from 9.1 percent in 2011.
Article link: http://www.nytimes.com/2014/07/11/business/questcor-reveals-adverseeventsdatafor-acthar-for-first-time.html?ref=health&_r=0
Insurers balk at pricey generic version of ancient GSK heart drug
July 10, 2014
The heart drug digoxin--a generic version of GlaxoSmithKline's ($GSK) Lanoxin--used to
cost just pennies a pill, making it a prescription that insurance companies were more than
happy to cover. Not anymore. The three companies that make generic digoxin have been
increasing their prices, causing the cost of the drug to nearly double in the last year.
Article link: http://www.fiercepharma.com/story/insurers-balk-pricey-generic-versionancientgskheart-drug/2014-07-10
Source website: http://www.fiercepharma.com/
26
India's Sun Pharma recalls over 40,000 bottles of antidepressant
July 11, 2014
India's Sun Pharmaceutical Industries is recalling 41,127 bottles of antidepressant
venlafaxine hydrochloride in the United States after the drug failed to dissolve properly, the
U.S. Food and Drug Administration said.
Article link: http://health.yahoo.net/news/s/nm/india-s-sun-pharma-recalls-over-40-000bottles-of-antidepressant
Source website: http://health.yahoo.net/
Study calls for more focus on long-term outcomes in pediatric trials of drugs intended for
chronic use like in ADHD
July 11, 2014
Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20
medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that
were not designed to study their long-term efficacy and safety or to detect rare adverse
events, researchers at Boston Children's Hospital report in PLOS ONE. The study highlights
gaps in how the long-term safety of drugs intended for chronic use in children is assessed as
part of the FDA approval process.
Article link: http://www.medicalnewstoday.com/releases/279403.php
Source website: http://www.medicalnewstoday.com/
Is This MannKind's Greatest Risk?
July 11, 2014
Not long ago, some predicted that MannKind (NASDAQ: MNKD ) faced the serious risk of
striking out on winning approval for Afrezza. Instead, those predictions swung and missed.
The U.S. Food and Drug Administration recently approved the inhaled insulin.
Article link: http://www.fool.com/investing/general/2014/07/11/ is-this-mannkindsgreatestrisk.
aspx
Source website: http://www.fool.com/
FDA Once Again Reaches Conclusions At Odds With Its Own Staff
July 14, 2014
Once again the FDA has reached a conclusion that is directly opposed by some of its own
scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure
lowering drug (sold as Benicar and other names). But that reassuring view is not shared by
the FDA scientists who performed the study that provided the basis for the review. And now
outside experts are also raising concerns about the drug.
27
Article link: http://www.forbes.com/sites/larryhusten/2014/07/14/fda-once-againreachesconclusionsat-odds-with-its-own-staff/
Skin gel new ammunition in fight against breast cancer
July 14, 2014
A gel containing the drug tamoxifen and applied to the skin was as effective in reducing the
growth of breast cancer cells in women with noninvasive cancer as the pill form of the
medication — and it caused fewer side effects, according to a new study.
Article link: http://wpost.com/national/health-science/skin-gel-new-ammunition-infightagainstbreast-cancer/2014/07/14/f764fb4c-0b6f-11e4-8341-b8072b1e7348_story.html
Source website: http://wpost.com/
Don't Judge a Pill by Its Color
July 14, 2014
Study finds people may stop taking heart medications if the drug's appearance changes
Generic drugs used for heart disease commonly get makeovers that change their shape or
color -- and that may prompt some patients to stop using them, a new study finds.
Article link:http://consumer.healthday.com/public-health-information-30/drug-safety-news741/when-heart-drugs-change-their-look-people-may-stop-taking-them-689672.html
Source website:http://consumer.healthday.com/
FDA Grants Priority Review to New Hep C Combo
July 15, 2014
Medivir AB announced that the U.S. Food and Drug Administration (FDA) has assigned a
Priority Review designation to the supplemental New Drug Application (sNDA) for the use of
once-daily Olysio (simeprevir), in combination with sofosbuvir, for 12 weeks treatment of
adult patients with genotype 1 chronic hepatitis C. The sNDA was filed in May by Medivir’s
strategic partner Janssen Research & Development LLC.
Article link: http://www.dddmag.com/news/2014/07/fda-grants-priority-review-new-hepccombo?
et_cid=4048933&et_rid=696418053&type=cta
Source website: http://www.dddmag.com/
28
Niacin Doesn't Reduce Heart Problems, May Create Some, Research Finds
July 16, 2014
Niacin, a commonly used cholesterol treatment, doesn't reduce the risk of heart attack or
stroke in people with hardened arteries. What's more, the drug appears to have dangerous
side effects, including a potential increased risk of death, according to new research.
Article link: http://consumer.healthday.com/cardiovascular-health-information-20/miscstrokerelated-heart-news-360/niacin-doesn-t-appear-to-reduce-heart-problems-researchfinds689846.html
Roche Alzheimer's drug fails main goals in mid-stage study
July 16, 2014
Roche's experimental drug crenezumab failed to delay a decline in thinking and memory
skills in people with Alzheimer's disease, a result likely to bolster a growing belief that drugs
need to be given in earlier stages of the disease to show a benefit.
The Swiss drugmaker's treatment was tested in patients with mild-to-moderate forms of
Alzheimer's, a fatal, brain-wasting condition that gradually robs patients of their ability to
think and care for themselves.
Article link: http://www.reuters.com/article/2014/07/16/us-alzheimer-s-rochecrenezumabidUSKBN0FL1Z820140716
5 Groundbreaking Trials Are Testing Ways to Prevent Alzheimer’s
July 16, 2014
Researchers are testing some promising drug candidates to halt Alzheimer’s dementia – even
before symptoms startAt the Alzheimer’s Association International Conference in
Copenhagen, scientists described five trials that taking the unprecedented step of testing
drugs that may prevent the onset of the neurodegenerative disease in people not yet
experiencing cognitive decline.
Article link: http://time.com/2992603/5-groundbreaking-drugs-that-may-prevent-alzheimers/
Source website: http://time.com/
Antibiotics Often Prescribed Needlessly for Terminally Ill, Study Finds
July 16, 2014
Antibiotics are given to many hospice patients, although there's little proof the medicines
benefit them, a new study shows.
About 21 percent of patients who go directly from hospitals to hospice care for the terminally
ill leave the hospital with an antibiotic prescription, even though more than one-quarter
didn't have an infection while in the hospital, the researchers found.
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Article link: http://consumer.healthday.com/infectious-disease-information21/antibioticsnews30/antibiotics-often-prescribed-for-terminally-ill-study-finds-689775.html
AIDS Epidemic May Be Subsiding: Report
July 16, 2014
A new United Nations report suggests that the AIDS epidemic might be waning: The
number of new HIV infections worldwide is at a record low, AIDS-related deaths are
down 35 percent, and more people with HIV are getting the lifesaving medications they
need.
Article link: http://www.nlm.nih.gov/medlineplus/news/fullstory_147345.html
Source website: http://www.nlm.nih.gov/
Flu Drug Fighting Resistant Strains to Seek U.S. Approval
July 17, 2014
The first new type of flu drug in more than a decade could seek U.S. regulatory
approval as early as next year, aided by U.S. government efforts to combat pandemics
and biological threats.
Japan’s Fujifilm Holdings Corp. (4901) and partner MediVector Inc. have enrolled more
than half the 1,600 patients needed for advanced U.S. studies on the medicine called
favipiravir, Kouichi Yamada, senior operations manager of Fujifilm’s pharmaceutical
products division said in an interview. They plan to complete the trials around March
and file for approvals thereafter.
Article link: http://www.bloomberg.com/news/2014-07-17/flu-drug-fighting-resistantstrainsto-seek-u-s-approval.html
Amgen parathyroid drug found effective in kidney patient trial
July 17, 2014
An experimental drug proved effective in a late-stage study in reducing excess levels of
a hormone associated with a serious condition often seen in patients with chronic
kidney disease requiring dialysis, Amgen Inc said on Thursday.
Article link: http://www.reuters.com/article/2014/07/17/amgenthyroididUSL2N0PS2V620140717
30
Study Finds Many Flu Patients Not Treated Appropriately
July 17, 2014
Antiviral drugs aren't prescribed often enough for patients at high risk for flu
complications, while too many of them receive unneeded antibiotics, a new study says.
The findings show that doctors require more training about the proper use of antiviral
and antibiotic drugs in treating flu patients, the researchers said. Unnecessary use of
antibiotics contributes to the development of antibiotic resistance.
Article link: http://consumer.healthday.com/infectious-disease-information-21/
antibiotics-news-30/many-flu-patients-incorrectly-medicated-study-finds-689808.html
FDA committee to discuss adverse effects of testosterone products
July 17, 2014
The U.S. Food and Drug Administration has called an advisory committee meeting on
Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of
testosterone replacement therapy.
The FDA has called for a joint meeting of the bone, reproductive and urologic drugs
advisory committee and the drug safety and risk management advisory committee.
Article link: http://www.reuters.com/article/2014/07/17/us-fdadrugsafetyidUSKBN0FM2G320140717
Antipsychotics Linked to Lower Brain Volume in Schizophrenia Patients
July 18, 2014
Antipsychotic drugs are associated with a slight decrease in both brain cells and
connections between brain cells in schizophrenia patients, a new study indicates.
However, this loss of what is called brain volume does not worsen schizophrenia
symptoms or affect overall mental function, researchers reported in the study published
online July 18 in the journal PLoS One.
Article link: http://consumer.healthday.com/general-health-information-16/prescriptiondrugnews-551/antipsychotics-lower-brain-volume-in-schizophrenia-patients-studyshows689921.html
Pancreatic cancer treatment that almost never was lands key FDA win
July 21, 2014
Aduro BioTech's immune system-boosting treatment for fighting deadly pancreatic
cancer won "breakthrough therapy" designation from regulators, the small Berkeley
company said Monday.
31
The breakthrough therapy tag can accelerate approval of badly needed drugs from
years to 60 days by speeding the Food and Drug Administration review of drugs that
are a "substantial improvement" over existing therapies.
Article link:
http://www.bizjournals.com/sanfrancisco/blog/biotech/2014/07/pancreaticcanceraduro-gvax-steve-jobs.html
Source website: http://www.bizjournals.com/
3D Hepatitis C Combo Effective in HIV Patients
July 21, 2014
An investigational drug combination for hepatitis C virus (HCV) was highly effective in
patients who also had HIV, a researcher reported.
In a multicenter, phase II/III, open-label trial, the so-called 3D combination of
investigational drugs with different viral targets cleared HCV in more than 93% of coinfected
patients treated for 12 weeks, according to Mark Sulkowski, MD, of Johns
Hopkins University.
Article link: http://www.medpagetoday.com/MeetingCoverage/IAC/46868
Asthma Drug May Help Those With Chronic Hives
July 21, 2014
A drug already used to treat moderate-to-severe allergic asthma appears to offer relief
to people with chronic hives who haven't been helped by standard medications, new
research suggests.
The prescription drug -- omalizumab (Xolair) -- is already available to treat hives,
following U.S. Food and Drug Administration approval earlier this year for that use.
Article link: http://consumer.healthday.com/respiratory-and-allergy-information-2/miscallergynews-17/asthma-drug-appears-to-help-chronic-hives-689967.html
Anti-Amyloid Drug Has Mixed Results
July 21, 2014
The amyloid plaque-busting drug crenezumab for Alzheimer's disease failed to meet its
primary endpoints in a phase II trial, but -- as was the case with another similar drug -the drug did show promise in a subgroup with mild symptoms.
Article link: http://www.medpagetoday.com/MeetingCoverage/AAIC/46866
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Probiotics might help lower blood pressure
July 21, 2014
Regularly consuming probiotics, or the “good” bacteria found in yogurt, milk and
cheese, may help control blood pressure, according to a new review of past studies.
Researchers found that consuming the proper amount of probiotics over at least two
months appeared to modestly lower blood pressure.
Article link: http://www.reuters.com/article/2014/07/21/us-probiotics-bloodpressureidUSKBN0FQ20M20140721
Antibiotic resistance could be 'next pandemic,' CDC says
July 22, 2014
Antibiotic resistance that turns ordinary disease-causing bacteria into illnesses that can't
be controlled could bring about the "next pandemic," Centers for Disease Control and
Prevention Director Tom Frieden warned at a National Press Club event Tuesday.
Article link: http://www.usatoday.com/story/news/nation/2014/07/22/antibioticresistancebacteria-drugs-cdc-lab-safety-mers-anthrax/13005415/
Source website: http://www.usatoday.com/
Trials of new drug to prevent Alzheimer's disease
July 23, 2014
An experimental drug that takes a new approach to Alzheimer's by targeting the buildup
of brain proteins is enrolling participants at a clinical trial at the Nathan Kline
Institute in Orangeburg, NY
Article link: http://www.lohud.com/story/news/health/2014/07/22/alzheimers-drugstudy/
13029159/
Source website: http://www.lohud.com/
Inovio Pharma's drug to treat cervical lesions meets trial goal
July 23, 2014
Inovio Pharmaceuticals said its drug to treat abnormal growth of pre-cancerous
cells on the surface of the cervix met its main goal in a mid-stage trial.
Article link: http://www.reuters.com/article/2014/07/23/us-inovio-pharmafdaidUSKBN0FS1JT20140723
33
Why a Trial for a Vertex Cystic Fibrosis Drug Combo Sent Mixed Signals.
July 23, 2014
The recent results of two highly-anticipated human studies of an experimental cystic
fibrosis drug developed by Vertex Pharmaceuticals showed that patients had a
statistically significant improvement in lung function, but many doctors characterized
the improvement only as “modest.”
Article link: http://blogs.wsj.com/pharmalot/2014/07/23/why-a-trial-for-a-vertexcysticfibrosisdrug-combo-sent-mixed-signals/
Acetaminophen No Better Than Placebo for Back Pain
July 23, 2014
About two-thirds of adults have lower back pain at some point in their lives, and most
are told to take acetaminophen, sold under brand names like Tylenol, Anacin and
Panadol. Medical guidelines around the world recommend acetaminophen as a first-line
treatment.
Article link: http://well.blogs.nytimes.com/2014/07/23/acetaminophen-no-betterthanplacebofor-back-pain/?ref=health
Source website: http://well.blogs.nytimes.com/
Monitoring, Dose Adjustment for Pradaxa?
July 23, 2014
Blood level monitoring and dose adjustment for dabigatran (Pradaxa) could reduce
major bleeding risk by as much as 20% compared with unadjusted use, according to
company documents allegedly hidden from physicians and regulators.
Article link: http://www.medpagetoday.com/Cardiology/Arrhythmias/46901
Sanofi Pasteur starts shipping 2014 flu vaccine
July 23, 2014
The first batch of vaccines for the upcoming flu season is on its way to pharmacies,
hospitals and doctors offices. Some 65 million doses Sanofi Pasteur’s Fluzone vaccines
were approved for release earlier this week by the Food and Drug Administration.
Article link: http://www.drugstorenews.com/article/sanofi-pasteur-starts-shipping-2014flu-vaccine
Source website: http://www.drugstorenews.com/
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More US girls now getting cervical cancer vaccine
July 24, 2014
More teen girls are getting a controversial cervical cancer vaccine but the increase isn't
much of a bump, the government reported Thursday.
Last year's rise follows a couple of years when the girls' HPV vaccination rate was flat
and health officials worried that it wouldn't budge. For girls ages 13 to 17, the rate is
now up to about 38 percent of girls, from 33 percent.
Article link: http://hosted.ap.org/dynamic/stories/U/US_MED_HPV_VACCINATIONS?
SITE= AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2014-07-24-13-56-04
Keryx drug improves phosphorus, iron in kidney patients –trial
July 24, 2014
A pivotal trial of Keryx Biopharmaceuticals' experimental drug Zerenex showed
that it improved levels of serum phosphorus and iron in patients on kidney dialysis,
according to results published on Thursday.
The trial involved 441 patients, according to the Journal of the American Society of
Nephrology, which published the results.
Article link: http://www.reuters.com/article/2014/07/24/keryx-idUSL2N0PZ2V320140724
FDA reviewing what could be first biosimilar drug
July 24, 2014
The Food and Drug Administration is reviewing research data on what could become the
first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic
drug.
Nearly five years after Congress passed a law enabling future approval of biosimilars,
for the first time the FDA has accepted an application to sell a similar, but not identical,
version of a biologic drug.
Article link: http://hosted.ap.org/dynamic/stories/U/ US_NOVARTIS_BIOSIMILAR_DRUG?
SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT
FDA approves Flonase allergy relief for sale over-the-counter in the United
States
July 24, 2014
No. 1 prescribed allergy treatment ingredient1 to be available OTC
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug
Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50
35
mcg spray), containing the No. 1 prescribed allergy treatment ingredient1, as an overthecounter (OTC) treatment for temporary relief of the symptoms of hay fever or
upper respiratory allergies
Article link: http://www.gsk.com/media/press-releases/2014/fda-approves-flonaseallergyrelief-for-sale-over-the-counter-in.html
Source website: http://www.gsk.com/
Drugs to increase 'good' cholesterol may not cut deaths
July 28, 2014
Drugs that have been investigated to increase so-called “good” cholesterol may not
prevent deaths, heart attacks or strokes as many hoped, according to a new analysis.
Due to limitations in existing studies and ongoing experiments involving these and other
drugs, researchers not involved with the analysis caution that it’s too early to give up
on medications that increase high-density lipoprotein (HDL) cholesterol, however.
Article link: http://www.reuters.com/article/2014/07/28/us-hdl-cholesterolmedicationidUSKBN0FX1R520140728?
feedType=RSS&feedName=healthNews
House passes bill aimed at reducing prescription drug abuse
July 29, 2014
The House on Tuesday passed legislation by voice vote to establish enforcement
standards for prescription drug abuse.
Specifically, the measure would amend the Controlled Substances Act to modify the
definition of "imminent danger to the public health or safety" so that it applies to drugs
that pose present or foreseeable health risks.
Article link: http://thehill.com/blogs/floor-action/house/213692-house-passes-bill-aimedatreducing-prescription-drug-abuse
Source website: http://thehill.com/
$1,000 SOVALDI NOW HEPATITIS TREATMENT OF CHOICE
July 29, 2014
The price may be high but so is demand. A new $1,000-per-pill drug has become the
treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects
more than 3 million.
Even with insurers reluctant to pay, Sovaldi prescriptions have eclipsed those for all
other hepatitis C pills combined in a matter of months, new data from IMS Health
indicate. The promise of a real cure, with fewer nasty side effects, has prompted
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thousands to get treated.
Article link: http://hosted.ap.org/dynamic/stories/U/ US_HEPATITIS_DRUG?
SITE=AP&SECTION=HOME&TEMPLATE =DEFAULT&CTIME=2014-07-29-03-06-19
Clinical Trials may be Compromised by Online Patient Chatter
July 30, 2014
Are patients jeopardizing clinical trials by discussing them on social media?
There is growing fear in the medical community and the pharmaceutical industry that
an increasing number of people who participate in clinical trials may indeed compromise
research by chatting about treatments, side effects and enrollment tips on Facebook,
online forums and blogs, according to The Wall Street Journal.
Article link: http://blogs.wsj.com/pharmalot/2014/07/30/clinical-trials-may-becompromisedby-online-patient-chatter/
Naltrexone may be effective in diminishing impulse control disorders in
Parkinson's disease patients
July 30, 2014
Up to 20 percent of Parkinson's disease (PD) patients and their families may confront a
common but largely unrecognized challenge: the occurrence of impulse control
disorders (ICDs) such as compulsive gambling, sexual behavior, eating, or spending. Yet
the presence of PD in these patients can severely limit or complicate treatment options.
A team of investigators from the Perelman School of Medicine at the University of
Pennsylvania and the Parkinson's Disease Research, Education and Clinical Center
(PADRECC) at the Philadelphia Veterans Affairs Medical Center conducted a pilot study
and found that the opioid antagonist naltrexone may be an effective treatment for
diminishing ICD symptoms in PD patients. The results were published in the journal
Neurology.
Article link: http://www.sciencedaily.com/releases/2014/07/140730120145. htm?
utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+
sciencedaily+%28Latest+Science+News+--+ScienceDaily%29
Source website: http://www.sciencedaily.com/
FDA Boosts Sarepta With Prognosis for its Rare Disease Drug.
July 30, 2014
For the first time in months, Sarepta Therapeutics investors and parents of children with
Duchenne muscular dystrophy received some good news. A top FDA official says the
agency is exploring all “potential pathways” to approve new drugs to treat the rare
childhood disease, which causes muscles in boys to stop working and eventually results
37
in death because they can no longer breathe.
Article link: http://blogs.wsj.com/pharmalot/2014/07/30/fda-boosts-sarepta-withprognosisfor-its-rare-disease-drug/
Sanofi, Regeneron Drug Cuts Cholesterol in 9 Studies
July 30, 2014
Sanofi (SAN) and Regeneron Pharmaceuticals (REGN)’s cholesterol drug cut levels
of the artery-clogging protein in nine trials, and reduced the rate of heart attack, stroke
and death in one test, as the companies race with Amgen (AMGN) to get a new
treatment to market.
Article link: http://www.bloomberg.com/news/2014-07-30/sanofi-cholesterol-drugmeetsmain-goal-of-9-trials.html
Menopause HT Doesn't Touch Arterial Plaque
July 30, 2014
Hormone replacement therapy early in menopause does not reduce the risk of
atherosclerosis in low-risk women, a finding now confirmed by data from the KEEPS
trial.
During 4 years in the trial, women's carotid intima-media thickness (CIMT) rose
similarly whether they got progesterone (Prometrium) with oral conjugated equine
estrogen (Premarin) or with transdermal estradiol (Climara) or placebo, S. Mitchell
Harman, MD, PhD, of the Phoenix VA Health Care System, and colleagues found.
Article link: http://www.medpagetoday.com/Cardiology/Atherosclerosis/46998
The Pill linked to breast cancer risk for younger women
August 1, 2014
A new statistical analysis finds that women under age 50 who were diagnosed with breast
cancer were also more likely to have recently been on some versions of the Pill.
The increased cancer risk still translates to less than a one percent chance of developing
breast cancer for most younger women, researchers emphasize, so the results should not
outweigh the many benefits of taking oral contraceptives.
Source website: reuters.com
38
Statin guidelines change, but your doctor may not go along
August 4, 2014
By Will Boggs MD
New guidelines from the American College of Cardiology and American Heart Association
would change the way doctors prescribe cholesterol-lowing statin drugs, but not every doctor
agrees with the new strategy.
Amgen blood cancer drug succeeds in late-stage study
August 4, 2014
Amgen said on Monday its Kyprolis combined with standard treatment helped patients
with relapsed multiple myeloma live significantly longer before their blood cancer worsened,
compared with the standard therapy, according to interim data from an eagerly-anticipated
late stage study.
Ebola Drug Made From Tobacco Plant Saves U.S. Aid Workers
August 4, 2014
A tiny San Diego-based company provided an experimental Ebola treatment for two
Americans infected with the deadly virus in Liberia. The biotechnology drug, produced with
tobacco plants, appears to be working.
Source website: bloomberg.com
Baby aspirin? Many doctors don't recommend, despite guidelines
August 5, 2014
A majority of middle-aged men and women eligible to take aspirin to prevent heart attack
and stroke do not recall their doctors ever telling them to do so, according to a University of
Rochester study of a national sample of more than 3,000 patients.
Source website: sciencedaily.com
Hopes build for new Novartis heart failure drug
August 5, 2014
Expectations are building for a new heart failure drug from Novartis viewed as a likely
multibillion-dollar seller, with two surveys of cardiologists published on Tuesday highlighting
its potential.
A large clinical trial with LCZ696 was stopped early in March because the benefit to patients
was overwhelmingly positive. Just how good the drug was will be disclosed at a medical
meeting in Spain at the end of this month.
39
FDA authorizes Ebola test; vaccine will probably take until 2015
August 6, 2014
The FDA has authorized use of an unapproved Ebola virus test under a special emergency use
provision, although efforts to develop a vaccine for the deadly illness are unlikely to
bear fruit until 2015, officials say.
