July 2015 - PerformRx

Transcription

July 2015
Drug Information Update
Table of Contents
NEW GENERICS TO MARKET ........................................................................................................... 2
NEW DRUG ENTITIES....................................................................................................................... 4
NEW INDICATIONS (EXISTING DRUGS) ........................................................................................... 8
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ..................................................................... 9
STUDIES and RECENT TOPICS ........................................................................................................ 23
RECALLS ......................................................................................................................................... 30
CURRENT DRUG SHORTAGES ........................................................................................................ 49
NEW DRUGS COMING TO MARKET .............................................................................................. 97
Copyright© PerformRx, LLC 2015 All Rights Reserved
1
NEW GENERICS TO MARKET
GENERIC DRUG NAME
STRENGTH & DOSAGE
FORM
GENERIC
MANUFACTURER
BRAND NAME
APPROVAL
DATE
HYDROCORTISONE/IODOQUINOL/A
LOE
1.9 % - 1 %, CREAM
PACK
BOWYN LABS, LLC
VYTONE
06/02/2015
NAFTIFINE HCL
1%, CREAM (G)
RENAISSANCE PHA
NAFTIN
06/02/2015
PNV73/IRON,CARB&GLU/FA/DSS/D
HA
35 MG IRON - 1 MG - 50
MG - 300 MG, COMBO.
PKG
METHOD PHARMACE
CITRANATAL
ASSURE
06/04/2015
RISEDRONATE SODIUM
35 MG, TABLET
TEVA USA, ACTAVIS
PHARMA
ACTONEL
06/02/2015
RISEDRONATE SODIUM
30 MG, TABLET
TEVA USA, ACTAVIS
PHARMA
ACTONEL
06/02/2015
RISEDRONATE SODIUM
5 MG, TABLET
TEVA USA, ACTAVIS
PHARMA
ACTONEL
06/02/2015
SILDENAFIL CITRATE
10 MG/12.5 ML, VIAL
AUROMEDICS PHAR
REVATIO
06/02/2015
PNV72/IRON,CARB&GLU/FA/DSS/D
HA
90 MG IRON - 1 MG - 50
MG - 300 MG, COMBO.
PKG
METHOD PHARMACE
CITRANATAL 90
DHA
06/09/2015
TRAMADOL HCL
100 MG, CPBP 25-75
TRIGEN LABORATO
CONZIP
06/05/2015
TRAMADOL HCL
200 MG, CPBP 25-75
TRIGEN LABORATO
CONZIP
06/05/2015
TRAMADOL HCL
300 MG, CPBP 17-83
TRIGEN LABORATO
CONZIP
06/05/2015
DULOXETINE HCL
40 MG, CAPSULE DR
LUPIN PHARMA
IRENKA
06/08/2015
SALICYLIC ACID
28.50%, SOL-FILMER
KMM PHARMACEUTI.
ULTRASAL-ER
06/05/2015
HYDROXYZINE HCL
25 MG/Ml, VIAL
AMER. REGENT
HYDROXYZINE HCL
11/12/1987
HYDROXYZINE HCL
50 MG/Ml, VIAL
ROERIG,J.B.,
EDWARDS PHARM.,
AMER. REGENT
HYDROXYZINE HCL
03/03/1988,
03/11/1984,
11/12/1987
GLATIRAMER ACETATE
20 MG/ML, SYRINGE
SANDOZ
COPAXONE
06/19/2015
DEXMETHYLPHENIDATE HCL
20 MG, CPBP 50-50
TEVA USA, SANDOZ
FOCALIN XR
06/22/2015,
6/23/2015
LINEZOLID
600 MG, TABLET
TEVA USA
ZYVOX
06/23/2015
HYPOCHLOROUS ACID/SODIUM
CHLOR
0.01%, SPRAY
OCULUS INNOVATI
AVENOVA
06/22/2015
2
GENERIC DRUG NAME
STRENGTH & DOSAGE
FORM
GENERIC
MANUFACTURER
BRAND NAME
APPROVAL
DATE
FENOFIBRATE
120 MG, TABLET
GLOBAL PHARM
FENOGLIDE
06/19/2015
HYDROCODONE/ACETAMINOPHEN
10 mg-300 mg/15 mL,
SOLUTION
AKORN INC.
LORTAB
06/23/2015
PYRIDOSTIGMINE BROMIDE
180 MG, TABLET ER
ALVOGEN INC
MESTINON
06/29/2015
ASPIRIN/DIPYRIDAMOLE
25 MG-200 MG, CPMP
12HR
ROXANE LABS, TEVA
USA
AGGRENOX
06/30/2015,
07/01/2015
KETOCONAZOLE
2%, FOAM
PERRIGO CO.
EXTINA
08/29/2011
ALMOTRIPTAN MALATE
12.5 MG, TABLET
TEVA USA, PATRIOT
PHARMAC
AXERT
07/07/2015
ALMOTRIPTAN MALATE
6.25 MG, TABLET
TEVA USA, PATRIOT
PHARMAC
AXERT
07/07/2015
BEXAROTENE
75 MG, CAPSULE
MYLAN
TARGRETIN
07/09/2015
BIVALIRUDIN
250 MG, VIAL
HOSPIRA, SANDOZ
ANGIOMAX
07/30/2015,
07/07/2015
CAFFEINE/SODIUM BENZOATE
250 MG/Ml (125 MG/mL
caffeine), VIAL
AMER. REGENT
CAFFEINE AND
SODIUM
BENZOATE
02/16/1994
FLUOXYMESTERONE
10 MG, TABLET
UPSHER SMITH
ANDROXY
04/29/1984
MEMANTINE HCL
10 MG, TABLET
MYLAN, ACTAVIS
PHARMA,
NAMENDA
07/13/2015
MEMANTINE HCL
5 MG, TABLET
MYLAN, ACTAVIS
PHARMA,
NAMENDA
07/13/2015
MEMANTINE HCL
5 mg (28)-10 mg (21),
TAB DS PK
ACTAVIS PHARMA
NAMENDA
07/13/2015
BALSAM PERU/CASTOR OIL
87 MG-788 MG/GM,
OINT PACK
STRATUS PHARM
VENELEX
07/16/2015
FENTANYL CITRATE-0.9 % NACL/PF
10 mcg/mL, SYRINGE
PHARMEDIUM/OF
FENTANYL
CITRATE-0.9%