Source website: latimes.com
Study: Pharmacist adherence interventions help lower overall health costs
August 6, 2014
Community pharmacists can dramatically help their patients stick to their prescription
regimens, according to a new study led by researchers at the University of Pittsburgh School
of Pharmacy. The findings, reported Monday in Health Affairs, also suggest that greater
adherence to medications can lead to a reduction in emergency room visits and hospital
admissions, thereby lowering healthcare costs for a variety of chronic conditions, including
diabetes and asthma.
Source website: drugstorenews.com
Daily Aspirin May Help Prevent Cancer, Study Shows
August 6, 2014
Taking aspirin every day appears to reduce the odds of developing and dying from colon,
stomach or esophageal cancer, a new study suggests.
Based on a review of available studies, researchers determined that the benefits of aspirin
therapy for preventing cancer outweigh the risks. Millions of people already take this
inexpensive drug to prevent or treat heart disease.
Source website: consumer.healthday.com
Researchers concerned about safety of new drugs
August 6, 2014
Study compared warning and withdrawal rates for drugs released before and after the drug
industry increased funding to the FDA to expedite drug approvals
What's safer: a newly approved drug or one that has been on the market much longer?
Newer drugs have a one in three chance of acquiring a black box warning or being
withdrawn for safety reasons within 25 years of their approval, according to a new study by
researchers from Cambridge Health Alliance /Harvard Medical School, Boston Medical Center
(BMC)/Boston University School of Medicine (BUSM), City University of New York School of
Public Health, and Public Citizen. The study, published today in the August issue of Health
Affairs, is the largest on this topic, encompassing all of the drugs approved by the U.S. Food
and Drug Administration (FDA) over a 35-year period.
Source website: medicalnewstoday.com
40
Low Vitamin D Levels May Boost Alzheimer's Risk, Study Finds
August 6, 2014
Older adults with too little vitamin D in their blood may have twice the risk of developing
Alzheimer's disease as seniors with sufficient levels of the "sunshine vitamin," a new study
finds.
The research -- based on more than 1,600 adults over age 65 -- found the risk for
Alzheimer's and other forms of dementia increased with the severity of vitamin D deficiency.
Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns
August 11, 2014
RAC Recalls of pharmaceutical products have surged in recent years, and 2014 is already
shaping up to be the biggest year for serious drug recalls in the last decade, according to
data made publicly available by the US Food and Drug Administration (FDA) late last month.
Source website: raps.org
Short Latent TB Therapy Matches Standard Care
August 11, 2014
Short courses of rifamycin-containing treatment regimens prevented active tuberculosis as
well as standard monotherapy did, researchers reported.
In a Bayesian network meta-analysis, some of the rifamycin-containing regimens also were
less likely to cause liver damage than standard therapy with isoniazid (Nydrazid), according
to Helen Stagg, PhD, of University College London, and colleagues.
Source website: medpagetoday.com
Guidelines: Treat Sickest HCV Patients First
August 11, 2014
All patients with chronic hepatitis C (HCV) can benefit from new treatment regimens but
some should get therapy more urgently than others, according to new guidelines. Patients
with advanced fibrosis or who have had a liver transplant are at the "highest need for urgent
treatment," according to Donald Jensen, MD, of the University of Chicago Medical Center,
co-chair of an HCV guidelines panel organized by the Infectious Diseases Society of America
and the American Association for the Study of Liver Diseases, in collaboration with the
International Antiviral Society-USA (IAS-USA).
41
Study: Digoxin Risky for New Afib
August 11, 2014
Digoxin was associated with increased risk of death in patients with newly diagnosed atrial
fibrillation (Afib), independent of drug adherence, kidney function, cardiovascular
comorbidities, and concomitant therapies, researchers reported.
Bisphosphonates for osteoporosis not associated with reduced breast cancer risk, study
suggests
August 11, 2014
An analysis of data from two randomized clinical trials finds that three to four years of
treatment with bisphosphonates to improve bone density is not linked to reduced risk of
invasive postmenopausal breast cancer.
Source website: sciencedaily.com
Statins Don’t Require Routine Liver Tests
August 11, 2014
When statins first came into wide use, warnings about possible liver damage were common,
and some patients on the cholesterol-lowering drugs have their liver function monitored.
Now a study has found that the risk was probably exaggerated.
Source website: nytimes.com
Many meds taken by seniors can raise risk of falls
August 12, 2014
Half of the 20 most commonly prescribed medications taken by older adults may raise the
risk of falls, according to new research. Painkillers and antidepressants were most strongly
tied to a greater likelihood of being injured in a fall, the study of 64,000 Swedes over age
65 found. Severe injuries were significantly more common with 11 out of the 20 medications
studied.
From Riches to Rags: Vertex Discontinues Incivek as Sales Evaporate.
August 12, 2014
Talk about a reversal of fortunes.
Three years after being heralded as the fastest drug launch ever and quickly racking up $1
billion in sales, the Incivek hepatitis C treatment will be discontinued this coming October by
Vertex Pharmaceuticals .
Source website: wsj.com
42
U.S. advisory panel recommends Prevnar 13 vaccine for elderly
August 13, 2014
An influential U.S. medical advisory panel on Wednesday recommended that people 65 and
older be given Pfizer Inc's blockbuster Prevnar 13 vaccine to protect against pneumococcal
bacteria that can cause pneumonia and other infections.
Children Prescribed Growth Hormone May Face Stroke Risk Later: Study
August 13, 2014
Children who are prescribed human growth hormone may be at greater risk of a stroke in
early adulthood than their peers are, a new study suggests.
While the study raises important questions about the safety of human growth hormone
treatments, the study's French researchers encouraged parents to discuss the pros and cons
of treatment with their child's physician.
Injecting bacteria shrinks tumors in dogs and one patient: study
August 13, 2014
Common soil bacteria injected into solid cancers in pet dogs and one human patient shrank
many of the tumors, scientists reported on Wednesday.
The preliminary findings offered hope that the experimental treatment could turn out to be
more effective than existing cancer therapies for some inoperable tumors such as those of
the lung, breast, and pancreas, which often fail to respond to radiation and chemotherapy.
API Provides Open Access to FDA Recall Data
As part of the Food and Drug Administration’s recently launched openFDA initiative, the
regulatory agency is for the first time offering an application programming interface
providing web developers and researchers direct access to millions of reports on drug
adverse events and medication errors that have been submitted to the FDA since 2004.
Article link: http://www.healthdatamanagement.com/news/ API-Provides-Open-AccesstoFDA-Recall-Data-48453-1.html
Source website: http://www.healthdatamanagement.com/
43
Contraception By Remote Control? Implantable Chip Nears Trials
In the not-too-distant future, an implanted microchip could be the best form of birth control.
Backed by the Bill & Miranda Gates Foundation Family Planning program, MicroCHIPS is
starting pre-clinical testing of a new wireless device that delivers 30 micrograms of
levonorgestrel — a synthetic hormone used in many contraceptives — every day for up to 16
years. That is far longer than any intrauterine device (IUD) on the market. (Copper IUDs
can last for 10 years, while hormonal ones last for about five years). The chip even comes
with a remote control, which lets women turn it off and on again with the press of a button.
It’s not quite ready for the widespread human use yet; researchers are still working out how
to encrypt the chips, important in preventing hackers from seriously upsetting someone’s life
plans. If all goes according to plan, the company hopes the device will become available by
2018, and the technology could be adapted to deliver a number of other drugs as well.
Article link: http://www.nbcnews.com/#/tech/innovation/contraception-remotecontrolimplantablechip-nears-trials-n149771
Source website: http://www.nbcnews.com/
Zohydro details timeframe for new Zohydro version
The drugmaker Zogenix says a harder-to-abuse version of its powerful painkiller Zohydro
could be reviewed by regulators this fall and, if approved, might hit the market early next
year.
The San Diego company said Wednesday that it recently met with Food and Drug
Administration representatives, and it expects to submit an extended release, capsule
version of Zohydro to the FDA by October.
Article link: http://www.miamiherald.com/2014/07/02/4214589/zohydro-detailstimeframefor.
html
Source website: http://www.miamiherald.com/
German database study hints diabetes drug cuts Alzheimer's risk
A large German study is the latest clinical trial to suggest that a cheap generic treatment for
diabetes can stave off symptoms of Alzheimer's disease, although conclusive proof from a
more formal trial could be about five years away.
Article link: http://www.reuters.com/article/2014/07/14/us-alzheimers-preventionactosidUSKBN0FJ0VJ20140714
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RECALLS*
Product
Type
Drugs
Product Description
Code info.
Super ARTHGOLD 500mg,
120 Capsule Bottle,
Dietary Supplement.
UPC: 7 99475 35350 5.
Lot #: L1P1-6100
(expiry
6/25/2016) and
L1P2-6000
(expiry
9/16/2016).
Class I
Drugs
Lite Fit USA, For Men &
Women, Extreme Fat
Burner, Suppresses
Appetite, Boosts
Metabolism, Limits Fat
Absorption, Increases
Energy, Prevents lipid
formation by limiting fat
absorption 30 pills
/Bottle
Lot #13165; Exp.
05/17
Class I
Drugs
Soliris (eculizumab), 300
mg/30 mL (10 mg/mL),
30 mL Single-Use Vial, Rx
only
NDC 25682-001-01
UPC 3 25682-001-01 6.
Class I
Drugs
Taztia XT (Diltiazem HCl)
Capsules, 120 mg, Rx,
Packaged and labeled as
Thiamine.
NDC 62037-0696-90
Oxycodone HCl Oral
Concentrate, 20 mg/mL,
Rx (C-II) Packaged and
labeled as Morphine
Sulfate 20 mg/mL, NDC
00527-1426-36
Lots: 10002-1,
00006-1, Exp
08/14; 10003A,
Exp 11/14;
10004A, Exp
02/15; 10005A,
10005AR,
10007A,
10006A, Exp
07/15; and
10008A, Exp
08/15
Use By:
5/31/2013, Lot:
0021OC, NDC
62037-0696-90
Lot #: 002HZI
Use By:
7/20/2013 NDC:
00527-1426-36
Class I
Drugs
Class
Class I
Reason for Recall
Recalling firm
Marketed Without an
Approved
NDA/ANDA; Product
contains undeclared
indomethacin,
diclofenac, and
chlorzoxazone.
Marketed Without an
Approved
NDA/ANDA: Bacai,
Inc. DBA Ky Duyen
House is voluntarily
recalling Lite Fit USA,
lot 13165, due to
undeclared
sibutramine, making
it an unapproved
new drug.
Presence of
Particulate Matter:
Product failed the
appearance for the
presence of visible
particles under
labeled storage
condition.
Sung Soo Kim
Labeling: Label Mix
Up; packages labeled
as Thiamine actually
contain Diltiazem
Capsules
Labeling: Label Mix
up; product labeled
as Morphine Sulfate
20 mg/mL actually
contained
OxyCODONE HCl 20
mg/mL
Bacai Inc. Dba
Ky Duyen
House
Alexion
Pharmaceutical
s, Inc.
Shamrock
Medical
Solutions
Group LLC
Shamrock
Medical
Solutions
Group LLC
45
Product
Type
Drugs
Drugs
Drugs
Drugs
Drugs
Product Description
Code info.
metFORMIN ER Tablets,
500 mg, Rx, Packaged
and labeled as
metFORMIN Immediate
Release (IR), Repackaged
By: Shamrock Medical
Solutions Lewis Center,
Ohio, NDC 53746-178-01
Carbidopa and Levodopa
Tablets USP,
25mg/100mg, 1000
count bottle, Rx only,
NDC 0093-0293-10
Lot #: 00267J
Use By:
7/28/2012 NDC:
53746-178-01
Reason for Recall
Recalling firm
Class I
Labeling: Label Mix
up; product labeled
did not indicated
Extended Release
Shamrock
Medical
Solutions
Group LLC
lot 29C220, Exp.
11/15
Class II
Teva
Pharmaceutical
s USA
Risperdal CONSTA
(risperiDONE), 25 mg
Dose Pack, Rx Only,
Single Use Only Janssen
Pharmaceuticals Inc.,
Titusville, NJ 08560 NDC
50458-306-11
Vitamin B12
Methylcobalamin with
MIC Injection USP 1000
mcg/ml, Sterile, 10 ml
vial and 30 ml vial. For IM
or Deep SQ Use, Multiple
Dose Vial.
Vial - 4212AAP1,
Kit - 309316,
Exp. 07/15
Class II
Failed Tablet/Capsule
Specifications: Teva is
recalling one lot of
Carbidopa and
Levodopa Tablets
USP, 25mg/100mg
due to the potential
for superpotent
tablets.
Non-Sterility: Janssen
is recalling one lot of
Risperdal CONSTA
(risperiDONE) due to
a sterility failure in a
stability sample
All lot numbers
and exp dates
Class II
Medical Supply
Liquidators Llc
Vitamin B12
Methylcobalamin
Injection USP 1000
vial and 30 ml vial. For IM
Dose Vial
All lot numbers
and exp dates
Class II
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
recalled because the
manufacturing firm is
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Class
Janssen
Pharmaceutical
s, Inc.
Medical Supply
Liquidators Llc
46
Product
Type
Drugs
Product Description
Code info.
BCAA 4% Branched Chain
Amino Acid Injection
USP, Sterile, 30 ml vial,
For IM or Deep SQ Use,
Multiple Dose Vial
All lot numbers
and exp dates
Class II
Drugs
Vitamin B12
Cyanocobalamin
Injection USP 1000
vial and 30 ml vial, For IM
Dose Vial
All lot numbers
and exp dates
Class II
Drugs
Vitamin B6 Pyridoxine
HCL for Injection USP,
100 mg/ml, Sterile, for
IM or Deep SQ Use,
Multiple Dose 30 ml vial
All lot numbers
and exp dates
Class II
Drugs
Vitamin B12
All lot numbers
Methylcobalamin 5000
and exp dates
Injection USP 5000
mcg/ml, 10 ml vial and 30
ml vial, Sterile, for IM or
Deep SQ Use, Multiple
Dose Vial
Class II
Drugs
MIC Injection USP,
Sterile, 10 ml vial and 30
ml vial, For IM or Deep
SQ Use, Multiple Dose
Class II
All lot numbers
and exp dates
Class
Reason for Recall
Recalling firm
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
47
Product
Type
Product Description
Code info.
Class
Drugs
Super MIC B Complex for
L-Carnitine for Injection
USP with
mcg/ml, Sterile, for IM or
Deep SQ Use, Multiple
Dose Vial.
All lot numbers
and exp dates
Class II
Drugs
Vitamin B12
Cyanocobalamin with
MIC Injection USP 1000
mcg/ml, packaged in 10
ml vials and 30 ml vials,
Sterile, for IM or Deep SQ
Use, Multiple Dose Vial
All lot numbers
and exp dates
Class II
Drugs
B Complex for Injection
USP with
mcg/ml, Sterile, for IM or
Deep SQ use, multiple
dose vial, packaged in 10
ml vials and 30 ml vials.
All lot numbers
and exp dates
Class II
Drugs
Vitamin B12
Hydroxocobalamin
Injection USP 1000
vial, For IM or Deep SQ
Use, Multiple Dose Vial
All lot numbers
and exp dates
Class II
Vial
Reason for Recall
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
Recalling firm
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
48
Product
Type
Product Description
Code info.
Drugs
Lipo 8 Injection USP 200
mg/ml, packaged in 30
ml vials, Sterile
All lot numbers
and exp dates
Class II
Drugs
G.A.C. 375 Injection USP,
packaged in 30 ml vials,
Sterile, For IM or Deep
Vial
All lot numbers
and exp dates
Class II
Drugs
L-Carnitine Injection USP
100 mg/ml, packaged in
30 ml vials, Sterile, For
IM or Deep SQ Use,
Multiple Dose Vial
All lot numbers
and exp dates
Class II
Drugs
Glutathione Injection
USP, 200 mg/ml,
packaged in 30 ml vials,
Sterile, For IM of Deep
Vial
All lot numbers
and exp dates
Class II
Drugs
Cephalexin Capsules,
Lot #: a)
USP, 250 mg, packaged in AGL0098B,
Class
Class II
Reason for Recall
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
Marketed without an
Approved
NDA/ANDA; IM and
SQ injectable
products are being
not registered with
the FDA as a drug
manufacturer
CGMP Deviations:
These products are
Recalling firm
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Medical Supply
Liquidators Llc
Caraco
Pharmaceutical
49
Product
Type
Drugs
Product Description
Code info.
AGL0099B,
AGL0100B,
AGL0101B, Exp
09/14;
AGM0073B,
AGM0074B, Exp
04/15;
AGM0125B,
AGM0126B, Exp
07/15;
AGM0158B, Exp
09/15; b)
AGL0092A,
AGL0093A,
AGL0094A,
AGL0095A,
AGL0096A,
AGL0097A,
AGL0102A,
AGL0103A,
AGL0104A,
AGL0105A, Exp
09/14;
AGM0067A,
AGM0068A,
AGM0069A, Exp
03/15;
AGM0070A,
AGM0071A,
AGM0072A,
AGM0085A,
AGM0086A, Exp
04/15;
AGM0127A,
AGM0128A,
AGM0129A,
AGM0130A,
AGM0131A, ...
More
Cephalexin Capsules,
Lot #: a)
USP, 500 mg, packaged in AGL0058B,
a) 100-count bottles
AGL0059B,
(NDC 62756-294-88) and AGL0060B,
b) 500-count bottles
AGL0061B, Exp
(NDC 62756-294-13), Rx
06/14;
Class
a) 100-count bottles
(NDC 62756-293-88) and
b) 500-count bottles
(NDC 62756-293-13), Rx
only
Class II
Reason for Recall
Recalling firm
being recalled
because they were
manufactured with
active
pharmaceutical
ingredients (APIs)
that were not
manufactured with
good manufacturing
practices.
Laboratories,
Ltd.
CGMP Deviations:
These products are
being recalled
because they were
manufactured with
active
Caraco
Pharmaceutical
Laboratories,
Ltd.
50
Product
Type
Product Description
Code info.
only
Drugs
Tetrahydrozoline HCL, 16
kg drum. Societa Italiana
Medicinali Scandicci
(S.I.M.S.), NDC 126600048 CAS #522-48-5
Alprazolam Tablets, USP
0.25 mg, UD 100 Tablets
(10 x 10), Rx Only, NDC
63739-644-10
AGL0062B,
AGL0063B,
AGL0064B, Exp
07/14;
AGL0083B,
AGL0084B,
AGL0085B,
AGL0086B,
AGL0087B,
AGL0088B,
AGL0089B,
AGL0090B, Exp
08/14;
AGL0120B,
AGL0121B,
AGL0122B,
AGL0123B, Exp
11/14;
AGM0001B,
AGM0002B,
AGM0003B,
AGM0004B, Exp
12/14;
AGM0021B,
AGM0022B,
AGM0023B,
AGM0024B, Exp
01/15;
AGM0031B,
AGM0032B,
AGM0033B,
AGM0034B, Exp
02/15;
AGM0053B,
AGM0054B, ...
More
Lot: 168.862,
Expiry: 6/2017
Drugs
Lot 102492, exp
01/2016
Class
Reason for Recall
Recalling firm
pharmaceutical
ingredients (APIs)
that were not
manufactured with
good manufacturing
practices.
Class II
Class II
CGMP Deviations;
Stored/dispensed in
a non-GMP
compliant warehouse
at S.I.M.S., Italy.
Presence of Foreign
Substance; tablets
may contain stainless
steel metal
SST
Corporation
Mckesson
Packaging
Services
51
Product
Type
Product Description
Drugs
Alcohol-Free Hand
Sanitizer, 1. fl. oz. (30 ml)
bottles capped with
white sprayer, OTC,
contains Benzalkonium
chloride. NDC: 19392120-03. Labeled A) Anne
Arundel County Mental
Health Agency, Inc., B)
Family Advocacy
Program, and C)
Henderson Community
College Nursing.
Dermamedics Post
Procedure Cream, 1
ounce containers which
were distributed with a
SKU number of DM 1026
Lot #:
MB140417;
Expiry: 04/2017.
Class II
all lot codes
Class II
Drugs
Dermamedics Calm &
Correct Cream in 2 oz.
containers with SKU
number DM1020.
all lot codes, .25
oz and 2 oz sizes
Class II
Drugs
Dermamedics Baby's
Relief Calm and Repair
Cream in 2 oz. containers
with a SKU number of
DM1016 and 0.25
containers with a SKU
number of PS 1016; and
Therametics Baby's Relief
Calm and Repair Cream
in 2 oz. containers with a
SKU number of BR008.
Dermamedics
Complexion Repair
Topical Rehydrating
all lot codes
Class II
all lot codes
Class II
Drugs
Drugs
Code info.
Class
Reason for Recall
Recalling firm
particulates
Microbial
Contamination of
Non-Sterile Product
HLI dba
Humphreyline
Inc
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Marketed without an
Approved
NDA/ANDA: FDA has
Dermamedics,
L.L.C.
Dermamedics,
L.L.C.
Dermamedics,
L.L.C.
Dermamedics,
L.L.C.
52
Product
Type
Drugs
Product Description
Emulsion which was
distributed in 50 ml
number of DM 1011 and
Therametics Complexion
Repair Topical
Rehydrating Emulsion
which was distributed in
50 ml containers with a
SKU number of CR002.
Dermamedics Calm and
Correct Serum, 2 oz.
number of BB10062 and
4 oz. containers with a
SKU number of BB10068.
Code info.
Class
Reason for Recall
Recalling firm
determined that the
products are
unapproved new
drugs and
misbranded.
all lot codes
Class II
Drugs
Dermamedics Post
Procedure Cream 1 oz.
containers in the
Dermamedics Post-Laser
Treatment System with a
SKU number of DM 1019
all lot codes
Class II
Drugs
Dermamedics Calm and
Correct Cream 2 oz.
containers in the
Dermamedics Post
Medical Procedure Kit
SK1005
all lot codes
Class II
Drugs
Dermamedics
Complexion Repair
Topical Rehydrating
Emulsion in 50 ml and 30
ml containers in the
Dermamedics
Complexion Repair Acne
Treatment System Kit
with SKU numbers of DM
1013 and DM 1025,
all lot codes 30
ml and 50 ml
Class II
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Dermamedics,
L.L.C.
Dermamedics,
L.L.C.
Dermamedics,
L.L.C.
Dermamedics,
L.L.C.
53
Product
Type
Drugs
Drugs
Product Description
respectively; Therametics
Complexion Repair
Topical Rehydrating
Emulsion which was
distributed in 50 ml
number of CR002 and in
50 ml containers in the
Repair Acne Treatment
System Kit with a SKU
number of CR1005; and
in 30 ml containers in the
Repair Acne Travel Kit
CR1007.
Repair Topical
Rehydrating Emulsion in
50 ml and 30 ml
containers in the
Complexion Repair Acne
Treatment System Kit
and the Complexion
Repair Acne Travel Kit
with SKU numbers of
CR1005 and CR1007,
respectively.
triple therapy,
LANSOPRAZOLE DR
Capsules USP 30mg,
CLARITHROMYCIN
Tablets USP 500mg,
AMOXICILLIN Capsules
USP 500mg, 8 count
Blister Pack Lansoprazole
DR Capsules USP &
Clarithromycin Tablets
USP, NDC# 0093-8055-78
Code info.
Class
Reason for Recall
Recalling firm
all lot codes 30
ml and 50 ml
Class II
Marketed without an
Approved
NDA/ANDA: FDA has
determined that the
products are
unapproved new
drugs and
misbranded.
Dermamedics,
L.L.C.
35427772A,
35427773A,
35427774A,
35427916A,
35428048A,
35428051A,
Exp. 04/14;
35428127A,
35428218A,
Exp. 07/14;
35429573A,
35429574A,
35429575A,
Exp. 02/15;
35429697A,
Exp. 03/15;
Class II
Failed
Impurities/Degradati
on Specifications:
This recall is due to
out of specification
for impurities test
results obtained
during stability
testing for
Lansoprazole.
Teva
Pharmaceutical
s USA
54
Product
Type
Product Description
Drugs
Losartan Potassium and
Hydrochlorothiazide
Tablets, USP 100 mg/25
mg, 90-tablets per bottle,
Rx Only, NDC # 59746339-90
Drugs
Azor Tablets (amlodipine
and olmesartan
medoxomil) 10 mg*/40
mg, 30 count bottles, Rx
Only, NDC 65597-113-30
Drugs
Reason for Recall
Recalling firm
Class II
Presence of Foreign
Substance: Tablets
may contain dark
blemishes identified
as stainless steel.
Jubilant Cadista
Pharmaceutical
s Inc.
Lot #213655B
Exp 12/31/2014
Class II
Daiichi Sankyo
Pharma
Development
Benicar Tablets
(olmesartan medoxomil)
20 mg, 30 and 90 count,
Rx Only, NDC 65597-10330 and NDC 65597-10390
30 count - Lot
#0002055 Exp 11/30/2016; 90
count - Lot
#0002063 Exp 12/31/2016
Class II
Drugs
Benicar HCT Tablets
(olmesartan medoxomil,
hydrochlorothiazide) 20
mg/12.5 mg, 30 count
bottles, Rx Only, NDC
65597-105-30
Lot #0002106
Exp 11/30/2016
Class II
Drugs
Tribenzor Tablets
(olmesartan
medoxomil/amlodipine/h
ydrochlorothiazide), 40
mg/5 mg*/25 mg 30
count bottles, Rx Only
NDC 65597-116-30
Welchol Tablets
(colesevelam HCl) 625
mg, 180 count bottles, Rx
Only, NDC 65597-701-18
Lot #211836 Exp
- 11/30/2016
Class II
Lot NVWG Exp 11/30/2016
Class II
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
USP guidelines during
shipping
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping
Drugs
Code info.
35430184A,
Exp. 04/15.
Lot #14P0292,
Exp 04/2016
Class
Daiichi Sankyo
Pharma
Development
Daiichi Sankyo
Pharma
Development
Daiichi Sankyo
Pharma
Development
Daiichi Sankyo
Pharma
Development
55
Product
Type
Drugs
Product Description
Code info.
Benicar Tablets
(olmesartan medoxomil)
40 mg, 30 and 90 count,
Rx Only, NDC 65597-10430 and 65597-104-90
30 count - Lot
#0002096 Exp 12/31/2016; 90
count - Lot
#0002058 Exp 12/31/2016
Drugs
Benicar HCT Tablets
Lot #0002073
(olmesartan
Exp medoxomil/hydrochlorot 12/31/2016
hiazide) 40 mg/12.5 mg,
30 count bottles, Rx Only,
NDC 65597-106-30
Class II
Drugs
Benicar HCT Tablets
(olmesartan
medoxomil/hydrochlorot
hiazide) 40 mg/25 mg, 30
and 90 count bottles, Rx
Only, NDC 65597-107-30
and NDC 65597-107-90
Fagron, Phytobase
Cream, 500 g, RX only,
For prescription
compounding Natural
self-emulsifying oil-in
water vehicle for oilsolvents ingredients.
Contains Phytosomes
(Plant Oil Bodies), NDC
51552-1205-6.
Fagron, Pentravan Base
2.5 Kg, RX only, For
prescription compouning,
Oil-in-water emulsion,
PLO gel alternative,
Preserved and fragrancefree, NDC 51552-0919-8.
Fagron, Pentravan Plus
Base 2.5 Kg, RX only, For
prescription
compounding, Oil-inwater emulsion base
alternative to PLO gel,
30 count/Lot
#0002073 Exp 12/31/2016; 90
count/Lot
#0002078 Exp 12/31/2016
Class II
Lot # 13J30U17-015413;
Exp 10/15 Lot #
13J30-U16015425; Exp
10/15 Lot #
13I06-U05014199; Exp
10/15
Class II
Lot # 14C24U04-018189;
Exp. 03/17 Lot #
14C26-U02018214; Exp.
03/17
Class II
Microbial
Contamination of
Non-Sterile Products:
Fragon is recalling six
lots due to the
presence of mold.
Fagron, Inc
Lot # 14C03U09-017846;
Exp. 03/17 Lot #
14B28-U06017824; Exp.
03/17
Class II
Microbial
Contamination of
lots due to the
presence of mold.
Fagron, Inc
Drugs
Drugs
Drugs
Class
Class II
Reason for Recall
Recalling firm
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping.
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping.
Temperature Abuse;
various products
were not stored at
Controlled Room
Temperature as per
shipping.
Microbial
Contamination of
lots due to the
presence of mold.
Daiichi Sankyo
Pharma
Development
Daiichi Sankyo
Pharma
Development
Daiichi Sankyo
Pharma
Development
Fagron, Inc
56
Product
Type
Drugs
Drugs
Drugs
Drugs
Drugs
Product Description
Added emulsifier ad
viscosity-enhancing agent
for use with high
concentrations of active
ingredients.Preserved
and fragrance-free, NDC
51552-1285-8,
Alprazolam Tablets, USP,
0.25mg, Rx only, 1000
tablets, Sandoz Inc.,
Princeton, NJ --- NDC
0781-1061-10
Pramipexole
Dihydrochloride Tablets,
0.5 mg, Rx, packaged and
labeled to contain
Nebivolol tablets,
Repackaged By:
Shamrock Medical
Ohio, NDC 16714-586-01
Sulfamethoxazole and
Trimethoprim Tablets,
800 mg/160 mg, DOUBLE
STRENGTH, Rx, packaged
and labeled to contain
Sulfamethoxazole and
Trimethoprim Tablets,
400 mg/80 mg,
Repackaged By:
Shamrock Medical
Ohio, NDC 53746-272-01
Docusate Calcium Softgel
Capsules, 240 mg, OTC,
packaged and labeled to
contain Docusate Sodium
240mg, Repackaged By:
Shamrock Medical
Ohio, NDC 00904-577960
Levofloxacin 750 mg/250
mL D5W, Trinity Care
Code info.
Class
Reason for Recall
Recalling firm
Presence of Foreign
Substance; tablets
may contain stainless
steel metal
particulates
Labeling: Label Mix
up; product labeled
to contain Nebivolol
tablets actually
contained
Pramipexole
Dihydrochloride
tablets
Sandoz
Incorporated
Lot EJ9591
Class II
Use by
12/14/2012,
Lot# 002B90,
NDC 16714-58601
Class II
Lot 00288N, Use
By: 9/15/2012,
NDC 53746-27201
Class II
Labeling: Label Mix
up; product labeled
to contain
Sulfamethoxazole
and Trimethoprim
Tablets, 400 mg/80
mg instead of
Sulfamethoxazole
and Trimethoprim
Tablets, 800 mg/160
mg
Shamrock
Medical
Solutions
Group LLC
Lot #: 002H79,
Use By:
06/19/2013,
NDC: 009045779-60
Class II
Labeling: Label Mix
up; product labeled
to contain Docusate
Sodium 240mg
instead of Docusate
Calcium 240mg
Shamrock
Medical
Solutions
Group LLC
Rx 29184 Exp
5/28/14
Class II
Lack of Assurance of
Sterility; All lots of
Franck's Lab Inc
dba Trinity
Shamrock
Medical
Solutions
Group LLC
57
Product
Type
Product Description
Code info.
Class
Drugs
Vancomycin 750 mg/100
mL 0.9%NS, For
Parenteral Use Only, Rx #
28289, Discard After
02/5/14; Rx # 29189,
Discard After 05/23/14
Rx # 28289, Exp
02/5/14; Rx #
29189, Exp
05/23/14
Class II
Drugs
Pfizerpen (penicillin G) 24
MU/300 mL 0.9%NS, For
05/21/14
Rx 29183 Exp,
5/21/2014
Class II
Drugs
Desferal 2.5 gm/14 mL
Sterile Water, Rx #
05/22/14
Rx 28314 Exp
5/22/2014
Class II
Solutions, 202-C SW 17th
Street, Ocala, FL 344715138, For Parenteral Use
Only, Rx #29184, Discard
After 05/28/14
Reason for Recall
Recalling firm
sterile products
compounded by the
pharmacy within
expiry are subject to
this recall. This recall
is initiated due to
concerns associated
with quality control
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
58
Product
Type
Product Description
Code info.
Drugs
Cefepime 2 gm/100 mL
D5W, For Parenteral Use
Only, Rx # 28288, Discard
After 02/4/14; Rx #
05/21/14; Rx # 28829,
Rx # 28288, Exp
02/4/14; Rx #
29176, Exp
05/21/14; Rx #
28829, Exp
05/17/14
Class II
Drugs
Ceftriaxone 2 gm/100 mL
0.9%NS, For Parenteral
Use Only, RX # 29038,
Discard After 05/05/14,
& 05/20/14; RX # 29204,
Discard After 05/23/14;
RX # 29161, Discard After
05/19/14
Rx # 29039, Exp
05/05/14 &
05/20/14; Rx #
29204, Exp
05/23/14; Rx #
29161, Exp
05/19/14
Class II
Drugs
Cubicin 486 mg/100 mL
Use Only, RX # 29038,
Rx # 29038, Exp
05/20/14
Class II
Class
Reason for Recall
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
Recalling firm
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
59
Product
Type
Drugs
Product Description
Code info.
Invanz (ertapenem)1
gm/100 mL 0.9%NS, For
05/19/14; Rx # 29097,
Rx # 29157, Exp
5/19/14; Rx #
29097, Exp
5/20/14
Class II
Drugs
Meropenem 1 gm/100
mL 0.9%NS, For
05/28/14
Rx # 29087 Exp.
5/28/2014
Class II
Drugs
Nafcillin 12 gm/300 mL,
For Parenteral Use Only,
Rx # 29162, Discard After
05/21/14
Rx 29162 Exp.
5/21/2014
Class II
Drugs
Unasyn
(ampicillin/sulbactam)
1.5 gm/100 mL 0.9%NS,
For Parenteral Use Only,
05/19/14
Rx # 29082 Exp.
5/19/14
Class II
Class
Reason for Recall
Recalling firm
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
60
Product
Type
Product Description
Code info.
Drugs
Desferal 2 gm/8 mL
Sterile Water, For
05/23/14
Rx # 27767, Exp
05/23/14
Class II
Drugs
Impipenem/Cilastin
(Primaxin) 500 mg/100
mL 0.9%NS, For
Parenteral Use Only, Rx
#28694, Discard After
05/22/14
Rx #28694, Exp
05/22/14
Class II
Drugs
Cefazolin 1 gm/100 mL
Use Only, Rx # 28837,
Rx # 28837, Exp
04/11/14
Class II
Class
Reason for Recall
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
Recalling firm
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
61
Product
Type
Product Description
Code info.
Drugs
Rx # 29114, Exp
05/13/14
Class II
Drugs
Normal Saline 10 mL/10
mL Syringe, Rx # 28839,
Discard After 05/5/15; Rx
# 29163, Discard After
05/8/15
Rx # 28839, Exp
05/5/15; Rx #
29136, Exp
05/8/15
Class II
Drugs
Ambisome 285 mg/250
mL D5W, For Parenteral
Rx # 28300, Exp
02/7/14
Class II
Drugs
ANA Kit, For Parenteral
Rx # 28838, Exp
03/4/15
Class II
Class
Reason for Recall
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
Recalling firm
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
62
Product
Type
Product Description
Code info.
Drugs
Tobramycin 300 mg/7.5
mL Syringe (for Neb), For
02/27/14
Rx # 28503, Exp
02/27/14
Class II
Drugs
Vancomycin 1 gm/100
mL 0.9%NS, For
05/22/14; Rx # 29010,
Rx # 29186, Exp
05/22/14; Rx #
29010, Exp
05/22/14
Class II
Drugs
Vancomycin 1.25 gm/250
mL 0.9%NS, For
05/23/14
Rx # 29140, Exp
05/23/14
Class II
Class
Reason for Recall
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
Recalling firm
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
63
Product
Type
Product Description
Code info.
Drugs
Vancomycin 750
mg/150mL D5W, For
05/16/14
Rx # 28878, Exp
05/16/14
Class II
Drugs
Vancomycin 1.25 gm/100
mL 0.9%NS, For
05/23/14
Rx # 29185, Exp
05/23/14
Class II
Drugs
Discard After 05/21/14;
05/17/14
Rx # 29175, Exp
05/21/14; Rx #
28830, Exp
05/17/14
Class II
Drugs
Rx # 29096, Exp
05/20/14
Class II
Class
Reason for Recall
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
Recalling firm
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
64
Product
Type
Product Description
Code info.
Class
Drugs
Rx # 29083, Exp
05/21/14
Class II
Drugs
Discard After 05/21/14,
05/22/14, Rx # 29171,
Rx # 29011, Exp
05/21/14; Rx #
29141, Exp
05/22/14; Rx #
29171, Exp
05/20/14
Class II
Drugs
After 05/17/14
Rx # 29150, Exp
05/17/14
Class II
Reason for Recall
Recalling firm
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
65
Product
Type
Product Description
Code info.
Drugs
Rx # 28879, Exp
05/21/14
Class II
Drugs
After 05/23/14, Rx #
29068, Exp 05/18/14
Rx # 29190, Exp
05/23/14; Rx #
29068, Exp
05/18/14
Class II
Drugs
Hemo-Stat Solution,
Aluminum chloride 25%,
in 37.2 g glass bottles
G12069 July
2014 H12087
August 2014
H12089 August
2014 L12161
December 2014
D13076 April
2015 G13120
July 2015
I13145
September 2015
J13165 October
2015 J13166
October 2015
Class II
Class
Reason for Recall
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
sterile products
compounded by the
pharmacy within
is initiated due to
concerns associated
procedures observed
during a recent FDA
inspection.
Marketed without an
Approved
NDA/ANDA; product
is being
manufactured and
distributed without a
NDC number
Recalling firm
Franck's Lab Inc
dba Trinity
Care Solutions
Franck's Lab Inc
dba Trinity
Care Solutions
Axcentria
Pharmaceutical
s, LLC
66
Product
Type
Drugs
Drugs
Drugs
Product Description
Code info.
ChloraPrep With Tint, 2%
w/v chlorhexidine
gluconate (CHG) and 70%
v/v isopropyl alcohol
(IPA), 26 mL APPLICATOR,
Hi-Lite Orange. Rx Only.
NDC: 054365-400-13.
Fentanyl Citrate
Injection, USP, 2500 mcg
Fentanyl/50 mL, C-II, (50
mcg/mL), 50 mL Singledose Fliptop Vial, Rx only.
NDC: 0409-9094-61.
Tyvaso (treprostinil)
Inhalation Solution,
Treprostinil 1.74 mg/2.9
mL, Four 2.9 mL
Ampules, For Oral
Inhalation Use Only
Lot #: 71132,
Expiry: 02/2017
Class II
CareFusion
Sterility; Immediate
213, LLC
product pouches may
not be properly
sealed.
Lot #: 39474DK,
Expiry:
03/01/2016.
Class II
Sterility: Fliptop vial
crimps are loose or
missing.
Hospira Inc.
Lot #s: TD-100:
PCBA Lot 60 TD100: PCBA Lot
61 TD-100:
PCBA Lot 62 TD100: PCBA Lot
63 Optineb:
PCBA Lot 72
Optineb: PCBA
Lot 73 SERIAL
NUMBERS: Kit
S/N ML 1897 ML
1898 ML 1894
ML 1895 ML
1896 TD-100
S/N's 23103954
23103976
23104015
23104017
23104006
23104000
23103995
23104018
23104016
Optineb devices
shipped to
Caremark: Kit
S/N ML 3660
MP 3662 ML
3665 MP 3667
MP 3668 MP
3676 MP 3683
Class II
Defective Delivery
System: United
Therapeutics is
voluntarily recalling a
small number of
Tyvaso Inhalation
Systems with
Optineb ON-100/7
and TD-100/A
medical devices.
These devices may
have been
programmed with a
different software
version than
intended for the
device. If the device
has the incorrect
software, it may not
operate as indicated
in the Instructions for
Use.
United
Therapeutics
Corp.
Class
Reason for Recall
Recalling firm
67
Product
Type
Product Description
Code info.
Class
Reason for Recall
Recalling firm
MP 3690 ML
3691 MP 3692
Optineb S/N's
20900207
20900212
20900219
20900222
20900226
20900209
20900213
20900225
20900227
20900241
20900310
20900295
20900293
20900291
20900240
20900308
20900294
20900292
20900290 Kit
S/N 3697 MP
3698 ML 3699
MP 3700 MP
3708 MP
Optineb S/N's
20900262
20900283
20900285
20900265
20900253
20900264
20900284
20900286
20900268
20900315 NPR
Device Not Part
of Recall
MP=Mount
Prospect; MLMonroeville TD100 devices
shipped to
Accredo: Kit S/N
68
Product
Type
Product Description
Drugs
Fosphenytoin Sodium
Injection, USP, 100 mg
PE/2 mL (50 mg PE/mL)
(PE= phenytoin sodium
equivalents) 2 mL Single
Use Vial, Rx only, NDC
63323-403-02
Code info.
1879 1880 1881
1882 1883 1884
1885 1886 1887
TD-100 S/N's
23103982
23103985
23103988
23103990
23103992
23103984
23103986
23103989
23103991
23103993
23103959
23103961
23103963
23103994
23103958
23103960
23103962
23103972 Kit
S/N 1888 1889
1890 1891 1892
1893 1899 1900
1901 TD-100 ...
Lot # 6003850;
04/14 6003926;
05/14 6004052;
05/14 6004053;
05/14 6004093;
06/14 6004094;
06/14 6004199;
07/14 6004200;
07/14 6004509;
08/14 6004510;
08/14 6004661;
09/14 6005157;
11/14 6005158;
11/14 6005197;
11/14 6005198;
11/14 6005446;
01/15 6005447;
01/15 6005702;
03/15 6005703;
Class
Class II
Reason for Recall
Recalling firm
Presence of
Fresenius Kabi
Particular Matter:
USA, LLC
Potential glass
delamination and
consistent with glass
particulates observed
in sample vials.
69
Product
Type
Product Description
Drugs
Fosphenytoin Sodium
Injection, USP, 500 mg
PE/10 mL (50 mg PE/mL),
(PE= phenytoin sodium
equivalents) 10 mL Single
Use Vial, Rx only, NDC
63323-403-10
Drugs
Labetalol Hydrochloride
Injection, USP, 100
mg/20 mL (5 mg/mL), 20
mL Multidose Vial,
Code info.
03/15 6005790;
03/15 6005791;
03/15 6006005;
05/15 6006006;
05/15 6006091;
05/15 6006211;
06/15 6006212;
06/15 6006396;
07/15 6006397;
07/15
Lot # 6003854;
04/14 6003855;
04/14 6004011;
05/14 6003961;
05/14 6004091;
06/14 6004092;
06/14 6004553;
08/14 6004554;
08/14 6004588;
09/14 6004589;
09/14 6005201;
12/14 6005202;
12/14 6005293;
12/14 6005294;
12/14 6005545;
02/15 6005546;
02/15 6005831;
03/15 6005832;
03/15 6005973;
04/15 6005974;
04/15 6006035;
05/15 6006036;
05/15 6006037;
05/15 6006174;
05/15 6006175;
05/15 6006176;
06/15 6006449;
07/15 6006450;
07/15 6006451;
07/15 6007168;
11/15
Lot 36225DD,
exp 12/01/2015
Class
Reason for Recall
Recalling firm
Class II
Presence of
Fresenius Kabi
Particular Matter:
USA, LLC
Potential glass
delamination and
consistent with glass
particulates observed
in sample vials.
Class II
Presence of
Particulate Matter;
metal embedded in
the glass vial and
Hospira Inc.
70
Product
Type
Product Description
Code info.
Class
packaged 50/20 mL glass
vials/carton, NDC 04092267-20
BUPivacaine HCl 0.25%
Preservative Free (2.5
mg/mL) 500 mL in On-Q
C-bloc (2-14 mL/hr) bag,
NDC 75901-7210-53.
Lot #: 6156-0,
Exp 03/07/14
Class II
Drugs
Calcitriol Oral Solution 1
mcg/mL, 15mL bottle, Rx
only, NDC 0054-3120-41.
Lot # 360122A,
EXP Date: MAY
2015
Class II
Drugs
Fluvastatin Capsules USP,
20 mg, Rx Only, 30-count
bottle, NDC 0093-744256
Lot #: F47008,
Exp. 7/2015
Class II
Drugs
Heparin Sodium in 5%
Dextrose Injection,
Heparin, 25,000 USP
Heparin Units/250 mL
(100 USP Heparin
Units/mL), 250 mL,
Single-Dose Container,
NDC 0409-7793-62
Lot # 34-811-KL,
36-106-KL, 36114-KL; Exp.
12/15; 36-101KL, Exp. 12/15;
37-202-KL, Exp.
1/16; 38-302-KL,
Exp. 2/16; 38305-KL, Exp.
Class II
Drugs
Reason for Recall
visible particles
floating in the
solution
Presence of
Particulate Matter:
The bupivacaine HCl
injection used to
compound this lot of
BUPivacaine HCl
0.25% Preservative
Free 500 mL in On-Q
C-bloc was recalled
by the supplier due
to a customer
complaint of visible
particles embedded
in the glass vial.
Failed
Impurity/Degradatio
n Specification; out
of specification for
trans-calcitriol
degradant at the 9
month stability time
point
Specifications: Teva
Pharmaceuticals USA,
Inc. is voluntarily
recalling one lot of
Fluvastatin Capsules
USP, 20 mg due to a
customer complaint
trend regarding
capsule breakage.
Sterility: Confirmed
consumer report of
fluid leaking from
primary container of
bag.
Recalling firm
Healix Infusion
Therapy, Inc.
Boehringer
Ingelheim
Roxane Inc
Teva
Pharmaceutical
s USA
Hospira Inc.
71
Product
Type
Product Description
Drugs
Isoniazid Tablets, USP,
300 mg, Rx only,
packaged in a) 100-count
bottles, NDC 0143-126101, b) 1000-count
bottles, NDC 0143-126110, c) 30-count bottles,
NDC 61748-013-30, d)
100-count bottles, NDC
61748-013-01, e) 1000count bottles, NDC
61748-013-10
Drugs
Bystolic (nebivolol)
tablets, 20 mg/tablet. 7
Tablet Professional
Sample Bottle, Rx Only.
NDC 0456-1420-07.
Brevibloc Premixed
Injection, Esmolol
Hydrochloride in Sodium
Chloride, 2,500 mg/250
mL (10 mg/mL), 250 mL
Single Use IntraVia
container, packaged in 10
x 250 mL Single Use
IntraVia containers per
carton, Rx only , Product
Code 2J1415, NDC
10019-055-61.
Mometasone 0.6 mg /60
mL Irrigation solution,
4000 mL bottle, Rx only
Drugs
Drugs
Drugs
Diphenhydramine
(Alcohol Base) 25 mg /
0.5 mL Solution, 30 mL
bottle, Rx only
Code info.
Reason for Recall
Recalling firm
Class II
Failed Dissolution
Specifications:
Stability lots cannot
support dissolution
past the 36 month
time point.
West-Ward
Pharmaceutical
Corp.
Class II
Failed Dissolution
Specifications: Drug
failed stage III
dissolution testing.
Forest
Pharmaceutical
s Inc
Lot #: C926923,
Exp 01/16
Class II
Presence of
Particulate Matter:
Complaints received
of discolored solution
identified as
subvisible particles of
iron oxide that are
agglomerating.
Baxter
Healthcare
Corp.
Lot # / Beyond
Use Date:
04282014@11 /
BUD 05/28/14;
04212014@4 /
BUD
05/21/2014
Lot # / Beyond
Use Date:
05012014@36 /
05/15/14
Class II
Incorrect/Undeclared
Excipients: Specific
drug products were
compounded with an
incorrect solvent.
Brookfield
Prescription
Center Inc. dba
MD Custom Rx
Class II
drug products were
compounded with an
Brookfield
Prescription
Center Inc. dba
MD Custom Rx
2/16
Lot #: a)
67839A,
67839D, Exp
05/14; 67936A,
Exp 02/15; b)
67839B,
67840C, Exp
05/14; 67936B,
Exp 02/15; c)
67840A, Exp
05/14; d)
67840B, Exp
05/14; e)
67839C, Exp
05/14
Lot # A308879,
Expiry: 09/2015
Class
72
Product
Type
Product Description
Drugs
HCG (Human Chorionic
Gonadotropin) 125 units/
0.1 mL drop, 5 mL bottle,
Rx only
Drugs
HCG 125U/Tab Tablet
Tritu, 50 tablets per
bottle, Rx only
Drugs
Gonadotropin) 200 units/
0.1 mL drops, packaged
in 5 mL and 10 mL
bottles, Rx only
Drugs
Gonadotropin) +
Methylcobalamin
(Methyl B12), 1500 units
Code info.
Lot # / Beyond
Use Date:
05192014@15 /
BUD 07/18/14;
04142014@39 /
BUD 6-13-14;
04182014@4 /
BUD 6-17-14;
04162014@12 /
BUD 06/15/14;
05092014@34 /
BUD 07/08/14;
04162014@35 /
BUD 06/15/14;
05232014@33 /
BUD 07/22/14;
05022014@36 /
BUD 7/1/14; ...
More
Lot # / Beyond
Use Date:
05022014@5 /
BUD 07/01/14;
04032014@7 ...
More
Lot # / Beyond
Use Date:
04232014@49 /
BUD 06-22-14;
04232014@2 /
BUD 06/22/14;
04252014@27 /
BUD 06/24/14;
04162014@33 /
BUD06/15/14;
05132014@2 /
BUD 07/12/14;
05092014@39
BUD 7-8-14
Lot # / Beyond
Use Date:
04302014@21 /
BUD 06/29/14
Class
Class II
Reason for Recall
Recalling firm
incorrect solvent.
drug products were
compounded with an
incorrect solvent.
Brookfield
Prescription
Center Inc. dba
MD Custom Rx
Class II
drug products were
compounded with an
incorrect solvent.
Brookfield
Prescription
Center Inc. dba
MD Custom Rx
Class II
drug products were
compounded with an
incorrect solvent.
Brookfield
Prescription
Center Inc. dba
MD Custom Rx
Class II
drug products were
compounded with an
Brookfield
Prescription
Center Inc. dba
MD Custom Rx
73
Product
Type
Drugs
Product Description
+ 1000 mcg/mL drop, 8
mL bottle, Rx only
Venlafaxine
Hydrochloride ExtendedRelease Tablets, 150 mg,
Rx only, Packaged in 30
Count and 90 Count
Bottles. 30-Count Bottle
NDC: 41616-758-83, 90Count Bottle: NDC
41616-758-81.
Code info.
Class
Reason for Recall
Recalling firm
incorrect solvent.
30 Count Bottle:
Lot #: JKL5054A,
Expiry: 08/2014;
Lot #:
JKM2305A,
Expiry: 03/2015.
90 Count Bottle:
Lot #: JKL5054B,
Expiry: 08/2014;
Lot #:
JKM2305B,
Expiry: 03/2015.
Class II
Drugs
Pristiq (desvenlafaxine)
Extended-Release Tablets
50 mg, 30 count bottle,
Rx only, NDC 0008-121130
Drugs
Gemcitabine For
Injection USP, 1 g,
(lyophilized), For
Intravenous Use Only,
Sterile Single Use Vial, Rx
only, NDC 47335-154-40
Drugs
Dextroamphetamine
Lot #
Sulfate Tablets, USP, 10
34013122A, Exp
mg, 100-count bottles, Rx
11/15
only, NDC 0555-0953-02.
Class II
Drugs
Muro 128 (sodium
chloride) hypertonicity
ophthalmic ointment,
Class II
H74477,
H74478, Exp.
03/16, H74479,
H79766 Exp.
05/16
JKM7188A
Lot #: a)
179271, Exp
08/14; b) and c)
Class II
Class II
Failed Dissolution
Specifications:
Stability results
found the product
did not meet the
drug release
dissolution
specifications.
Presence of Foreign
Tablets/Capsules:
Pfizer is recalling 50
mg Pristiq
(desvenlafaxine)
extended release
tablets because a
single Pristiq 100 mg
tablet was found in a
bottle of 50 mg
Pristiq.
Sterility: A particle
excursion for a
different batch of the
same product may
lead to a lack of
sterility assurance.
Failed
on Specifications: this
product is being
recalled due to an
test result for
impurities during
stability testing.
Crystallization:
Crystal precipitate
formation and an
Caraco
Pharmaceutical
Laboratories,
Ltd.
Pfizer Us
Pharmaceutical
Group
Caraco
Pharmaceutical
Laboratories,
Ltd.
Teva
Pharmaceutical
s USA
Bausch &
Lomb, Inc.
74
Product
Type
Product Description
Code info.
5%, packaged in a) 1 g
tube per carton,
professional sample, NDC
24208-385-01, UPC 3
24208-385-01 2; b) 1/8
oz. (3.5 g) tube per
carton, NDC 24208-38555, UPC 3 24208-385-55
5; and c) 1/4 oz. (7 g)
Twin Pack, Two 1/8 oz.
(3.5 g) tubes per carton,
NDC 24208-385-56, UPC
3 24208-385-563
146791,
146932, ...
More
Sodium Chloride
Hypertonicity Ophthalmic
Ointment, 5%, 1/8 oz.
(3.5 g) tube per carton,
NDC 0904-5315-38, UPC
3 09045 31538 5.
Lot #'s: 159101,
Exp 02/15;
169271, Exp
09/15; and
170481, Exp
10/15
Class II
Drugs
Captomer [succinic acid
(from 100 mg DMSA)]
capsules, 65 mg, 45count bottles, UPC 6
93749 74002 5
All lot codes
Class II
Drugs
Captomer-250 [succinic
acid (from 250 mg
DMSA)] capsules, 162
mg, 45-count bottles,
UPC 6 93749 73502 1
All lot codes
Class II
Drugs
Class
Reason for Recall
Recalling firm
increase in the
number of
complaints
associated with a
gritty, sand-like
feeling in the eye.
Crystallization:
Crystal precipitate
formation and an
increase in the
number of
complaints
associated with a
gritty, sand-like
feeling in the eye.
Marketed Without
An Approved
NDA/ANDA:
Captomer and
Captomer-250 are
marketed as dietary
supplements and
labeled to be sourced
from
Dimercaptosuccinic
Acid (DMSA) which is
the active ingredient
in an FDA approved
drug making these
products unapproved
new drugs.
Marketed Without
An Approved
NDA/ANDA:
Captomer and
Captomer-250 are
marketed as dietary
supplements and
Bausch &
Lomb, Inc.
Thorne
Research Inc
Thorne
Research Inc
75
Product
Type
Product Description
Drugs
TEV-TROPIN [somatropin
(rDNA origin) for
injection] 5 mg (15 IU) 1count bottle, Rx Only,
NDC 57844-713-46
Drugs
Vancomycin
Hydrochloride Capsules,
USP, 250 mg. 20 Capsules
on 2 x 10 Capsule Blister
Cards, Rx Only. NDC
0591-3561-15.
Polidocanol 0.5%
Solution for Injection,
Polidocanol (Laureth 9)
5mg, 50 mL
Drugs
Drugs
Liver Derivative Complex
for injection, each mL
contains: Liver Derivative
Complex 25.5mg, also
contains: Water for
Injection, Phenol 0.5%,
HCl or NaOH to adjust
Code info.
Class
Reason for Recall
Recalling firm
Class II
labeled to be sourced
from
Dimercaptosuccinic
Acid (DMSA) which is
the active ingredient
in an FDA approved
drug making these
products unapproved
new drugs.
Chemical
Contamination: TEVTROPIN [somatropin
(rDNA origin) for
injection] may
contain silicone oil
due to leakage of a
leaking line during
the freeze-drying
process.
Class II
Subpotent Drug.
Actavis Inc
Lot 563.61, use
by 05/31/14;
Lot 2616, Use by
3/31/15
Class II
John W Hollis
Inc
Lot# 938, Use by
08/17/14, Lot
#1370; Use by
Lot# 1818; Use
by 11/08/14,
1/30/15; Lot#
2664, Use by
Class II
Sterility: Lack of
sterility assurance in
compounded
aseptically filled
injectable products.
Sterility: Lack of
compounded
aseptically filled
Lot # H11599A;
Exp. 03/16 Lot #
H11599B; Exp.
03/16 Lot #
H12913A; Exp.
05/16 Lot #
H12913B; Exp.
05/16 Lot #
H12914A; Exp.
05/16 Lot #
H12914B; Exp.
05/16 Lot #
H13846A; Exp.
07/16 Lot #
H13846B; Exp.
07/16
Lot #: 3100135,
Expiry: 05/2014
Ferring
Pharmaceutical
s Inc
John W Hollis
Inc
76
Product
Type
Drugs
Drugs
Drugs
Drugs
Drugs
Product Description
Code info.
pH, 10 mL
CYANOCOBALAMIN FOR
INTRAMUSCULAR OR
SUBCUTANEOUS USE
ONLY, Each mL contains:
Cyanocobalamin 1000
mcg, , Also Contains:
Benzyl Alcohol, Sodium
Chloride, Water,
Hydrochloric Acid, and/or
Sodium Hydroxide, 30 mL
4/18/15
Lot # 940, Best
used by
08/01/14; Lot #
1090, Best used
by 08/29/14;
Lot # 1533, Best
used by
05/24/14; Lot #
1838, Best used
by 07/15/14;
Lot# 2755, Best
used by
10/06/14
Polidocanol 5% Solution
Lot 1076, use by
for Injection, each mL
08/28/14; Lot
contains Polidocanol
2410, use by
(Laureth 9) 50 mg, also
09/13/14; Lot
contains Sterile Water for 2746, use by
Injection, Ethyl Alcohol,
10/06/14
Anhydrous
Chlorobutanol, 50 mL
Vial
Testosterone Cypionate
lot# 1157, Use
by 09/16/14;
contains Testosterone
lot# 2357, use
Cypionate 200 mg, also
by 06/01/14
contains: Cotton Seed
Oil, Benzyl Benzoate,
Benzyl Alcohol, Rx Only,
10 mL
MIC PLUS B12,
Lot 1507, Use by
Adenosine, L-Carnitine,
5/18/14; Lot
Contains: Methionine
1863, Use by
15mg, Choline 100mg,
7/20/14
Inositol 50mg, B 12,
0.200mg, Adenosine
20mg, L-Carnitine
30mg/ML, 30ML MULTI
DOSE VIAL, BENZYL
ALCOHOL AS A
PRESERVATIVE
Mannitol 5% Solution for Lot 1507, Use by
injection, Mannitol 50
5/18/14; Lot
Class
Reason for Recall
Recalling firm
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
John W Hollis
Inc
77
Product
Type
Drugs
Drugs
Drugs
Drugs
Product Description
Code info.
mg, also contains Sterile
Water for Injection,
Chlorobutanol USP, 50
mL
Levocarnitine Solution
for injection, l-Carnitine
50 mg, Also Contains
Sterile Water for
Injection and Benzyl
Alcohol pH adjusted with
HCl, 50 mL
METHYLCOBALAMIN FOR
INTRAMUSCULAR OR
SUBCUTANEOUS USE
ONLY, Methylcobalamin
1000 mcg, Also Contains:
Benzyl Alcohol, Sodium
Chloride, Water,
Papaverine HCl 30 mg,
Phentolamine Mesylate 1
mg, Alprostadil 20 mcg,
a) 5 mL and b) 10 mL
1863, Use by
7/20/14
B-Complex/Adenosine Inj
sol, Adenosine-5Monophosphate 0.03g,
Choline Chloride 0.01g,
Cyanocobalamin 0.3mg,
Inositol 0.05g,
Class
Reason for Recall
Recalling firm
compounded
aseptically filled
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Lot: 1731, Use
by 7/01/14; Lot:
2190, Use by
8/24/14
Class II
Lot # 1862, used
by 7/20/14
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
a) 5 mL: Lot:
2319, best used
by 6/04/14; Lot:
2510, best used
by 6/22/14; Lot:
2576, best used
by 6/25/14; Lot:
2624, best by
6/30/14; Lot:
2744, best used
by 7/08/14; Lot:
3048, best used
by 7/30/14; Lot:
3062, best used
by 7/31/14; Lot:
3106, best used
by 8/6/14; ...
More
Lot # 2095, Use
by 8/17/14
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
78
Product
Type
Drugs
Product Description
Methionine 0.015g,
Levocarnitine 0.1g,
Chromic Chloride 0.15g,
Lidocaine HCl 0.01g,
Pyrodoxine HCl 0.005g,
30 mL
Drugs
mg, a) 5 mL and b) 10 mL
Drugs
10 mL
Drugs
Phentolamine Mesylate
Code info.
Class
Reason for Recall
Recalling firm
a) 5 mL: Lot:
2543, best used
by 3/24/14; Lot:
2137, best used
by 5/25/14; Lot
3056, best used
by 7/30/14; Lot:
3081, best used
by 8/04/14; b)
10 mL: Lot:
2194, best used
by 5/26/14; Lot:
2950, best used
by 7/22/14
a) 5 mL: Lot:
2297, best used
by 6/04/14; Lot:
2578, best used
by 6/25/14; Lot:
2672, best used
by 7/03/14; Lot:
3022, best used
by 7/28/14; b)
10 mL: Lot:
2166, best used
by 5/26/14; Lot:
2297, best used
by 6/04/14; Lot:
2578, best used
by 6/25/14
Lot: 2187, best
used by
05/26/14
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
John W Hollis
Inc
a) 5 mL: Lot:
2488, best used
Class II
Sterility: Lack of
compounded
aseptically filled
Sterility: Lack of
John W Hollis
Inc
79
Product
Type
Product Description
Code info.
0.5 mg, Alprostadil 10
mcg, a) 5 mL and b) 10
mL
Drugs
Drugs
LIPOTROPIC GOLD, Each
mL contains:
Levocarnitine 5 mg,
Thiamine 50 mg,
Riboflavin-5 phosphate
5mg, Niacinimide 50mg,
Calcium Pantothenate 5
mg, Cyanocobalamin
1mg, Methionine
12.5mg, Choline 25mg,
Inositol 25 mg, Sterile
Water For injection
PYRIDOXINE HCL,
Pyridoxine HCl 100mg,
Also Contans: Benzyl
Alcohol, Sodium
Chloride, Water,
Polidocanol 1% Solution
contains Polidocanol
(Laureth 9) 10 mg, also
contains Sterile Water for
Injection, Ethyl Alcohol,
by 6/19/14; b)
10 mL: Lot:
2264, best used
by 06/03/14;
Lot: 2295, best
used by
06/04/14
a) 5 mL: Lot:
2670 best used
by 7/02/14; Lot
2855, best used
by 7/15/14; b)
10 mL: Lot:
2303, best used
by 6/04/14; Lot:
2343, best used
by 6/08/14; Lot:
2600, best used
by 6/29/14;
lot: 2571, use by
9/23/14
Drugs
Drugs
Class
Reason for Recall
Recalling firm
compounded
aseptically filled
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Lot: 2789, Best
used by:
7/10/14
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
Lot 2868, Best
used by 3/15/15
Class II
Sterility: Lack of
compounded
aseptically filled
John W Hollis
Inc
80
Product
Type
Drugs
Drugs
Drugs
Product Description
Anhydrous
Chlorobutanol, 50 mL
Foradil Aerolizer
(formoterol fumarate
inhalation powder), 12
mcg per capsule, 60
Capsules, Rx only, NDC
0085-1401-01
ENDOMETRIN
(progesterone) Vaginal
Insert 100 mg USP, 21
inserts, Rx Only, NDC
55566-6500-3
Apri (desogestrel and
ethinyl estradiol tablets
USP), 0.15 mg/0.03 mg, 6
Cyclic dispensers X 28
tablets, Rx only, NDC
0555-9043-58
Code info.
Class
Reason for Recall
Recalling firm
Lot F0067 exp.
06/14, F0079
exp. 04/15
Class III
Novartis
Pharmaceutical
s Corp.
Lot
Number:Expiry
Date 0804.182B1:07/14;
0804.183B1:07/14;
0804.185A1:08/14;
0804.186B1:08/14;
0804.187B1:08/14;
0804.210A1:12/14;
0804.212A1:12/14;
0804.213A1:12/14;
0804.214A1:12/14;
0804.216B1:12/14;
0804.223B1:02/15
0804.225B1:03/15
Lot 3805324A
Exp. 11/14
Class III
Failed Content
Uniformity
Specification; out of
specification results
for particle size
distribution
Discoloration; due to
prolonged heat
exposure.
Class III
Ferring
Pharmaceutical
s Inc
Failed
Teva
Impurities/Degradati Pharmaceutical
on Specifications:
s USA
Teva Pharmaceuticals
USA, Inc. is
voluntarily recalling
one lot of Aprif
tablets due to out of
specification impurity
test results.
81
Product
Type
Drugs
Product Description
Code info.
Class
Reason for Recall
Recalling firm
Mircette
(desogestrel/ethinyl
estradiol and ethinyl
estradiol) Tablets 0.15
mg/0.02 mg and 0.01 mg,
6 Cyclic dispensers X 28
51285-114-58
Lot 33805507A,
Exp. date 11/14
Class III
Teva
Pharmaceutical
s USA
Drugs
Kariva
(desogestrel/ethinyl
estradiol and ethinyl
estradiol) Tablets 0.15
mg/0.02 mg and 0.01 mg,
6 Cyclic dispensers X 28
0555-9050-58
Lot 33805325A,
Exp.11/14
Class III
Drugs
Velivet (desogestrel and
ethinyl estradiol tablets triphasic regimen), 0.1
mg/0.025 mg; 0.125
mg/0.025 mg; 0.15
mg/0.025 mg, 3
Dispensers x 28 Tablets,
NDC 0555-9051-67
Lot 33805449A,
Exp. 12/14
Class III
Drugs
VIRACEPT (R) (nelfinavir
mesylate) Tablets, 625
mg, 120-count bottle, Rx
only,NDC 63010-027-70
Lot H45241,
exp. 11/16
Class III
Drugs
POLY-TUSSIN AC LIQUID,
Each 5 mL (1
teaspoonful) contains:
Brompheniramine
Lot #: 04413,
Expiry: 02/15
Class III
Failed
on Specifications:
USA, Inc. is
one lot of Mircette
test results.
Failed
on Specifications:
USA, Inc. is
one lot of Kariva
test results.
Failed
on Specifications:
USA, Inc. is
one lot of Velivet
distributed by Barr
Laboratories, Inc. due
to out of
test results.
Labeling: Incorrect or
missing lot and or
Exp Date: The bottles
were labeled with an
incorrect expiry date
11/2016. The correct
expiry date is
09/2016.
Does Not Meet
Monograph:
Phenylephrine and
pseudoephedrine are
Teva
Pharmaceutical
s USA
Teva
Pharmaceutical
s USA
Pfizer Inc.
Poly
Pharmaceutical
s, Inc
82
Product
Type
Drugs
Product Description
Maleate 4 mg, Codeine
Phosphate 10 mg,
Phenylephrine HCl 7.5
mg, 16 fl oz. (473 mL)
Bottle, Rx Only, NDC:
50991-713-16.
LORTUSS EX, Each 5 mL
(1 teaspoonful) contains:
Codeine Phosphate 10
mg, Guaifenesin 100 mg,
Psuedoephedrine HCl
22.5 mg, 16 fl oz. (473
mL), Rx Only. NDC:
50991-515-16.
Code info.
Class
Reason for Recall
Recalling firm
below monograph
specifications, and
label inaccurately
contains wording "Rx
Only".
Lot #: 03613,
Expiry: 02/15
Class III
Lot(s): 497R,
498R, Exp
01/2015; 635R,
636R, Exp
03/2015; 850R,
Exp 04/2015;
073S, Exp
05/2015; 074S,
Exp 06/2015.
Lot: 849R, Exp
04/2015
Class III
Drugs
Triamcinolone Acetonide
Lotion USP, 0.1%, 60 mL
Bottle, Rx Only, For
Dermatologic Use Only,
Not for Ophthalmic Use,
NDC 0168-0337-60.
Drugs
Triamcinolone Acetonide
Lotion USP, 0.025%, 60
mL Bottle, Rx Only, For
Dermatologic Use Only,
Not for Ophthalmic Use,
NDC 0168-0336-60.
Drugs
Diltiazem HCl Extendedrelease Capsules, USP,
120 mg, packaged in 80
Capsules (8 x 10) blister
cards per carton, Rx only,
NDC 51079-947-08.
Lot #: 3045659,
3048256, Exp
07/14
Class III
Drugs
DENBLAN Anticavity
Fluoride Toothpaste,
Whitening formula,
sodium
All lot codes and
shipment dates
are being
recalled.
Class III
Class III
Does Not Meet
Monograph:
Phenylephrine and
pseudoephedrine are
below monograph
specifications, and
label inaccurately
contains wording "Rx
Only".
Failed PH
Specifications: It has
been determined
that the pH of the
lots recalled, may not
meet specification at
expiry.
Poly
Pharmaceutical
s, Inc
Failed PH
Specifications: It has
been determined
that the pH of the
lots recalled, may not
meet specification at
expiry.
Failed
on Specifications:
High out-ofspecification results
for a related
compound obtained
during routine
stability testing.
Stability Data Does
Not Support Expiry
Fougera
Pharmaceutical
s Inc.
Fougera
Pharmaceutical
s Inc.
Mylan
Institutional,
Inc. (d.b.a. UDL
Laboratories)
Estee Lauder
Inc
83
Product
Type
Product Description
Code info.
monofluorophosphate
0.76%, 2.6 oz/75 mL tube
Drugs
Clonidine HCl Injection,
1000 mcg/10 mL (100
mcg/mL),10 mL Single
Dose Vial, Rx only, NDC
39822-2000-1.
2.6oz/75ml. in a
light green
carton, UPC: 882381-07901-7
Code: D079-011000
Lot: PLNB1412,
Exp 12/15
Drugs
Orphenadrine Citrate
Extended Release
Tablets, 100 mg a)100count bottle, (NDC 01850022-01) b) 1000-count
bottle, (NDC 0185-002210), Rx only.
Cardura XL (doxazosin
mesylate extended
release tablets, 4 mg, 30count bottle), Rx only,
NDC 0049-2710-30
Drugs
Class
Reason for Recall
Recalling firm
Class III
Labeling: Label Error
On Declared
Strength: The side
label description
incorrectly states
"Each mL contains
500 mcg Clonidine
Hydrochloride"
instead of stating
"Each mL contains
100 mcg Clonidine
Hydrochloride".
Failed Dissolution
Specifications:
Product found to be
(OOS) during stability
testing.
X-Gen
Pharmaceutical
s Inc.
Lot # DM1316;
Exp. 05/16 Lot #
DM1318; Exp.
05/16
Class III
Lot # V130822;
Exp 01/15
Class III
Drugs
Aspirin DR Enteric Coated Lot 0093943
Tablets, USP 325 mg, UD
750 tablets (25x30)
Class III
Drugs
OXYCODONE
HYDROCHLORIDE C II
Oral Solution USP, 5
mg/5 mL, 15 mL Vial, Rx
only. NDC: 0054-0523-41.
buPROPion HCl
Extended-Release
Tablets, USP (SR), 100
Lot #: 360241A,
Expiry: 05/2015.
Class III
Lot #: DN10635,
Exp 01/15;
DM13402,
Class III
Drugs
Failed
on Specifications:
Product from this lot
may not meet
specifications for a
product degradant.
Failed Dissolution
Specification; at the
12 month time
interval.
Failed Stability
Specifications: Out of
specification result
for preservative
sodium benzoate.
Failed
on Products: Out of
Sandoz Inc
Pfizer Inc.
Mckesson
Packaging
Services
Boehringer
Ingelheim
Roxane Inc
Wockhardt Usa
Inc.
84
Product
Type
Product Description
Code info.
mg, 500-count bottle, Rx
Only, NDC 64679-101-07.
Drugs
Cataflam (diclofenac
potassium) tablets, 50
mg, 100-count bottles, Rx
only; NDC 0078-0436-05,
UPC 3 0078-0436-05 2.
DN10247, Exp
11/14; and
DM13449, Exp
07/14
Lot # PKTS, Exp
01/17
Drugs
E-Z-HD (barium sulfate)
For Suspension (98%
w/w), 340 g bottle, Rx
Only, NDC 32909-764-01.
Drugs
Depo-Medrol
(methylprednisolone
acetate injectable
suspension USP), 40 mg/
mL, 1 mL Single-Dose
Vial, Rx only, NDC 00093073-03 DEPO-MEDROL
methylprednisolone
acetate Injectable
Suspension USP, 40 mg
per mL, 1 mL Single-Dose
Vial, Rx ONLY, NDC 00093073-23
Lot #'s: 64205,
64206, 64200,
64201, 64202,
64203, 64204,
64207, 64264,
Exp 05/15;
64265, 64267,
64268, 64270,
64271, Exp
06/15
Lot H43272,
H43265 Exp.
09/14
Class
Class III
Class III
Class III
Reason for Recall
specification levels of
the impurity mchlorobenzoic acid
were observed.
Specifications: Ink
identification had
rubbed off tablets in
transit making them
illegible to
pharmacists and
consumers.
Subpotent Drug: Low
results for both pH
and assay obtained
during routine
stability testing after
36 months.
Failed pH
Specification: A pH
result of 2.9 was
obtained at the 9
month stability test
interval at
25C/60%RH. The
registered
specification for pH is
3.0 - 7.0
Recalling firm
Novartis
Pharmaceutical
s Corp.
Bracco
Diagnostic Inc
Pfizer Inc.
*Please refer to FDA website for further information
http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
85
CURRENT DRUG SHORTAGES
Doxazosin Tablets
May 01, 2014
Reason for the Shortage
•
Teva discontinued all unit-dose presentations in November, 2012.
Article link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=586
Source link: http://www.ashp.org
Dactinomycin Injection
May 07, 2014
•
•
•
Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early
2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories.
Supplies of product that has already been manufactured will continue to be released
until inventory is depleted. Bedford Laboratories has a small number of products
manufactured elsewhere that are not affected by this closure, but dactinomycin is not
one of these products.
Recordati acquired several products from Lundbeck in January 2013 including
Cosmegen.
Cosmegen can be ordered through wholesalers or ASD Healthcare at 1-800-746-6273.
Article link:
86
Mercaptopurine Tablets
May 21, 2014
•
Teva could not provide a reason for the shortage
Article link:
Levocarnitine Injection
May 28, 2014
•
•
•
American Regent has levocarnitine injection on back order due to manufacturing delays.
Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014.
Ben Venue supplies multiple sterile injectable products for Bedford Laboratories.
manufactured elsewhere that are not affected by this closure.
Article link:
Vitamin E Aqueous Oral Solution
May 29, 2014
•
Hospira is changing manufacturing sites from a 3rd party manufacturer to in-house
manufacturing. This has caused a delay in production.
Article link:
87
Vinblastine Injection
May 29, 2014
•
•
manufactured elsewhere that are not affected by this closure.1
Fresenius Kabi (formerly APP) had their product in short supply due to increased
demand for the product and a manufacturing delay.
Article link:
Synthetic Conjugated Estrogen
May 29, 2014
•
•
Teva could not provide a reason for the shortage.
Premarin is not affected by this shortage.
Article link:
Chloramphenicol Sodium Succinate Injection
May 29, 2014
•
•
Fresenius Kabi has chloramphenicol injection on back order due to a raw material
shortage.
Fresenius Kabi is the sole supplier of chloramphenicol injection.
Article link:
88
Ammonium Molybdate Injection
May 29, 2014
•
•
American Regent has ammonium molybdate injection on shortage due to manufacturing
delays.
American Regent is the sole supplier of ammonium molybdate injection.
Article link:
Ascorbic Acid Injection
June 02, 2014
•
•
•
American Regent had temporarily suspended distribution of most drug products in April,
2011.
American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
Hospira has discontinued all presentations of Cenolate injection and all supplies were
depleted as of early-February, 2010.
Article link:
Allopurinol Injection
June 02, 2014
•
89
Article link:
Denileukin Diftitox Injection
June 03, 2014
•
•
Eisai is working to resolve a manufacturing problem.
Eisai is the sole manufacturer of denileukin diftitox
Article link:
Choline Magnesium Trisalicylate
June 03, 2014
•
•
Caraco has discontinued their product. Product was recently seized by US Marshals due
to good manufacturing practice violations (see news release for more information).
Marlex could not provide a reason for their shortage.
Article link:
Reserpine Oral Tablets
June 05, 2014
•
•
Sandoz said the shortage is due to a delay in obtaining raw materials.
There are no other manufacturers of reserpine tablets.
Article link:
90
Methazolamide Tablets
June 05, 2014
•
•
Sandoz cannot provide a reason for the shortage.
Perrigo acquired Neptazane tablets and methazolamide tablets from Fera.
Article link:
Acetazolamide Injection
June 05, 2014
•
Article link:
Intravenous Fat Emulsion
June 06, 2014
•
•
•
•
Hospira recalled several lots of Liposyn II and Liposyn III presentations.
Hospira has discontinued the Liposyn II presentations because the raw material is
unavailable.
Hospira has Liposyn III on shortage due to manufacturing delays.
Baxter had Intralipid presentations on intermittent back order due to increased
demand.
91
Article link:
Naproxen Oral Suspension
June 11, 2014
•
•
•
Roxane discontinued their naproxen oral suspension in June 2013.
Genentech could not provide a reason for the shortage.
Palmetto acquired naproxen 25 mg/mL oral suspension in June 2013.
Article link:
Mesna Injection
June 12, 2014
•
•
Teva has a shortage of mesna injection due to manufacturing delays.
Article link:
Atorvastatin Tablets
June 12, 2014
92
•
•
•
•
In November 2012, Ranbaxy voluntarily recalled 41 lots of atorvastatin tablets due to
possible contamination with very small glass particles. Ranbaxy resumed supply of
atorvastatin tablets in late-March 2013.
Ranbaxy has atorvastatin on shortage due to manufacturing delay.
Apotex and Mylan Institutional could not provide a reason for the shortage.
Watson discontinued all atorvastatin presentations in February 2013.
Article link:
Calcium Acetate Capsules
June 16, 2014
•
•
Fresenius Medical cannot provide a reason for the shortage.
Hawthorne states the reason for the shortage was manufacturing delay.
Article link:
Tesamorelin Injection
June 23, 2014
•
•
•
•
EMD Serono had Egrifta 2 mg vials on shortage due to manufacturing delays.
EMD Serono discontinued Egrifta 1 mg vials in May 2013.
Theratechnologies acquired Egrifta from EMD Serono in the spring of 2014.
Theratechnologies has Egrifta 2 mg vials on shortage due to manufacturing delays. More
information is available in a news release.
Article link:
93
Leuprolide Acetate 14-Day Kit
June 23, 2014
•
•
•
Sandoz states the shortage was due to increased demand.
Sandoz relaunched Leuprolide 1 mg/0.2 mL 2.8 mL injection in late-January, 2013. The
product has a new NDC number.
Teva states the shortage is due to manufacturing delays.
Article link:
Iron Dextran Injection
June 23, 2014
•
American Regent cannot provide a reason for the shortage.
Article link:
Pentostatin Injection
June 24, 2014
•
Ben Venue has stopped production in its plant in Bedford, Ohio and will close in
2014. Ben Venue has stopped production in its plant in Bedford, Ohio and will close in
early 2014. Ben Venue supplies multiple sterile injectable products for Bedford
Laboratories. Supplies of product that has already been manufactured will continue to
be released until inventory is depleted. Bedford Laboratories has a small number of
products manufactured elsewhere that are not affected by this closure.
94
Article link:
Labetalol Injection
June 24, 2014
•
•
•
•
•
Supplies of product that have already been manufactured will continue to be released
Hospira had labetalol on shortage due to manufacturing delays and increased demand.
Apotex discontinued their 4 mL vials (NDC 60505-0717-00) in February, 2010. The
company could not provide a reason for the discontinuation.
Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013.
Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013 and 40 mL
vials in February 2014.
Article link:
Cefotaxime Injection
June 24, 2014
•
•
•
Fresenius Kabi discontinued all cefotaxime presentations in April 2011.
Hospira has Claforan on shortage due to manufacturing delays.
Baxter could not provide a reason for the shortage.
Article link:
95
Nalbuphine Injection
June 26, 2014
•
•
•
Endo discontinued Nubain in 2008.
Teva discontinued all nalbuphine injections in July, 2010.
Hospira has nalbuphine on shortage due to manufacturing delays.
Article link:
Methylergonovine Maleate
June 26, 2014
•
•
Akorn could not provide a reason for the shortage of methylergonovine maleate
injection.
American Regent has methylergonovine maleate injection on back order due to
manufacturing delays
Article link:
Echothiophate Powder for Ophthalmic Solution
June 26, 2014
•
Pfizer is the only manufacturer of echothiophate powder for ophthalmic solution
(Phospholine Iodide).
Article link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=85
96
Hydrocortisone Sodium Succinate Injection
June 30, 2014
•
•
Hospira has A-Hydrocort on shortage due to requirements related to good
manufacturing practices.
Pfizer had Solu-Cortef on shortage due to manufacturing delays.
Article link:
Bumetanide Tablets
June 30, 2014
•
•
•
Mylan Institutional discontinued bumetanide tablets in March 2014.
Teva cannot provide a reason for the shortage
Article link:
Vasopressin Injection
July 02, 2014
•
•
•
•
American Regent had temporarily suspended manufacture of most drug products
including vasopressin injection in April, 2011.1
American Regent resumed manufacturing in Shirley, New York in early-May, 2011.2
American Regent recalled 17 lots of vasopressin in August, 2011 due to potential for
decreased potency.
JHP had Pitressin on shortage due to increased demand for the product.3
97
•
Fresenius Kabi (formerly APP) had vasopressin on shortage due to increased demand for
the product.4
Article link:
Testosterone Cypionate Intramuscular Injection
July 02, 2014
•
•
•
Paddock has testosterone on back order due to increased demand and shipping delays
from their contract manufacturer.
West-Ward had testosterone cypionate on shortage due to manufacturing delays.
Sandoz discontinued testosterone cypionate 200 mg/mL 1 mL and 10 mL vials in
September 2011. Sandoz discontinued final presentation in first half of 2012.
Article link:
Ciprofloxacin Immediate-Release Tablets
July 03, 2014
•
•
•
•
•
•
•
Ranbaxy has an FDA import ban on several of their products manufactured in India.
Carlsbad Technology discontinued ciprofloxacin tablets in 2014.
Marlex is unable to provide a reason for their shortage.
Major discontinued their ciprofloxacin immediate-release tablets in February, 2010.
Teva discontinued their ciprofloxacin immediate-release tablet, unit dose presentations
in June, 2010.
Schering has discontinued all Cipro immediate-release tablet presentations.
UDL has discontinued all ciprofloxacin immediate-release 250 mg unit-dose tablets.
Article link:
98
Cidofovir Injection
July 03, 2014
•
•
Gilead recalled one lot of Vistide on February 4, 2013, due to particulate matter in some
vials.
Mylan Institutional launched cidofovir injection in mid-March 2013.
Article link:
Terbutaline Sulfate Injection
July 07, 2014
•
•
Akorn has discontinued terbutaline injection.
Article link:
Empty Evacuated Containers
July 08, 2014
•
•
Baxter has empty evacuated containers on shortage due to supply constraints.
B. Braun has evacuated glass containers on shortage due to increased demand for the
product and raw material constraints
99
Article link:
Chromium (Chromic Chloride) Injection
July 08, 2014
•
•
•
Hospira has chromium (chromic chloride) injection on shortage due to manufacturing
delays.
American Regent had temporarily suspended distribution of most drug products
including chromium (chromic chloride) injection in April, 2011.
Article link:
Caffeine and Sodium Benzoate Injection
July 08, 2014
•
•
•
•
American Regent had temporarily suspended manufacture of multiple drug products
including caffeine and sodium benzoate injection in April, 2011.
American Regent is the sole manufacturer of caffeine and sodium benzoate injection.
Caffeine citrate injection is not affected by this shortage.
Article link:
100
Ethambutol Tablets
July 09, 2014
•
•
•
VersaPharm states the reason for the shortage is change in manufacturing facility.
X-Gen could not provide a reason for the shortage.
G&W Laboratories discontinued ethambutol tablets in mid-April 2013.
Article link:
Dihydroergotamine Mesylate Injection
July 09, 2014
•
•
•
Valeant cannot provide a reason for the shortage of dihydroergotamine mesylate
injection.
Paddock states the reason for the shortage is manufacturing delay.
Article link:
Clarithromycin Immediate-Release Tablets
July 09, 2014
•
Ranbaxy has an import ban on their products.
101
•
•
•
•
•
Apotex import ban has been lifted, but the company is not marketing clarithromycin
immediate-release tablets in the US.
Mylan discontinued clarithromycin tablets in 2013.
UDL discontinued clarithromycin 500 mg 100 count unit-dose in May 2013.
Wockhardt has clarithromycin tablets on shortage due to regulatory delays.
Article link:
Cephalexin Oral Suspension
July 09, 2014
•
•
•
•
Orchid/Karalax discontinued all cephalexin oral suspension products in the 3rd Quarter
of 2013.
Ranbaxy has an import ban on their cephalexin oral suspension products.
Carlsbad Technology, Inc. discontinued all cephalexin oral suspension products in late2012 due manufacturing cost and shortage or raw materials.
Article link:
Rifampin for Injection
July 11, 2014
•
102
•
•
•
Akorn discontinued rifampin in September 2013 due to shortage of raw material.
Mylan Institutional acquired rifampin injection from Pfizer on December 7, 2013.
Mylan Institutional discontinued rifampin injection in June 2014.
Article link:
Propranolol Injection
July 11, 2014
•
•
•
•
Bedford Laboratories has a small number of products manufactured elsewhere that are
not affected by this closure.
Fresenius Kabi had propranolol injection available but with short-expiration dating.
West-Ward has propranolol injection on shortage due to manufacturing delays.
Article link:
Sodium Thiosulfate Injection
July 14, 2014
•
•
•
American Regent has recently upgraded their manufacturing plant. Product will become
available in stages as production resumes.
Hope Pharmaceutical received FDA approval of their sodium thiosulfate product in
February, 2012. Hope Pharmaceutical has the only FDA approved product of sodium
thiosulfate.
Hope also has Nithiodote available, a combination of sodium thiosulfate and sodium
nitrite.
103
Article link:
Lactated Ringer’s Injection Bags
July 14, 2014
•
•
•
Baxter has lactated ringer’s on shortage due to increased demand.
BBraun has lactated ringer’s on allocation due to increased demand.
Hospira cites increased demand as the reason for the shortage.
Article link:
Fluconazole Injection
July 14, 2014
•
•
•
•
Teva has fluconazole injection on shortage due to manufacturing delays.
Pfizer had fluconazole injection on shortage due to manufacturing delays related to
labeling changes.
West-Ward has fluconazole injection on shortage due to manufacturing delays.
Article link:
Ezetimibe and Atorvastatin Tablets
July 14, 2014
104
•
In January 2014, Merck recalled all Liptruzet lots from wholesalers due to packaging
defects in the outer laminate foil pouches.
Article link:
Citric acid and Potassium Citrate Oral
July 14, 2014
•
Cypress Pharmaceuticals has Cytra-K crystals on back order due to a raw material supply
issue.
Article link:
Amphotericin B Cholesteryl Sulfate Complex Injection
July 14, 2014
•
•
•
Kadmon had acquired Three Rivers Pharmaceuticals in October 2010 and Amphotec was
part of the product portfolio.
Kadmon recently sold Amphotec to Alkopharma. Alkopharma is the sole supplier of
amphotericin b cholesteryl sulfate lipid complex. The contracted manufacturer of
Amphotec was Ben Venue Laboratories.
105
•
The shortage of amphotericin b cholesteryl sulfate lipid complex is not affecting other
amphotericin formulations.
Article link:
Aminophylline Injection
July 14, 2014
•
•
•
•
•
American Regent had temporarily suspended distribution of most drug products in April,
2011.
Hospira states that the shortage is due to manufacturing delays.
Hospira discontinued aminophylline ampules in September, 2011.
Theophylline injection is available from BBraun and may be affected by this shortage.
Article link:
Cisatracurium Injection
July 15, 2014
•
•
Sandoz could not provide a reason for the shortage.
Nimbex injection is on shortage due to increased demand.
Article link:
Tetracycline Capsules
July 17, 2014
106
•
•
•
•
Due to the shortage, combination products that contain oral tetracycline may be
affected as well.
Heritage launched tetracycline capsules in October 2013.
Teva states tetracycline capsules are unavailable due to a raw material shortage.
Watson discontinued tetracycline capsules in October 2013. The company could not
provide a reason for the discontinuation.
Article link:
Prednisone Tablets
July 17, 2014
•
•
•
•
•
Cadista states the shortage is due to a raw materials shortage.
Perrigo discontinued prednisone tablets in 2013.
Roxane and Watson could not provide a reason for the shortage.
Qualitest discontinued prednisone 20 mg tablets in August 2013.
West-Ward states the reason for the shortage is manufacturing delays.
Article link:
Methotrexate Tablets
July 17, 2014
•
•
Major discontinued methotrexate tablets in 2013.
Mylan could not provide a reason for the shortage.
Article link:
107
Doxorubicin Liposomal Injection
July 17, 2014
•
•
•
•
Janssen Products, LP states the shortage is due to manufacturing issues. Janssen
Products, LP has updates with information about the shortage on the Doxil website that
is updated regularly.1-3
Janssen is working to transition Doxil manufacturing to additional suppliers. A
temporary solution to this shortage was to use areas of the Ben Venue Laboratories
facility available for production and other partners to complete the manufacturing
process. FDA exercised regulatory discretion and approved an additional lot of 2 mg/mL
10 mL (20 mg) vials.
Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can
supply the market with their presentations.
Article link:
Mirtazapine Tablets
July 18, 2014
•
•
•
•
•
Actavis (Watson) cannot provide a reason for the shortage.
Actavis discontinued their mirtazapine 15 mg oral disintegrating tablets in May 2014.
Greenstone discontinued all remaining mirtazapine presentations in December 2013.
Sandoz discontinued their mirtazapine presentations in early-2014.
Teva discontinued various unit dose presentations throughout 2013, including
mirtazapine. Teva could not provide a reason for the shortage
108
Article link:
Vincristine Injection
July 21, 2014
•
•
Hospira states the shortage was due to manufacturing delays.1
Teva states vincristine injection is on shortage due to manufacturing delays.2
Sulfacetamide and Prednisolone Ophthalmic Ointment
July 21, 2014
•
•
Allergan states the reason for shortage was difficulty in obtaining the raw materials
needed for manufacturing.
Allergan is the sole supplier of sulfacetamide 10% and prednisolone 0.2% ophthalmic
ointment and ophthalmic suspension.
Article link:
Dibucaine Ointment
July 21, 2014
•
•
•
Perrigo and Fougera cannot provide a reason for the shortage.
Geritrex introduced dibucaine 1% ointment in March 2014.
Novartis divested the rights for all Nupercainal ointment products to Ducere Pharma in
2013.
109
•
These products are available Over-The-Counter.
Article link:
Atropine Sulfate Injection
July 21, 2014
•
•
•
American Regent had temporarily suspended manufacture of most drug products in
April, 2011.
Hospira states the shortage is due to manufacturing delays.
Article link:
Atracurium Injection
July 21, 2014
•
•
•
Hospira launched atracurium in mid-2013.
Sagent as atracurium on allocation due to manufacturing delays.
Article link:
110
Nicardipine Hydrochloride Injection
July 22, 2014
•
•
•
•
•
•
•
Cornerstone Therapeutics discontinued Cardene ampules in March 2014. The company
could not provide a reason for the discontinuation.
Teva recalled 4 lots nicardipine injection because the product did not meet purity
specifications. The recalled lots are 31302508B, 31302510B, 31302957B, 31303195B.
Teva discontinued nicardipine injection in September, 2010.
American Regent had temporarily suspended distribution of all drug products in April,
2011.
American Regent resumed manufacturing in Shirely, New York in early-May, 2011.
Mylan Institutional could not provide a reason for the shortage.
Wockhardt has nicardipine on shortage due to an FDA import alert.
Ethiodized Oil
July 23, 2014
•
•
•
Savage / Nycomed no longer manufactures Ethiodol solution for injection due to a
marketing decision.1
In cooperation with FDA, Guerbet was importing Lipiodol Ultra-Fluide.2,3
Guerbet received FDA approval of Lipiodol in April 2014.
Article link:
Desmopressin Injection
July 23, 2014
111
•
•
Teva and Hospira have desmopressin injection on shortage due to manufacturing
delays.
Sanofi could not provide a reason for the shortage.
Article link:
Barium Sulfate Oral Suspension
July 23, 2014
•
•
Bracco Diagnostics states the reason for the shortage is manufacturing delay, as well as
increased demand. Bracco Diagnostics has provided a customer letter detailing the
reason for the shortage and barium sulfate presentations affected.1
Bracco discontinued multiple products in August 2013 in order to streamline their
product portfolio. Table 1 summarizes the barium products that were discontinued.
Bracco has provided an updated product portfolio detailing the product changes and the
recommended alternate products.1
Article link:
Rabies Immune Globulin
July 25, 2014
•
Sanofi Pasteur states the reason for the shortage is increased demand and
manufacturing delay.1
Article link:
112
Procainamide Hydrochloride Injection
July 25, 2014
•
•
Hospira had procainamide injection on shortage due to manufacturing delays.
There are no other manufacturers of procainamide injection.
Article link:
Multiple Vitamins for Infusion
July 25, 2014
•
•
Baxter states the reason for the shortage is manufacturing delays.
Article link:
Lidocaine with Epinephrine Injection
July 25, 2014
•
•
Hospira has lidocaine with epinephrine presentations on shortage due to manufacturing
delays.
Fresenius Kabi (formerly APP) has Xylocaine with epinephrine presentations on shortage
due to increased demand for the product.
Article link:
113
Copper Injection
July 25, 2014
•
•
•
American Regent had temporarily suspended manufacture of most drug products in
April, 2011.
Hospira had cupric chloride on shortage due to manufacturing delays.
Article link:
Chorionic Gonadotropin (Human) Injection
July 25, 2014
•
Merck (formerly Schering-Plough) states their product is on allocation to prevent use in
the gray market.
Article link:
Chloroprocaine Injection
July 25, 2014
•
•
•
West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including chloroprocaine injection.
Hospira discontinued chloroprocaine injection in January, 2012 due to inability to obtain
raw materials. All supply was depleted in January.
Fresenius Kabi (formerly APP) has transitioned from 1 count presentations to 25 count
sizes. All 1 count presentations were depleted in early 2012.
114
•
Fresenius Kabi (formerly APP) had Nesacaine on shortage from depletion of raw
materials due increased demand for the product.
Article link:
Ammonium Chloride Injection
July 25, 2014
•
•
Hospira states the shortage of ammonium chloride is due to manufacturing delays.
Hospira is the sole manufacturer of ammonium chloride injection.
Article link:
Torsemide Injection
July 29, 2014
•
•
Roche discontinued Demadex injection for business reasons. Demadex tablets are not
affected by this shortage.
American Regent has torsemide on shortage due to manufacturing delays.
Article link:
Succinylcholine chloride Injection
July 29, 2014
•
Hospira had Quelicin on shortage due to manufacturing delays.1
115
•
Sandoz had Anectine on shortage due to extra quality reviews.2
Article link:
Selenium Injection
July 29, 2014
•
American Regent has selenium injection on shortage due to manufacturing delays.
Article link:
Ranitidine Injection
July 29, 2014
•
•
•
West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
ranitidine injection from Bedford in July 2014.1
Covis has Zantac on shortage due to capacity issues at the manufacturer.2
Oral ranitidine products are not affected by this shortage.
Article link:
Phenylephrine Hydrochloride Injection
July 29, 2014
•
American Regent has phenylephrine injection on shortage due to increased demand for
the product.
116
•
Sandoz could not provide a reason for the phenylephrine injection shortage.
Article link:
Papaverine Injection
July 29, 2014
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Bedford and Sandoz have discontinued their papaverine presentations.1,2
American Regent has papaverine on shortage due to manufacturing delays.3
American Regent is the sole supplier of papaverine.3
Article link:
Methylene Blue Injection
July 29, 2014
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Akorn had methylene blue on back order due to increased demand for the product. 1
American Regent has methylene blue on back order due to manufacturing delays.2
Indigo Carmine Injection
July 29, 2014
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American Regent has indigo carmine on back order due to manufacturing delays.1
Akorn has discontinued production of indigo carmine due to shortage of raw material.
Akorn is looking for a new raw material supplier.2
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Article link:
Electrolyte Concentrate
July 29, 2014
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American Regent has Nutrilyte and Nutrilyte on back order due to manufacturing delays.
Article link:
Cyanocobalamin Injection
July 29, 2014
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American Regent has cyanocobalamin injection on shortage due to manufacturing
delays.1
Fresenius Kabi has cyanocobalamin injection on shortage due to increased demand for
the product.2
Article link:
Thiotepa for Injection
July 30, 2014
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products from Bedford Laboratories in July 2014 including thiotepa injection.
FDA is allowing temporary importation of Tepadina (thiotepa), from Adienne Srl in Italy.
Product may be ordered directly through Adienne Srl. The solution is similar in
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formulation to US thiotepa. The main differences between the two products are listed
below:
o Tepadina comes in 15 mg and 100 mg vials while the US thiotepa from Bedford
only comes in a 15 mg vial. Reconstitution of the products should still yield a final
concentration of 10 mg/mL and therefore use caution in choosing vial size and
volume of diluent.
o Tepadina is indicated for different uses and therefore different dosing regimens
are on the Europe labeling compared to US labeling, but it is the same product as
in the US.
o The bar coding for the Italian product will not provide correct information to bar
code readers since the manufacturing code is not an NDC number. More
information on the product packaging and ordering procedures can be found
online.
Adienne Srl is supplying Tepadina directly to hospitals and not through wholesalers.
Orders can be placed directly with Adienne. Orders are shipped Monday through
Wednesday to ensure product can arrive prior to the weekend to prevent temperature
deviations.
There are no other manufacturers of thiotepa for injection.
Article link:
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine
July 30, 2014
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Sanofi-Pasteur has Adacel is in short supply due to manufacturing delays. This product is
also known as adult tetanus toxoid, reduced diphtheria toxoid and acellular pertussis
(Tdap) vaccine.1
Sanofi-Pasteur is in the process of implementing new NDC numbers for vaccine
products.1
GlaxoSmithKline has available Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular
Pertussis Vaccine (Boostrix). The 1 count Boostrix syringe is no longer made.2
GlaxoSmithKline has Boostrix on shortage due to increased demand.2
Adult Tetanus and Diphtheria Toxoids Adsorbed (Td) (Tenivac, Sanofi-Pasteur) is not
affected by this shortage.1
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Article link:
Morphine Injections
July 30, 2014
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Fresenius Kabi (formerly APP) states the shortage is due to a change in manufacturing
sites.
Hospira discontinued preservative-containing Carpuject syringes in August, 2012 and
replaced them with preservative-free Carpuject syringes.
West-Ward states the shortage was due to increased demand for product. West-Ward
changed old Baxter to new West-Ward NDC codes in early 2012.
IMS (Amphastar) discontinued morphine 1 mg/mL 10 mL Luer-lock syringes in March,
2012 due to low demand for the product.
Article link:
Fenoldopam Mesylate Injection
July 30, 2014
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Hospira has Corlopam on shortage due to manufacturing delays.
Article link:
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Buprenorphine Sublingual Tablets
July 30, 2014
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Article link:
Amifostine Injection
July 30, 2014
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amifostine injection from Bedford in July 2014. West-Ward is actively marketing
amifostine injection.
Caraco could not provide a reason for the shortage.
Medimmune discontinued brand name Ethyol 500 mg injection in August, 2009.
Article link:
Reteplase Injection
July 31, 2014
•
Cornerstone Therapeutics acquired EKR Therapeutics in June 2012. EKR Therapeutics
had previously purchased Retavase from PDL BioPharma. Cornerstone is seeking FDA
approval of a new supplier of the active pharmaceutical ingredient for Retevase.
Article link:
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Promethazine Injection
July 31, 2014
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Teva states the shortage is due to manufacturing delays.
West-Ward states the shortage was due to manufacturing delays. The company has also
changed the NDC numbers for products that were formerly Baxter products.
Article link:
Polymyxin B Sulfate Injection
July 31, 2014
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Fresenius Kabi (formerly APP) could not provide a reason for the shortage.
Sagent suspended manufacturing of Polymyxin B sulfate injection in October, 2012.
products from Bedford Laboratories in July 2014 including polymyxin B sulfate injection.
Article link:
Benztropine Injection
July 31, 2014
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American Regent has benztropine injection on back order due to manufacturing delays.
Fresenius Kabi USA recalled benztropine injection due to potential for glass particles in
the vials. Product may have been under APP or Nexus labels. Detailed information on
the recall can be found online.
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Article link:
Alcohol Dehydrated Injection (Ethanol)
July 31, 2014
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American Regent has alcohol dehydrated on back order due to manufacturing delays.
Hospira and Consolidated Midland discontinued all injectable alcohol dehydrated
products.
Article link:
Vecuronium Bromide Injection
August 01, 2014
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Hospira states the shortage is due to manufacturing delays.1,2
Teva states the shortage is due to manufacturing delays.3
Pfizer sold vecuronium injection to Mylan Institutional in December 2013.4,5
Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.6
Sagent temporarily suspended the manufacture of vecuronium 10 mg and 20 mg vials.8
Article link:
Tolterodine Tartrate Extended Release Capsules
August 01, 2014
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Mylan discontinued tolterodine extended release 2 mg and 4 mg capsules in 90 count
bottles in April 2014.
Article link:
Sulfamethoxazole and Trimethoprim Oral Suspension
August 01, 2014
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Aurobindo could not provide a reason for the shortage.
Hi-Tech Pharmacal discontinued all presentations of sulfamethoxazole and
trimethoprim oral suspension in June 2014.
Pharmaceutical Associated discontinued sulfamethoxazole and trimethoprim oral
suspension in September 2013.
Article link:
Sodium Chloride 0.9% Injection Bags
August 01, 2014
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Baxter has 0.9% sodium chloride on shortage due to increased demand.1
BBraun had 0.9% sodium chloride on allocation due to increased demand.2
Hospira cites increased demand as the reason for the shortage.3
In cooperation with the FDA, Fresenius Kabi is providing 0.9% sodium chloride to the US
market to help alleviate the national shortage. This 0.9% sodium chloride is
manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. There will be
presentations available with Australian/English label and the package insert is the same
for all imported presentations.4,5
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In cooperation with the FDA, Baxter is providing imported 0.9% sodium chloride to the
US market to help alleviate the national shortage. This 0.9% sodium chloride in Viaflo
containers is manufactured in Spain by Baxter.
Article link:
Secretin Injection
August 01, 2014
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ChiRhoClin is qualifying a manufacturing site.
ChiRhoClin is working with FDA to allow the release of ChiRhoStim lot # 0636149. This
lot was produced at a new manufacturing site that has not been approved by FDA.
Please see the Dear Health Care Provider letter.
Article link:
Phosphorus Oral Supplements
August 01, 2014
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Cypress Pharmaceuticals has Phos-Nak Powder on back order due to manufacturing
delays.1
Article link:
Metronidazole Injection
August 01, 2014
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Hospira has metronidazole injection on back order due to manufacturing delays.
Baxter, BBraun, and Claris are allocating metronidazole injection due to increased
demand for the product.
Article link:
Magnesium Sulfate Injection
August 01, 2014
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American Regent has magnesium sulfate on shortage due to manufacturing delays.
Fresenius Kabi (formerly APP) had magnesium sulfate injection on shortage due to
increased demand for the product.
Hospira has magnesium sulfate injection on shortage due to manufacturing delays.
Article link:
Heparin Sodium Injection
August 01, 2014
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FDA has issued import bans against 22 Chinese manufacturers of heparin due to
inadequate good manufacturing practices (GMPs).1
West-Ward obtained five presentations of the heparin sodium injection from Baxter in
September, 2011. Baxter only retained two large volume heparin presentations. All
other Baxter presentations have been discontinued.2,3
Fresenius Kabi (formerly APP) reports that heparin products are on back order due to
increased demand for the product.4
Hospira states the shortage of heparin vials is due to manufacturing delays.5
Covidien and B. Braun could not provide a reason for the shortage.9,11
Sagent has heparin on shortage due to increased demand for the product.6
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Article link:
Doxorubicin Injection
August 01, 2014
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Ben Venue stopped production in is plant in Bedford, Ohio, and closed in July 2014. Ben
Venue supplied multiple sterile injectable products for Bedford Laboratories.1
Pfizer had doxorubicin solution for injection on shortage due to shipping delays.5
Sagent introduced doxorubicin injection in November 2013.6
Mylan Institutional acquired doxorubicin lyophilized powder from Pfizer on December 6,
2013.7
Article link:
Dobutamine Injection
August 01, 2014
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Baxter had dobutamine on back order due to increased demand and manufacturing
constraints.
Hospira has dobutamine on shortage due increased demand for the product.
products from Bedford Laboratories in July 2014 including dobutamine injection.
Article link:
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Dexamethasone Sodium Phosphate
August 01, 2014
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American Regent has dexamethasone sodium phosphate on shortage due to
manufacturing delays.1
Fresenius Kabi (formerly APP) states the dexamethasone sodium phosphate shortage
was due to supply and demand issues.2
Baxter could not provide a reason for the shortage. Baxter sold several products to
West-Ward in mid-2011.3
West-Ward had dexamethasone sodium phosphate injection on shortage due to
increased demand.4
Pfizer divested all dexamethasone presentation to Mylan Institutional on December 6,
2013.4,5
Article link:
Calcium Gluconate Injection
August 01, 2014
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American Regent has calcium gluconate on shortage due to manufacturing delays.
Fresenius Kabi had calcium gluconate on shortage due to increase demand for the
product.
American Regent has issued a statement that all lots of calcium gluconate may contain
glass particles and filters must be used. Do not use if there are visible glass particles and
filter all other product.
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Amikacin Injection
August 01, 2014
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amikacin injection from Bedford in July 2014.1
Hospira discontinued amikacin in May, 2010 due to a raw material shortage.2
Teva’s product was unavailable due to manufacturing delays.3
Sandoz discontinued Amikin injection in 2006.4
Heritage launched amikacin injection in March 2014.5
Article link:
Tamoxifen Tablets
August 04, 2014
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Teva and Mylan could not provide a reason for the shortage.
Actavis could not provide a reason for the shortage.
Article link:
Mitomycin Injection
August 04, 2014
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Ben Venue has stopped production in its plant in Bedford, Ohio and close in July 2014. 1,2
Accord states the reason for the shortage was increased demand.3
Article link:
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Lidocaine Injection
August 04, 2014
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Hospira has lidocaine presentations on shortage due to manufacturing delays.
Fresenius Kabi, USA (formerly APP) has Xylocaine and lidocaine presentations on
shortage due to increased demand for the product.
Amphastar had lidocaine 2% emergency syringes on shortage due to increased demand
for the product.
BBraun has lidocaine and dextrose premixed bags on shortage due to increased demand
for the product.
Baxter discontinued two lidocaine and dextrose premixed bag presentations in March,
2012.
AuroMedics introduced lidocaine injection in February 2014.
Article link:
Ketamine Injection
August 04, 2014
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products from Bedford Laboratories in July 2014 including ketamine injection.
Article link:
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Haemophilus B Conjugate Vaccine
August 04, 2014
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Sanofi Pasteur had ActHIB in short supply due to the shortage of other combination
vaccines (eg, Pentacel®).1
GlaxoSmithKline cannot provide a reason for the shortage of Hiberix but it has not been
manufactured since 2011.2
Merck announced in March 2014 plans to discontinue Comvax vaccine. Product will no
longer be available directly from Merck after December 31, 2014.3
Article link:
Azithromycin Injection
August 04, 2014
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Fresenius Kabi could not provide a reason for the shortage.
Hospira has azithromycin injection on shortage due to increased demand.
Sagent has azithromycin injection on shortage due to increased demand.
Pfizer discontinued Zithromax 500 mg vial with Vial-Mate Adaptor in January 2013.
Article link:
Azathioprine Injection
August 04, 2014
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azathioprine injection from Bedford in July 2014.
There are no other manufacturers of azathioprine injection.
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The oral presentations are not affected by this shortage.
Article link:
Aspirin Tablets (Buffered)
August 04, 2014
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Novartis has temporarily suspended manufacture of multiple drug products that were
manufactured at the Lincoln facility including Bufferin and Ascriptin Tablets.
Novartis voluntarily recalled all lots of Bufferin Tablets with expiration dates of
December 20, 2013 or earlier.
Novartis divested the rights for all Bufferin products to Ducere Pharma in early-2013.
Ducere Pharma re-introduced Bufferin tablets in late 2013.
Medique Products discontinued their buffered aspirin presentations in May, 2012.
Major states the shortage was due to increased demand for the product.
Teva discontinued their buffered aspirin products late 2009 and early 2010.
Article link:
Adenosine Injection
August 04, 2014
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Akorn launched adenosine 3 mg/mL 2 mL vials 25 count in April 2013.
Astellas had Adenoscan on back order due to increased demand. This back order is now
resolved. Adenoscan is used for diagnostic purposes as an adjunct to thallium-201
myocardial perfusion scintigraphy. Adenocard and generic adenosine products are
labeled for use in paroxysmal supraventricular tachycardia.
Ben Venue has stopped production in its plant in Bedford, Ohio and closed in July 2014.
Sagent has adenosine vials on shortage due to manufacturing delay.
Teva has discontinued their adenosine injection.
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Wockhardt discontinued their adenosine 3 mg/mL 2 mL and 4 mL syringes.
Article link:
Morrhuate Sodium Injection
August 05, 2014
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American Regent has morrhuate sodium injection on shortage due to manufacturing
delays.
Article link:
Glycopyrrolate Injection
August 05, 2014
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American Regent had glycopyrrolate on shortage due to manufacturing delays.
West-Ward is focusing production on generic glycopyrrolate.
Article link:
Ticarcillin Clavulanate
August 06, 2014
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GlaxoSmithKline could not provide a reason for the shortage.
GlaxoSmithKline discontinued Timentin 3.1 gram ADD-Vantage vials in late-2012.
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Article link:
Sodium Chloride Concentrated Solution for Injection
August 06, 2014
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American Regent discontinued 23.4% sodium chloride 30 mL and 100 mL presentations
in 2012.
Baxter discontinued their sodium chloride 250 mL presentation in 2008.
Fresenius Kabi (formerly APP) has sodium chloride concentrated solution on shortage
due to increased demand. Fresenius Kabi discontinued 14.6% sodium chloride 20 mL
Hospira has 14.6% and 23.4% sodium chloride solutions for injection on shortage due to
manufacturing delays. Hospira discontinued sodium chloride 14.6% solution 250 mL
Article link:
Sincalide Injection
August 06, 2014
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Bracco Diagnostics has Kinevac on shortage due to manufacturing delays.
There are no approved alternatives to Kinevac for the labeled indications
Article link:
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Potassium Chloride Injection
August 06, 2014
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Hospira states the reason for the shortage is manufacturing delays.
Fresenius Kabi and Baxter could not provide a reason for the shortage.
Article link:
Oxytocin Injection
August 06, 2014
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Fresenius Kabi, USA (formerly APP) states the shortage is due to increased demand.
Par Sterile Products (formerly JHP) discontinued generic oxytocin injection in July 2014.
West-Ward states the shortage is due to stock becoming short-dated.
Article link:
Metoprolol Injection
August 06, 2014
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American Regent has metoprolol injection on shortage due to manufacturing delays.1,2
Fresenius Kabi, Hospira and Sagent state the shortage was due to increased demand for
the product.3,4,7
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.5,6
Article link:
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Isosorbide Dinitrate Immediate Release Tablets
August 06, 2014
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Major discontinued isosorbide dinitrate 5 mg immediate release tablets in April 2012.
Major discontinued isosorbide dinitrate 10 mg immediate release tablets in April 2013.
Major discontinued isosorbide dinitrate 20 mg immediate release tablets in June 2013.
West-Ward discontinued several isosorbide dinitrate immediate release tablet
presentations in December 2013.
West-Ward states the shortage was due to manufacturing delays.
Article link:
Indocyanine Green
August 06, 2014
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Akorn states the reason for the shortage is increased demand.
Hub Pharmaceuticals cannot provide a reason for the shortage.
Article link:
Hydromorphone Hydrochloride Injection
August 06, 2014
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Hospira has hydromorphone injection on shortage due to manufacturing delays
Article link:
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Gentamicin injection
August 06, 2014
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Hospira has gentamicin on shortage due to manufacturing delays1
Fresenius Kabi (formerly APP) had gentamicin on shortage due to increased demand.
Fresenius Kabi discontinued their 10 mg/mL 2 mL multi-dose vial in mid-20112
Baxter has gentamicin on shortage due to increased demand.3
Article link:
Fentanyl Injection
August 06, 2014
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West-Ward acquired Baxter’s fentanyl injection products in May, 2011. The company
began changing NDC numbers in July, 2012.1,2
West-Ward states the shortage was due to a manufacturing delay for the fentanyl 50
mcg/mL 20 mL ampules. The 20 mL vials were in short supply due to increased
demand.1
Hospira states the shortage is due to increased demand and manufacturing delays
including quality improvement activities. Hospira is increasing production of the
ampules to help meet the demand. 3
Akorn launched Sublimaze injection in late-March, 2012.4
Article link:
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Epinephrine Injection
August 06, 2014
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American Regent has epinephrine on shortage due to manufacturing delays.
Hospira has epinephrine syringes on shortage due to manufacturing delays.
JHP states the reason for the shortage was due to increased demand.
JHP discontinued three epinephrine presentations in late-2013.
Amphastar states the shortage is due to increased demand. Amphastar changed the
NDC numbers of their epinephrine products in November 2012.
Article link:
Enalaprilat Injection
August 06, 2014
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Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.
Teva has discontinued both of their products.
Hospira has enalaprilat injection on shortage due to manufacturing delays.
West-Ward has enalaprilat injection on shortage due to manufacturing delays.
Article link:
Droperidol Injection
August 06, 2014
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American Regent has droperidol injection on back order due to manufacturing delays.
Hospira has droperidol on back order due to shortage of raw material.
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Article link:
Dipyridamole Injection
August 06, 2014
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Bedford discontinued dipyridamole injection in May, 2011 to concentrate on the
manufacturing of other products.
Teva has temporarily discontinued their 2 mL and 10 mL products in order to increase
the package sizes.
Article link:
Dexpanthenol Injection
August 06, 2014
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American Regent has dexpanthenol injection on shortage due to manufacturing delays.
There are no other suppliers of dexpanthenol injection.
Article link:
Calcitriol Injection
August 06, 2014
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Akorn has calcitriol injection on shortage due to increased demand for the product.
American Regent has calcitriol on back order due to manufacturing delays.
Abbott discontinued Calcijex in April 2012.
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West-Ward discontinued their calcitriol injection in May, 2011.
Calcitriol capsule and oral solution presentations are available from multiple
manufacturers.
Fresenius Kabi (formerly APP) discontinued calcitriol injection in January 2014.
Article link:
Bupivacaine with epinephrine Injection
August 06, 2014
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Fresenius Kabi (formerly APP) has Sensorcaine with epinephrine on shortage due to
Hospira has bupivacaine with epinephrine and Marcaine with epinephrine on shortage
due to manufacturing delays.
Article link:
Zinc Injection
August 07, 2014
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Hospira states the shortage of zinc chloride injection is due to manufacturing delays.
Hospira is the only manufacturer of zinc chloride injection.
American Regent states the shortage of zinc sulfate injection is due to manufacturing
delays.
FDA is allowing temporary importation of zinc gluconate trihydrate 1 mg/mL 10 mL vials
from Aguettant Laboratories in France. This product is being distributed through Baxter
Healthcare. The labeling will come in the original container which is in French.
Information translated into English along with a table comparing the US and French
products can be found in the Dear Healthcare Professional Letter.
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Article link:
Verapamil Injection
August 07, 2014
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Hospira is the sole supplier if verapamil injection
Article link:
Sodium Phosphate Injection
August 07, 2014
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American Regent has sodium phosphate injection on back order due to manufacturing
delays.1,2
American Regent has issued a statement that all lots of sodium phosphate have
potential for crystallization. Do not use if any particles are present.3,4
Hospira has sodium phosphate injection on shortage due to manufacturing delays. 5
In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium
glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos
is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG.6
Fresenius Kabi launched sodium phosphate injection in mid-January 2014.7
Article link:
Potassium Acetate Injection
August 07, 2014
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Hospira states the shortage was due to manufacturing delays.
Hospira and American Regent discontinued potassium acetate 2 meq/mL 100 mL bulk
packages.
American Regent has potassium acetate on shortage due to manufacturing delays.
Article link:
Methyldopate Injection
August 07, 2014
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American Regent has methyldopate injection on shortage due to manufacturing delays.
There are no other suppliers of methyldopate injection
Article link:
Memantine Hydrochloride
August 07, 2014
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Forest states the reason for the shortage of Namenda XR capsules is manufacturing
delay.
Forest plans to discontinue all Namenda immediate-release tablets in Fall 2014. The
discontinuation date was extended from August 2014 to Fall 2014 to ensure adequate
supplies of the Namenda XR product. Forest states the reason for discontinuing the
Namenda immediate-release tablets is to focus on the Namenda XR extended-release
capsules.
Forest will continue to market Namenda oral solution.
Article link:
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Mannitol Inhalation Capsules
August 07, 2014
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Pharmaxis states the reason for the shortage is manufacturing delay.
There are no other manufacturers of mannitol inhalation capsules.
Article link:
Haloperidol Lactate Injection
August 07, 2014
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products from Bedford Laboratories in July 2014 including haloperidol lactate injection.
Sagent has haloperidol lactate on shortage due to manufacturing delays.
Teva has haloperidol lactate on shortage due to manufacturing delays.
Mylan Institutional acquired haloperidol lactate injection from Pfizer on December 6,
2013.
Patriot Pharmaceuticals states the reason for the shortage was increased demand.
Article link:
Haloperidol Decanoate Injection
August 07, 2014
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Teva products are on shortage due to manufacturing delays.
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Article link:
etomidate Injection
August 07, 2014
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American Regent has etomidate injection on shortage due to manufacturing delays.
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
Hospira has Amidate injection on shortage due to manufacturing delays.
Mylan Institutional acquired etomidate injection from Pfizer on December 6, 2013.
Mylan Institutional divested some presentations of etomidate injection to JHP
Pharmaceuticals in April 2014.
Mylan recalled 10 lots of etomidate injection with the Pfizer label in February 2014. The
recall was due to the presence of particulate matter and missing lot numbers and
expiration dates on the vials.
Par Pharmaceuticals acquired JHP Pharmaceuticals in early 2014.
Article link:
Cytarabine Injection
August 07, 2014
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•
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Fresenius Kabi (formerly APP) has cytarabine on shortage due to increased demand.1
products from Bedford Laboratories in July 2014 including cytarabine injection.2
Mylan Institutional acquired cytarabine injection from Pfizer on December 6, 2013.4,5
Mylan discontinued cytarabine 20 mg/mL 25 mL vials in 2014.
Article link:
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Cefpodoxime
August 07, 2014
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Ranbaxy has an import ban on all solid medications including cefpodoxime.
Aurobindo could not provide a reason for the shortage.
Pfizer has discontinued Vantin.
Sandoz could not provide a reason for the shortage.
Article link:
Calcium Chloride Injection
August 07, 2014
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•
American Regent has calcium chloride on shortage due to manufacturing delays.
Hospira has calcium chloride on shortage due to manufacturing delays.
Article link:
Black Widow Antivenin (Latrodectus Mactans)
August 07, 2014
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Merck has low inventory of Antivenin Latrodectus Mactans.
Merck, working in combination with FDA, announced on July 3, 2014 that the expiration
date for Antivenin lot H019984 was extended to January 3, 2015. The packaged
Antivenin lot H019984 contains one vial of Antivenin lot 0672105, one vial of sterile
diluent lot 0671078, and a 1 mL vial of horse serum for sensitivity testing. The expiration
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dating for the sterile diluent has not been extended. Discard the sterile diluent and
reconstitute the Antivenin vial with 2.5 mL of sterile water for injection.
Article link:
Ampicillin Sulbactam
August 07, 2014
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•
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AuroMedics Pharma launched new product in mid-June, 2012.
Hospira states that ampicillin sulbactam vials are on back order due to manufacturing
delay.
Mylan Institutional discontinued ampicillin sulbactam injection in late 2013.
Sagent has ampicillin sulbactam vials on allocation due to increased demand for the
product.
Pfizer and Sandoz cannot provide a reason for the shortage.
WG Critical Care launched ampicillin sulbactam 1.5 gram vials in March 2014.
West-Ward acquired several Baxter products in early 2011.
Article link:
Aminocaproic Acid Injection
August 07, 2014
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American Regent has aminocaproic acid on shortage due to manufacturing delays.
Article link:
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Alprostadil Products
August 07, 2014
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•
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Bedford discontinued alprostadil in May, 2011 to concentrate on the manufacturing of
other products.
Teva’s product is on long-term back order due to manufacturing difficulties.2
Pfizer’s Caverject Impulse was on backorder while the product was reformulated. The
company has discontinued Caverject injection 10 mcg lyophilized powder and 20
mcg/mL solution for injection.3
Actient has acquired several products from Schwarz (UCB) including Edex cartridges in
2010.4,5
Auxilium acquired Actient’s urology products including Edex cartridges in April 2013.6
Meda Pharmaceuticals has acquired Muse from Vivus.7,8
Article link:
Tenecteplase Injection
August 08, 2014
•
Genentech states TNKase is on shortage due to increased demand.
Article link:
Sterile Empty Vials
August 08, 2014
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147
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Fresenius Kabi (formerly APP) reduced production of sterile empty vials to permit
increased production of drug products affected by critical shortages.
Sterile empty vials may be available from medical supply distributors.
Article link:
Lorazepam injectable presentations
August 08, 2014
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•
•
•
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Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of
other products.1
West-Ward acquired Baxter’s lorazepam injection products in May, 2011. NDC numbers
for the lorazepam and Ativan products were changed in April, 2012.
West-Ward has Ativan on back order due to increase surplus of the lorazepam
presentations.2
Hospira states lorazepam vials are on shortage due to increased demand and
manufacturing delays. The 1 mL iSecure syringes were discontinued in September 2011.3
Akorn increased production to help meet demand.4
Amphastar had lorazepam 2 mg/mL vials on shortage due to increased demand.5
Article link:
Leucovorin Calcium Injection
August 08, 2014
•
leucovorin calcium injection from Bedford in July 2014. West-Ward is not actively
marketing amifostine injection at this time.1
148
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Teva has leucovorin on shortage due to manufacturing delays. Teva imported leucovorin
calcium (calcium folinate solution) 30 mL vials available; however, all product expired in
July 2014. Teva will not be importing any additional calcium folinate solution.2
Fresenius Kabi (formerly APP) has leucovorin on shortage due to increase demand.3
Fusilev (levoleucovorin) and leucovorin oral tablets are not affected by the shortage.4-7
Article link:
Ketorolac Tromethamine Injection
August 08, 2014
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American Regent discontinued all ketorolac injection presentations in 2010.
Fresenius Kabi (formerly APP) states the shortage was due to manufacturing delays.
Cura filed for bankruptcy in 2010.
Hospira has ketorolac on shortage due to manufacturing delays for quality improvement
activities and increased demand for the product.
Ben Venue has stopped production in its plant in Bedford, Ohio and closed in early
2014.
West-Ward has ketorolac injection on shortage due to manufacturing delays.
FDA imposed an import ban in mid-2013 on several Wockhardt products including
ketorolac.
Article link:
Hydroxyzine Injection
August 08, 2014
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American Regent has hydroxyzine injection on shortage due to manufacturing delays.
American Regent is the sole supplier of hydroxyzine injection
149
Article link:
Esmolol Injection
August 08, 2014
•
esmolol injection from Bedford in July 2014. West-Ward is not actively marketing
esmolol injection at this time.
Article link:
Doxycycline Capsules and Tablets
August 08, 2014
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•
•
Actavis states the reason for the shortage is supply and demand.8
Teva discontinued their doxycycline presentations in May 2013. 6
Major discontinued most doxycycline presentations in February 2013. The company
could not provide a reason for the discontinuation.3
Article link:
Dextrose 5% Injection Large Volume Bags
August 08, 2014
•
•
Baxter states the shortage is due to increased demand.1
BBraun had 5% dextrose on allocation due to increased demand.2
150
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Hospira states the shortage is due to increased demand and manufacturing delays.3
Article link:
Dexrazoxane Injection
August 08, 2014
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•
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dexrazoxane injection from Bedford in July 2014. West-Ward is not actively marketing
dexrazoxane injection at this time.
Biocodex USA acquired Totect from Apricus Pharmaceuticals in April 2013.
Apricus Pharmaceuticals acquired Topotarget USA in late 2011.
Topotarget worked with FDA to extend the expiration date of specific batch numbers of
Totect to 36 months. Information regarding this extension and the batch numbers can
be found in four Dear Healthcare Customer letters available online.
Article link:
Dexmethylphenidate Hydrochloride
August 08, 2014
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Teva and Mylan cannot provide a reason for the shortage
Article link:
151
Deferoxamine Mesylate Injection
August 08, 2014
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•
•
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Fresenius Kabi states the shortage is due to increased demand.
Hospira has deferoxamine on shortage due to manufacturing delays.
Teva discontinued all deferoxamine presentations in 2013.
Watson discontinued all deferoxamine presentations.
deferoxamine injection from Bedford in July 2014. West-Ward is not actively marketing
deferoxamine injection at this time.
Article link:
Ciprofloxacin Injection
August 08, 2014
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Claris, Hospira and Sagent could not provide a reason for the shortage
Article link:
Buprenorphine Injection
August 08, 2014
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American Regent has buprenorphine injection on shortage due to manufacturing delays.
Hospira had buprenorphine on shortage due to API constraints and increased demand.
West-Ward Pharmaceutical’s parent company, Hikma Pharmaceuticals, acquired
buprenorphine injection from Bedford in July 2014. West-Ward is not actively marketing
buprenorphine injection at this time.
152
Article link:
Bupivacaine Injection
August 08, 2014
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•
Fresenius Kabi (formerly APP) has Sensorcaine on shortage due to increased demand for
the product.
Hospira has Marcaine and bupivacaine on shortage due to manufacturing delays.
AuroMedics introduced bupivacaine injection in February 2014.
Article link:
Bacitracin Topical Ointment
August 08, 2014
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Sandoz, Perrigo, and G&W Labs cannot provide a reason for the shortage
Article link:
Phenytoin Injection
August 11, 2014
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West-Ward has phenytoin on allocation due to increased demand.1,2
Hospira has phenytoin ampules on shortage due to increased demand for the product.
Hospira discontinued phenytoin Carpuject syringes in August 2013 for business
reasons.3
153
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X-Gen Pharmaceuticals had phenytoin on shortage due to manufacturing delays.4
Article link:
Norepinephrine Injection
August 11, 2014
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Ben Venue closed its plant in Bedford, Ohio in July 2014.1,2
Teva temporarily discontinued norepinephrine in June 2010.3
Hospira has Levophed on shortage due manufacturing delays.4
Article link:
Tuberculin Purified Protein Derivate for Intradermal Injection
August 13, 2014
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Sanofi Pasteur states the shortage was due to production delays
JHP states the shortage was due to increased demand for the product
Article link:
Trace Elements Injection
August 13, 2014
•
American Regent has trace element injection on back order due to manufacturing
delays.1,2
154
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American Regent is the sole supplier of FDA-approved combined trace elements.
In cooperation with FDA, Fresenius Kabi USA is providing Addamel N (adult trace
element injection) and Peditrace (pediatric trace element injection) to the US market to
help alleviate the shortage. Addamel N and Peditrace are manufactured in an FDAapproved facility in Norway by Fresenius Kabi AG, the parent company of Fresenius Kabi,
USA.3
Article link:
Tobramycin Injection
August 13, 2014
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Teva has tobramycin solution for injection on shortage due to manufacturing delays.
Hospira has tobramycin on shortage due to manufacturing delays.
Fresenius Kabi has tobramycin solution for injection on shortage due to increased
demand.
Pfizer acquired tobramycin injection from Akorn in early-May, 2011.
Pfizer divested tobramycin injection to Mylan Institutional on December 6, 2013.
Article link:
Orphenadrine Citrate Injection
August 13, 2014
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Sagent has orphenadrine on shortage due to increased demand for the product.
Ben Venue closed its plant in Bedford, Ohio in July 2014. Orphenadrine was
manufactured by Ben Venue for Bedford.
155
Article link:
Octreotide Injection
August 13, 2014
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Fresenius Kabi (formerly APP) reports that the shortage is due to increased demand for
the product.
Sandoz discontinued octreotide injection in 2nd quarter 2013.
Sagent has octreotide on shortage due to increased demand for the product.
Teva has octreotide on shortage due to manufacturing delays.
octreotide injection from Bedford in July 2014. West-Ward is actively marketing
octreotide injection.
Wockhardt has octreotide on back order due to an import ban.
Sandostatin LAR presentations from Novartis are not affected by this shortage
Article link:
Methylprednisolone Acetate Injection
August 13, 2014
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Sandoz and Teva could not provide a reason for the shortage.
Pfizer had Depo-Medrol injection on shortage due to manufacturing delay.
Article link:
156
Methotrexate Injection
August 13, 2014
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•
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Sandoz recalled two lots of methotrexate 40 mL preservative-free vials in May 2013 due
to discover of particulate matter during routine quality control inspection.5
Mylan Institutional acquired methotrexate injection from Pfizer on December 6, 2013. 4, 7
Mylan Institutional divested three presentations of methotrexate injection to Intas
(Accord Healthcare) in April 2014.4,9
Bioniche was acquired by Mylan Institutional in September, 2011.4,6
Teva discontinued methotrexate 4 mL vials in October 2013 due to business reasons. 8
products from Bedford Laboratories in July 2014 including methotrexate injection.10
Mecasermin Injection
August 13, 2014
•
•
Ipsen Pharmaceuticals states the shortage is due to a manufacturing delay and raw
material shortage.
Ipsen is working with FDA to allow the release of Increlex lot #341203F. This lot was
produced at an alternate manufacturing site that has not been approved by FDA. Please
see the Dear Health Care Provider letter for additional information.
Article link:
157
Mannitol Injection
August 13, 2014
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•
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Hospira had mannitol injection on shortage due to manufacturing delays.
Fresenius Kabi had mannitol injection on shortage due to increased demand for the
product.
American Regent has mannitol injection on shortage due to manufacturing delays.
Article link:
Liotrix Tablets
August 13, 2014
•
Thyrolar tablets from Forest Laboratories are on back order due to manufacturing
changes.
Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP)
August 13, 2014
•
•
Sanofi Pasteur states the reason for the Daptacel shortage is manufacturing delay.1,2,3
Sanofi Pasteur discontinued Tripedia in 2011.
Article link:
158
Diphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and
Haemophilus B Conjugate Vaccine (DTaP - IPV/Hib)
August 13, 2014
•
Sanofi Pasteur states the reason for the shortage is manufacturing delay, which will
reduce supplies below current demand.1,2,3
Article link:
Digoxin Injection
August 13, 2014
•
West-Ward states the shortage is due to manufacturing delays.
Article link:
Dextran Low Molecular Weight (Dextran 40), 10% Injection
August 13, 2014
•
Hospira states the reason for the shortage is manufacturing delay.
Article link:
159
Cefuroxime Sodium Injection
August 13, 2014
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•
•
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Sagent states manufacture of cefuroxime 1.5 gram was suspended in March, 2013. No
further production is planned.
Hospira discontinued cefuroxime 1.5 gram and 7.5 gram vials in January, 2013.
Covis launched the new NDC numbers in August 2013.
BBraun discontinued their cefuroxime solution in December 2013.
Fresenius Kabi discontinued manufacturing cefuroxime in 2013.
Article link:
Oxycodone/Acetaminophen Oral Solution
August 14, 2014
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•
•
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Roxane states that the reason for the shortage is that they are validating a new source
for raw materials.
Roxane discontinued oxycodone/acetaminophen 5 mL unit-dose cups in July 2014.
Oxycodone/acetaminophen oral solution is not available from other manufacturers or in
other concentrations.
This shortage does not affect single-ingredient oxycodone solutions or
oxycodone/acetaminophen solid oral dosage forms
Article link:
160
Ondansetron Injection
August 14, 2014
Ondansetron 2 mg/mL vials
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•
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•
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AuroMedics did not provide a reason for the shortage.
Caraco temporarily discontinued ondansetron injection.
West-Ward acquired Baxter’s ondansetron vials for injection. West-Ward
discontinued ondansetron 2 mg/mL vials in packages of 5 in Spring, 2012.
BD launched ondansetron 2 mg/mL prefilled syringes in September 2013.
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July, 2014.
Hospira has ondansetron on shortage due to manufacturing delays.
Mylan Institutional acquired ondansetron injection from Pfizer on December 7, 2013.
Mylan Institutional temporarily discontinued ondansetron 2 mg/mL injectable products
in February 2014.
Teva is temporarily discontinuing ondansetron 20 mL injection.
West-Ward had ondansetron on back order due to increased demand.
Wockhardt has ondansetron injection on shortage due to an FDA import alert.
Ondansetron 32 mg/50 mL premixed bags
•
•
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•
•
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All presentations of ondansetron 32 mg/50 mL premixed bags have been discontinued.
Single-dose IV ondansetron 32 mg is no longer recommended due to an increased
potential for QT prolongation and has been removed from the Zofran product labeling.
The maximum dose for chemotherapy-induced nausea should not exceed 16 mg. FDA is
working with manufacturers to voluntarily recall all ondansetron 32 mg premixed bags
from the market by early 2013. Oral ondansetron dosing is not affected by the new
recommendations, including the 24 mg oral dose for chemotherapy-induced nausea and
vomiting.
Baxter has discontinued and recalled their ondansetron premixed bags.
Bedford discontinued their ondansetron premixed bags in December, 2012.
Hospira discontinued their ondansetron premixed bags in December, 2012. Product has
not been available on the market for several years.
Claris recalled all lots of their ondansetron premixed bags in mid-2010.
Claris discontinued their ondansetron premixed bags in June 2013.
Pfizer discontinued their ondansetron premixed bags in January, 2012.
161
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Teva discontinued their ondansetron premixed bags in late-November, 2012. Product
has not shipped since early 2010.
West-Ward has discontinued their ondansetron premixed bags.
Article link:
Nitroglycerin Injection
August 14, 2014
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•
•
•
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available in stages as production resumes.1
Hospira states the shortage is due to manufacturing delays.2
Hospira discontinued nitroglycerin in Dextrose 5%, 40 mg/100 mL, 500 mL glass bottles
(NDC 00409-1484-03) in 2010.2
Baxter had nitroglycerin premixes on shortage due to a raw material supply issue.3
In cooperation with FDA, Arbor Pharmaceuticals is importing glyceryl trinitrate
(Nitronal) injection to the US market to help alleviate the national shortage. This glyceryl
trinitrate is manufactured in an FDA-approved facility in Germany by Pohl Boskamp.
Glyceryl trinitrate is another name for nitroglycerin.4
Article link:
Milrinone Injection
August 14, 2014
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•
•
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Fresenius Kabi (formerly APP) states the reason for the shortage is increased demand
for the product.
West-Ward acquired Baxter’s milrinone injection vials in May 2011.
Baxter had milrinone premixed bags on shortage due to increased demand.
162
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Apotex, Bioniche, and Teva discontinued milrinone 1 mg/mL vials.
Sanofi-Aventis discontinued Primacor injection
Article link:
Tiopronin Tablets
August 15, 2014
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•
Mission Pharmacal had Thiola on shortage due to raw materials being discontinued.
Thiola tablets are supplied by Mission Pharmacal and distributed by Retrophin.
Article link:
Tamsulosin Hydrochloride Capsules
August 15, 2014
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•
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Boehringer Ingelheim cannot provide a reason for the shortage.
Actavis and Zydus state the reason for the shortage is increased demand.
Aurobindo, Caraco, and Mylan cannot provide a reason for the shortage.
Teva discontinued tamsulosin 0.4 mg capsules in April 2014.
Par discontinued tamsulosin 0.4 mg capsules.
Article link:
163
Sodium Acetate Injection
August 15, 2014
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•
•
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American Regent has sodium acetate on shortage due to manufacturing delays.
American Regent has discontinued sodium acetate 2 mEq/mL 100 mL vials.
Fresenius Kabi has sodium acetate on shortage due to increased demand.
Hospira had sodium acetate on shortage due to manufacturing delays.
Baxter discontinued sodium acetate in June, 2008.
Article link:
Potassium Phosphate Injection
August 15, 2014
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•
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American Regent has potassium phosphate injection on back order due to
manufacturing delays.1,2
American Regent has issued a statement that all lots of potassium phosphate may
contain glass particles and filters must be used. Do not use if there are visible glass
particles and filter all other product.3,4
Hospira has potassium phosphate 15 mL vials on shortage due to increased demand.5
In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium
glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos
is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG.6
Fresenius Kabi, USA (formerly APP) launched potassium phosphate injection in
November 2013.7
Article link:
164
Phytonadione (Vitamin K) Injection
August 15, 2014
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•
•
Amphastar has vitamin K injection on shortage due to increased demand for the
product.
Hospira has vitamin K injection on shortage due to increased demand for the product.
Oral vitamin K is not affected by this shortage.
Article link:
Phenylephrine 2.5% and 10% Ophthalmic Solution
August 15, 2014
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•
•
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•
Akorn stopped manufacturing phenylephrine ophthalmic solution in April 2014 and
stopped distributing product on June 30, 2014.1
Alcon discontinued phenylephrine 2.5% ophthalmic solution with the Sandoz label in
April 2014.2
Alcon discontinued Mydfrin 2.5% ophthalmic solution in 2014. 2
Hub discontinued phenylephrine 2.5% and 10% ophthalmic solution in 2013.3
Phenylephrine 2.5% and 10% from Paragon BioTeck is the only FDA-approved
phenylephrine ophthalmic product. Paragon BioTeck supplies phenylephrine ophthalmic
solution 2.5% and 10% and this is distributed by Bausch & Lomb (a division of
Valeant).4,5
Article link:
165
Pantoprazole Tablets
August 15, 2014
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•
•
Actavis, Aurobindo, Mylan, Teva, and Torrent could not provide a reason for the
shortage.
Kremers Urban state the shortage is due to increased demand.
pantoprazole.
Article link:
Methylphenidate Hydrochloride
August 15, 2014
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•
•
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Mallinckrodt states the shortage was due to delay in obtaining raw materials. The
company has stopped using the trade name Methylin and all products are now
marketed as methylphenidate immediate-release or extended-release tablets with new
NDC numbers.
Sandoz states that the shortage is due to delay in obtaining raw materials.
Teva introduced generic methylphenidate extended release capsules (CD) in lateSeptember 2012, and these capsules are AB-rated to Metadate CD capsules.
UCB states methylphenidate IR tablets were on shortage due to supply and demand.
Actavis (formerly Watson) says the methylphenidate IR tablets were on shortage due to
supply constraints.
Article link:
166
Indomethacin Injection
August 15, 2014
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•
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•
Indomethacin for injection is on nationwide back order due to manufacturing issues.1,2
Lundbeck sold several products to Recordati in January 2013 including Indocin IV and
NeoProfen IV. Recordati is not currently manufacturing Indocin IV but NeoProfen is
available.3
indomethacin injection from Bedford in July 2014. West-Ward is not actively marketing
indomethacin injection at this time.2
Fresenius Kabi (formerly APP) had indomethacin injection on shortage due to increase
demand for the product.4
Article link:
Fluorouracil Injection
August 15, 2014
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•
•
•
Fresenius Kabi (formerly APP) states fluorouracil is on allocation to prevent excessive
purchases.1
Teva has fluorouracil on back order due to manufacturing issues.2
Mylan Institutional temporarily discontinued their fluorouracil injection in May 2013.3
Mylan Institutional acquired fluorouracil injection from Pfizer on December 6, 2013. 3
Article link:
167
Erythromycin Lactobionate Injection
August 15, 2014
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•
Hospira has Erythrocin 500 mg vials on shortage due to manufacturing delays.1
Hospira is the sole supplier of erythromycin lactobionate.
Article link:
Doxapram Injection
August 15, 2014
•
•
Ben Venue closed its plant in Bedford, Ohio in July 2014.
West-Ward had Dopram on shortage due to manufacturing delays
Article link:
Dopamine Injection
August 15, 2014
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•
•
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B Braun discontinued their dopamine premix in November 2012 due to raw material
supply issues.
available in stages as production resumes.
Baxter had dopamine on allocation due to increased demand.
168
Dexmedetomidine
August 15, 2014
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•
There are no other manufacturers of dexmedetomidine injection.
Article link:
Dacarbazine Injection
August 15, 2014
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•
Teva has dacarbazine on back order due to manufacturing delays.1
dacarbazine injection from Bedford in July 2014. West-Ward is not actively marketing
dacarbazine injection at this time.5
Article link:
Clonidine Injection
August 15, 2014
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•
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American Regent has clonidine injection temporarily unavailable due to manufacturing
delay.
X-Gen states the reason for the shortage is increased demand.
West-Ward states the reason for the shortage is manufacturing delay.
169
Article link:
Clindamycin Injection
August 15, 2014
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•
•
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Pfizer states the Cleocin Add-Vantage vials are on shortage due to manufacturing delays.
Hospira has clindamycin injection on shortage due to manufacturing delays.
Akorn launched clindamycin injection in June 2013.
Sandoz had clindamycin injection on shortage due to increased demand.
Sagent has clindamycin injection on shortage due to manufacturing delays.
Article link:
Ceftazidime Injection
August 15, 2014
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•
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Pfizer discontinued all of its ceftazidime injection products in late-November, 2011.
West-Ward discontinued all of its ceftazidime injection products in January 2012.
Hospira has ceftazidime on shortage due to manufacturing delays.
Covis purchased all rights to Fortaz from GlaxoSmithKline. Covis began changing NDC
numbers in December 2012.
Sagent had ceftazidime injection on shortage due to increased demand for the product.
WG Critical Care launched ceftazidime 1 gram vials in July 2013 and product is available
at wholesalers. Ceftazidime 2 gram and 6 gram presentations were launched in August
2013.
Article link:
170
Butorphanol Injection
August 15, 2014
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Apotex discontinued butorphanol injection in 2008.
Hospira states the shortage was due to manufacturing delays.
West-Ward discontinued butorphanol injection in early 2012.
Sandoz discontinued Stadol injection in 2010.
Article link:
Bupropion Hydrochloride 24 hour ER Tablets
August 15, 2014
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•
Global and Par state the reason for the shortage is increased demand for product.
Mylan cannot provide a reason for the shortage.
Article link:
Water-Miscible Oral Multiple Vitamins
August 18, 2014
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•
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Source CF could not provide a reason for the shortage.
Axcan Pharma discontinued ADEKs chewable tablets in May 2011.
Macoven discontinued AKEDamins in early-2014.
Standard multivitamins are not affected by this shortage.
Libertas launched softgel capsules in early-July 2014.
171
Article link:
Sterile Water Irrigation
August 18, 2014
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Baxter has sterile water for irrigation on shortage due manufacturing delays.1
BBraun only has product available for existing customers.2
Hospira only has product available for existing customers.3
Article link:
Sodium Chloride 0.9% Irrigation
August 18, 2014
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•
•
Baxter has 0.9% sodium chloride irrigation on shortage due manufacturing delays. 1
Article link:
Methylprednisolone Sodium Succinate Injection
August 18, 2014
•
Hospira discontinued all methylprednisolone sodium succinate products in January 2013
due to raw material issues.1
172
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Bedford discontinued methylprednisolone in May, 2011 to concentrate on the
manufacturing of other products.2
Pfizer had Solu-Medrol on shortage due to manufacturing delays.3
Fresenius Kabi (formerly APP) has methylprednisolone sodium succinate on shortage
due to priority of other medications.4
Article link:
Lactated Ringer's Irrigation
August 18, 2014
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•
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Baxter has lactated ringer’s on shortage due manufacturing delays.1
Article link:
Isoniazid Tablets
August 18, 2014
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•
Versapharm could not provide a reason for the shortage.
West-Ward discontinued isoniazid tablets in late-November 2013.
Article link:
173
Furosemide Injection
August 18, 2014
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•
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Fresenius Kabi (formerly APP) has furosemide injection on shortage due to increased
demand for the product.1
American Regent has furosemide injection on shortage due to manufacturing delays.3
Hospira states the shortage is due to manufacturing delays.5
Wockhardt has discontinued all furosemide injection presentations.6
Article link:
Doxycycline Hyclate Injection
August 18, 2014
•
•
Mylan Institutional states the shortage is due to supplier availability.
products from Bedford Laboratories in July 2014 including doxycycline injection.
Article link:
Bumetanide Injection
August 18, 2014
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•
•
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Baxter discontinued bumetanide 0.25 mg/mL 2 mL vial in early-2011.
West-Ward acquired several Baxter products including bumetanide in mid-2011.
Bumetanide was on shortage because demand exceeded supply.
Hospira had bumetanide on shortage due to manufacturing delays.
174
Article link:
Acetylcysteine Inhalation Solution
August 18, 2014
•
•
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•
American Regent has acetylcysteine inhalation on shortage due to manufacturing
delays.
Roxane Labs discontinued acetylcysteine inhalation solution in April 2014. The product
had previously been on shortage due to manufacturing delays.
Hospira has acetylcysteine inhalation solution on shortage due to manufacturing delay.
Fresenius Kabi (formerly APP) states the reason for the shortage was increased demand.
Article link:
Piperacillin Tazobactam Injection
August 19, 2014
•
•
•
Hospira has piperacillin/tazobactam on shortage due to manufacturing delays.
Pfizer has Zosyn on shortage due to manufacturing delays.
WG Critical Care states the reason for the shortage was increased demand.
Article link:
175
Olanzapine Injection
August 19, 2014
•
•
American Regent states the reason for the shortage is manufacturing delay.
Sandoz states the reason for the shortage is increased demand.
Article link:
Fludarabine Injection
August 19, 2014
•
•
•
•
•
•
•
•
Fresenius Kabi, USA (formerly APP) had fludarabine lyophilized powder for injection on
shortage due to focus on supplying solution for injection.1
Fresenius Kabi, USA had fludarabine solution for injection on shortage due to increased
demand.1
Teva had fludarabine on shortage due to manufacturing delays.2
Sagent had fludarabine on shortage due to manufacturing delays.3
Hospira had fludarabine on shortage due to manufacturing delays.4,5
Sandoz had fludarabine on back order due to manufacturing delays.6
Mylan Institutional temporarily discontinued fludarabine injection in late-April 2013.7
Genzyme discontinued Fludara in July, 2012.8
Article link:
176
Daunorubicin Hydrochloride Injection
August 19, 2014
•
•
daunorubicin injection and Cerubidine injection from Bedford in July 2014. West-Ward
is not actively marketing daunorubicin injection or Cerubidine injection at this time.1
Teva states daunorubicin was on back order due to manufacturing delays.2
Article link:
Carboplatin Solution for Injection
August 19, 2014
•
•
•
•
•
Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of
other products.1
Teva has carboplatin injection on shortage due to manufacturing delays.2,3,4
Fresenius Kabi has carboplatin on shortage due to increased demand for the product.5
Sandoz has carboplatin on shortage due to manufacturing delays.6
Sagent launched carboplatin in November 2013.7
Article link:
Caffeine Citrate Injection and Oral Solution
August 19, 2014
•
•
•
American Regent has caffeine citrate on shortage due to manufacturing delays.
Paddock discontinued caffeine citrate injection and oral solution in May 2014.
Sagent states the reason for the shortage is increased demand.
177
•
West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired Cafcit
from Bedford in July 2014. West-Ward is actively marketing Cafcit injection.
Article link:
Acyclovir Suspension
August 19, 2014
•
•
Hi-Tech discontinued acyclovir suspension in April 2014.
Actavis could not provide a reason for the shortage.
Article link:
Rocuronium Injection
August 20, 2014
•
•
•
•
•
•
Merck discontinued Zemuron 10 mL multidose vials in the 3rd Quarter of 2013. Merck
discontinued Zemuron 5 mL vials in June 2014.1
Mylan Institutional states the reason for the shortage was increased demand.2,3
Hospira had rocuronium on shortage due to manufacturing delays.4
Teva has rocuronium on shortage due to manufacturing delays.5
Fresenius Kabi and Sagent cited increased demand as the reason for this shortage.6,8
The Medicines Company launched rocuronium in early 2014.9
Article link:
178
Paclitaxel Injection
August 20, 2014
•
•
•
•
•
•
•
•
Fresenius Kabi (formerly APP) has paclitaxel on shortage due to increase demand for the
product.1
paclitaxel injection from Bedford in July 2014. West-Ward is not actively marketing
paclitaxel.2,3
Teva has paclitaxel on shortage due to manufacturing delays.4
Sandoz has paclitaxel on back order due to a raw material shortage.5
Hospira had paclitaxel on shortage due to increased demand.6,7
Sagent has paclitaxel on shortage due to increased demand.8
Pfizer launched paclitaxel 100 mg and 300 mg vials in March, 2012 and launched the 30
mg vials in April, 2012.9
Mylan Institutional acquired paclitaxel injection from Pfizer on December 7, 2013.9,10
Article link:
Oxacillin Sodium Injection
August 20, 2014
•
•
•
Auromedics states the reason for the shortage is increased demand.
Sagent states the reason for the shortage is manufacturing delay.
Sandoz states the reason for the shortage is difficulty obtaining the active
pharmaceutical ingredient.
Article link:
179
Nimodipine Capsules
August 20, 2014
•
•
•
Caraco cannot provide a reason for the shortage.
Heritage cannot provide a reason for the shortage.
Teva discontinued nimodipine capsules in early-March, 2013.
Article link:
Midazolam Injections
August 20, 2014
•
•
•
•
•
•
•
•
•
West-Ward acquired Baxter’s midazolam injection products in May, 2011.1
Ben Venue stopped production in its plant in Bedford, Ohio and closed in 2014.2
Hospira has midazolam on shortage due to manufacturing delays and demand
exceeding supply due to current market conditions.3
Hospira discontinued midazolam 5 mg/mL 1 mL iSecure syringes in July 2011.3
Fresenius Kabi (formerly APP) had midazolam on shortage due to increased demand.4
Due to low demand, Akorn is focusing on other medications that are in greater need of
supply.5
Caraco discontinued two midazolam presentations in 2014.7
midazolam injection.8
Medicines Company launched midazolam injection in early 2014.9
Article link:
180
Fluorescein sodium injection
August 20, 2014
•
•
Altaire Pharmaceuticals temporarily discontinued fluorescein and fluorescein lite
products. Altaire Pharmaceuticals could not provide a reason for the temporary
discontinuation.
Alcon could not provide a reason for the shortage.
Article link:
Famotidine Injection
August 20, 2014
•
•
•
•
•
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.1
West-Ward states the shortage is due to manufacturing delays.2
Oral famotidine products are not affected by this shortage.
Pfizer launched famotidine injections in March, 2012.3
Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.4
Article link:
Digoxin Injection
August 20, 2014
•
Article link:
181
Ephedrine Injection
August 20, 2014
•
Hospira discontinued ephedrine in March, 2011.
Article link:
Dimercaprol Injection
August 20, 2014
•
Akorn could not provide a reason for the shortage
Article link:
Diltiazem Injection
August 20, 2014
•
•
•
•
•
•
Ben Venue stopped product in its plant in Bedford, Ohio and closed in July 2014.
Hospira states the reasons for the shortage are manufacturing delays and increases in
demand.
West-Ward had diltiazem injection on shortage due to manufacturing delays caused by
increased demand due to current market conditions.
Akorn states the reason for the shortage is increased demand due to market conditions.
Teva discontinued all diltiazem presentations in March, 2011.
Biovail discontinued Cardizem Lyo-Ject in 2007 due to business reasons.
Article link:
182
Acyclovir Injection
August 20, 2014
•
•
•
Fresenius Kabi (formerly APP) is not manufacturing acyclovir lyophilized powder to
concentrate on supplying the solution for injection.1
AuroMedics introduced acyclovir injection in February 2014.3
Article link:
Vancomycin Hydrochloride Injection
August 21, 2014
•
•
•
•
•
•
•
•
Hospira has vancomycin on shortage due to increased demand.1
Fresenius Kabi (formerly APP) has vancomycin injection on shortage due to increased
demand.2
Sagent has vancomycin on shortage due to increased demand.8
Akorn has sold their vancomycin products to Pfizer and stopped distributing on April 29,
2011.3
Mylan Institutional acquired vancomycin injection from Pfizer on December 6, 2013.4, 6
Mylan Institutional (formerly Bioniche) has acquired multiple products from
Generamedix, including vancomycin hydrochloride.4,5
Mylan Institutional discontinued two vancomycin presentations in September 2013.4
Pfizer acquired multiple products from Akorn, including vancomycin hydrochloride in
early-May, 2011.3,6
Article link:
183
Sodium Chloride 0.45% Injection Bags
August 21, 2014
•
•
•
Baxter has 0.45% sodium chloride on shortage due to increased demand.1
BBraun had 0.45% sodium chloride on allocation due to increased demand. 2
Hospira cited increased demand as the reason for the shortage.3
Article link:
Prochlorperazine Edisylate Injection
August 21, 2014
•
•
Heritage launched prochlorperazine 5 mg/mL 2 mL vials in January 2014.2
Article link:
Pancuronium Injection
August 21, 2014
•
•
Teva discontinued their pancuronium presentations in May, 2010. 1
Hospira’s product is on back order due to manufacturing delays and retesting of raw
material. Hospira is the only manufacturer of pancuronium.2
Article link:
184
Fosphenytoin Injection
August 21, 2014
•
•
•
•
•
•
•
•
Akorn discontinued fosphenytoin injection in 2011.1
Fresenius Kabi recalled numerous lots of fosphenytoin due to particulate matter
potentially from glass delamination and consistent with glass particulates observed in
samples. Fresenius Kabi has a letter discussing the lot numbers and what to do with
affected product.2
American Regent discontinued fosphenytoin injection in late-2010.3
Bedford discontinued fosphenytoin in May, 2011 to concentrate on the manufacturing
of other products.4
Hospira states the shortage is due to manufacturing delays.5,6
Pfizer discontinued the Cerebyx 500 mg presentation in September, 2009 and the 1
gram presentation in early-February, 2010.7
Pfizer launched Cerebyx 2 mL and 10 mL vials in October 2013.7
Teva, Apotex, Baxter, GeneraMedix, and Wockhardt have discontinued their
fosphenytoin presentations.8-12
Article link:
Cyclosporine Injection
August 21, 2014
•
•
Perrigo acquired Paddock Laboratories in July 2011. Perrigo discontinued cyclosporine
injection in late-November, 2011.
cyclosporine injection from Bedford in July 2014. West-Ward is not actively marketing
cyclosporine injection.
Article link:
185
Cisplatin Injection
August 21, 2014
•
•
•
•
Fresenius states the shortage was due to increased demand and manufacturing delays.1
Mylan Institutional has cisplatin only available with short-dating.2
Teva is allocating cisplatin to prevent stockpiling.3
WG Critical Care is allocating product due to increased demand.4
Ceftriaxone Sodium Injection
August 21, 2014
•
•
•
•
•
Fresenius Kabi states the reason for the shortage is increased demand.
WG Critical Care states the reason for the shortage is increased demand.
Article link:
Cefotetan Disodium Injection
August 21, 2014
•
Fresenius Kabi states the reason for the shortage is manufacturing delay.
Article link:
186
Cefazolin Injection
August 21, 2014
•
•
•
•
Fresenius Kabi, BBraun, West-Ward, and WG Critical Care have cefazolin on shortage
due to increased demand.
Apotex and Sandoz have cefazolin on shortage due to manufacturing delays.
Hospira has cefazolin on shortage due to manufacturing delays and increased demand.
Sagent has cefazolin on shortage due to increased demand and shipping delays.
Article link:
Bleomycin Injection
August 21, 2014
•
•
•
Fresenius Kabi state bleomycin is on shortage due to increased demand.1
Hospira states bleomycin is in short supply due to manufacturing delays.2
Teva states bleomycin is on shortage due to increased demand.3
Article link:
Amiodarone Hydrochloride Injection
August 21, 2014
•
•
•
Hospira had amiodarone injection on shortage due to manufacturing delays.
Fresenius Kabi has amiodarone injection on shortage due to increased demand.
West-Ward stated the reason for the shortage is demand exceeding supply due to
current market conditions.
187
Article link:
Tranexamic Acid Injection
August 22, 2014
•
•
Fresenius Kabi (formerly APP) has tranexamic acid injection on shortage due to
X-Gen has tranexamic acid on shortage due to increased demand.
Article link:
Sumatriptan Succinate Injection
August 22, 2014
•
•
•
•
•
Sagent states the reason for the shortage is increased demand.
Par Sterile Products (formerly JHP) could not provide a reason for the shortage.
GlaxoSmithKline could not provide a reason for the shortage.
Pfizer has had Alsuma on shortage since September 2013 due to manufacturing issues.
Teva has temporarily suspended the production of sumatriptan injection.
Article link:
Sufentanil Injection
August 22, 2014
•
West-Ward has sufentanil on shortage due to manufacturing delays.1
188
•
•
Hospira has sufentanil on shortage due to manufacturing delays.2
Akorn could not provide a reason for the shortge.3
Article link:
BCG Vaccine Live Intravesical
August 22, 2014
•
•
•
Sanofi Pasteur states the reason for the shortage is manufacturing delay.1
Merck states the reason for the shortage is manufacturing delay.2
Merck states Tice BCG vaccine percutaneous for tuberculosis (Merck, NDC 00052-060302) is also affected because this product is manufactured at the same facility.2
Article link:
Sincalide Injection
August 25, 2014
•
•
Bracco Diagnostics has Kinevac on shortage due to manufacturing delays.
There are no approved alternatives to Kinevac for the labeled indications.
Article link:
Papaverine Injection
August 25, 2014
189
•
•
•
Bedford and Sandoz have discontinued their papaverine presentations.1,2
American Regent has papaverine on shortage due to manufacturing delays.3
American Regent is the sole supplier of papaverine.3
Article link:
190
NEW DRUGS COMING TO MARKET
PRODUCT
MFR
ROUTE
INDICATION
Dulaglutide
(Trulicity)
Inhaled
Technosphere®
Insulin (Afrezza)
Lilly
INJ (SC)
Type II diabetes
MannKind/Sanofi
Inhaled
insulin
Type 1 & 2 diabetes
Empagliflozin
and linagliptin
Boehringer
Ingelheim/ Eli Lilly
PO
Type II diabetes
Toujeo
Sanofi
INJ (SC)
Type 1 & 2 diabetes
Oritavancin
(Orbactiv)
The Medicines
Company
INJ (IV)
Gram positive
infections
Abacavir/
dolutegravir/
lamivudine
ViiV healthcare
PO
HIV
Ledipasvir/
sofosbuvir
Gilead
PO
Hepatitis C
Daclatasvir
Bristol-Myers
Squibb
PO
Hepatitis C
PHARMACOLOGY
GLP-1 receptor
agonist (once weekly)
Palm-sized inhaler
with single use
cartridges
Sodium-glucose
cotransporter-2
(SGLT2) inhibitor and
DPP-4 inhibitor
Long acting U300
basal insulin
Lipoglycopeptide that
inhibits cell wall
synthesis
Single tab combining
integrase inhibitor,
replication inhibitor,
nucleoside reverse
transcriptase
inhibitor
Fixed dose
combination of NS5A
protein inhibitor,
nucleotide NS5B
inhibitor
NS5A protein
inhibitor
MARKET
RELEASE
NDA filed
9/18/2013
FDA
approved 627-2014;
Launch
expected
early 2015;
Sanofi signed
marketing
agreement
8/14
NDA filed
4/14
NDA filed
7/14
FDA
approved
8/7/14;
Qualified
Infectious
Disease
Product
(QIDP)
designation
NDA filed
10/22/2013;
FDA action
date 10/14
NDA filed
2/14; Breakthrough
therapy
designation
granted 8/13;
priority
review; FDA
action date
10/10/14
NDA filed
4/14; triple
therapy
break-
191
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
Asunaprevir
Bristol-Myers
Squibb
PO
Hepatitis C
NS3 protease
inhibitor
Elvitegravir
Gilead
PO
HIV
Integrase inhibitor
ABT-450 (plus
ritonavir)
AbbVie
PO
Hepatitis C
Hepatitis C virus
(HCV) NS3/4A
protease inhibitor
(given with ritonavir
as booster)
Ombitasvir
(ABT-267)
AbbVie
PO
Hepatitis C
Hepatitis C virus
(HCV) NS5A inhibitor
MARKET
RELEASE
through
therapy
designation
(with
asunaprevir
& BMS
791325) for
chronic
Hepatitis C
NDA filed
4/14; triple
therapy
breakthrough
therapy
designation
(with
daclatasvir &
BMS 791325)
for chronic
hepatitis C
NDA filed
6/12. FDA
complete
response
letter
4/27/13. NDA
re-submitted
4/14. FDA
action date
10/4/14
All oral triple
therapy (with
ABT-267 and
ABT-333)
receives FDA
breakthrough
therapy
designation
5/13’ NDA
filed 4/22/14
All oral triple
therapy (with
ABT-450 and
ABT-333)
received FDA
breakthrough
192
PRODUCT
Dasabuvir (ABT333)
MFR
AbbVie
ROUTE
PO
PO
INDICATION
Hepatitis C
PHARMACOLOGY
Hepatitis C virus
(HCV) non-nucleoside
polymerase inhibitor
Protease inhibitor
and pharmacokinetic
enhancer
Omega-3 fatty acid
Darunavir and
cobicistat
Gilead
Epanova
Omthera
PO
Hypertriglyceridemia
Ceftolozane/
tazobactam
Cubist
INJ (IV)
Complicated Urinary
Tract Infections
(cUTI) and
complicated IntraAbdominal Infections
(cIAI)
Cephalosporin/betalactase inhibitor
combination
Peramavir
BioCryst
INJ (IV)
Influenza
Isavuconazole
Basilea
PO, IV
Treatment of
systemic and invasive
Candida and
Aspergillus infections
Cyclopentane
compound that
selectively inhibits
the influenza A and B
neuraminidase
enzyme
Binds and inhibits
ergosterol synthesis
by inhibiting CYP450dependant 14-alpha
sterol demethylase
HIV
MARKET
RELEASE
therapy
designation
5/13; NDA
filed 4/22/14
All oral triple
therapy (with
ABT-267 and
ABT-450)
receives FDA
breakthrough
therapy
designation
5/13; NDA
filed 4/22/14
NDA filed
4/14
FDA
approved
5/6/14;
Amarin filed
lawsuit that
may delay
launch
NDA filed 423-2014; FDA
fast track and
Qualified
Infectious
Disease
Product
(QIDP)
designation;
priority
review; FDA
action date
12-21-2014
NDA filed 122013; FDA
action date
12-23-2014
Orphan drug
status;
Qualified
Infectious
Disease
193
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
Pembrolizumab
(MK-3475,
Lambrolizumab)
Merck
INJ (IV)
Melanoma; NSCLC
Specifically targets
the “programmed
death” 1 (PD-1)
receptor
Olaparib
AstraZeneca
PO
Breast Cancer;
Ovarian Cancer
Poly-ADP-ribose
polymerase (PARP)
enzyme inhibitor
Panobinostat
(Faridak; LBH589)
Novartis
PO
Cutaneous T-cell
Lymphoma, CML,
MDS
Brexpiprazole
Otsuka
PO
Naloxegol
(Movantik)
Nektar/AstraZeneca
PO
Depression, ADHD,
schizophrenia
Opioid-induced
constipation
Secukinumab
(AIN-457)
Novartis
INJ (SC
and IV)
Novel and highly
potent histone
deacetylase (HDAC)
inhibitor that induces
cell death of tumor
cell lines but not
normal cells.
D2 dopamine partial
agonist
PEGylated tablet
formulation of
naloxol (an analogue
of naloxone)
Fully human
monoclonal antibody
targeting interleukin17 (IL-17)
Psoriatic arthritis,
plaque psoriasis
MARKET
RELEASE
Product
(QIDP)
designation
for
Apergillosis
12-2013;
NDA
submitted 72014
FDA breakthrough
therapy
designation
4-2013;
Rolling BLA
submitted 12014; FDA
action date
10-28-14
NDA filed 42014: FDA
priority
review; FDA
advisory
cmte voted
11-2 against
accelerated
approval 625-2014; FDA
action date
still listed as
10-3-2014
NDA filed 32014; FDA
priority
review with
action date
11-2014
NDA filed
7/14
NDA filed
9/13; FDA
action date
9/16/14
BLA
submitted
10/13
(plaque
194
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
Umeclidinium
bromide
(Incruse Ellipta)
GSK
INH
COPD
Muscarinic
acetylcholine (Ach)
receptor antagonist
Nintedanib
(Vargatef)
Boehringer
Ingelheim
PO
Idiopathic pulmonary
fibrosis, NSCLC,
ovarian cancer
Triple angiokinase
inhibitor acting
simultaneously on
VEGFR, FGFR, PDGFR
Albuterol multidose dry
powder inhaler
(Spiromax)
Zarzio (filgrastim
biosimilar)
Teva
INH
Reversible
obstructive airway
disease
Albuterol multi-dose
dry powder inhaler
(MDPI)
Sandoz
INJ (SC)
Blood cell stimulator;
neutropenia
Neupogen biosimilar
Asfotase
Enobia pharma
INJ (SC)
Hypophosphatasia
Recombinant fusion
protein that includes
catalytic domain of
human tissue nonspecific alkaline
phosphatase
(TNSALP)
Eliglustat
(Cerdelga)
Sanofi
PO
Gaucher’s disease
Ruconest
Salix
INJ (IV)
Hereditary
angioedema
Pirfenidone
(Esbriet)
InterMune
PO
Idiopathic pulmonary
fibrosis (IPF),
Partially inhibits the
enzyme
glucosylceramide
synthase
Complement C1r
inhibitor-the major
inhibitor of activated
Hageman factor,
plasmin and kallikrein
of the coagulation
pathway
Small molecule
tumor necrosis factor
MARKET
RELEASE
psoriasis);
FDA action
date
10/20/14
FDA
approved
4/30/14;
launch
planned for
4Q2014
NDA filed
7/14; orphan
drug, fast
track, priority
review, and
breakthrough
therapy
designation
NDA filed
7/14
BLA
submitted
7/14
(biosimilar
pathway)
FDA breakthrough
therapy
designation
5/28/13;
rolling BLA
initiated
4/25/14
NDA filed
12/13; FDA
priority
review 12/13
FDA
approved
7/17/14;
launch
planned for
late 2014
NDA
submitted
195
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
interstitial lung
disease
alpha (TNFalpha)inhibitor for
inhibition of collagen
synthesis; mitogenactivated protein
(MAP) kinase p38
inhibitor
Ferric citrate
(Zerenex)
Keryx
PO
Hyperphosphatemia
Small-molecule
phosphate binder
Alemtuzumab
(Lemtrada)
Sanofi
INJ(IV)
Multiple Sclerosis
Monoclonal antibody
that selectively
targets CD52, a
protein abundant on
T and B cells
Interferon-β
with PEG
(Plegridy)
Biogen Idec
INJ(SC)
Multiple Sclerosis
Hydrocodone ER
(HYD,
HydroContin)
Purdue
PO
Moderate to severe
pain
Peglyated version of
Avonex that allows
every other week
subcutaneous dosing
Hydrocodone
extended release
with abuse deterrent
properties; dosed
once daily
MNK-155
Mallinkrodt
PO
LP2086 (bivalent
recombinant)
Pfizer
INJ
(IM)
Moderate to
moderately severe
acute pain
Prevention of
meningitis B
Hydrocodone and
acetaminophen
extended release
MARKET
RELEASE
11/9; FDA
complete
response
5/10; FDA
orphan drug
status 2013;
NDA
resubmitted
5/27/14; FDA
breakthrough
therapy
designation
7/17/14
NDA filed
8/13; FDA
action date
extended to
9/7/14
FDA
complete
response
issued 12/13;
Sanofi
resubmitted
5/14;
response
expected
4Q2014
FDA
approved
8/16/14
NDA
submitted
4/14; FDA
priority
review; FDA
action date
10/14
NDA
submitted
5/14
FDA breakthrough
therapy
designation;
NDA
submitted
196
PRODUCT
Multicomponent
meningococcal
serogroup B
vaccine
(4CMenB or
Bexsero)
MFR
Novartis
ROUTE
INJ
(IM)
INDICATION
Prevention of
meningitis B
PHARMACOLOGY
Produced using
reverse vaccinology,
which decodes
genetic makeup of
MenB & selects
proteins that are
most likely to be
protective vaccine
candidates
MARKET
RELEASE
6/14
FDA breakthrough
therapy
designation;
NDA
submitted
6/14
197

July/August 2014

Transcription

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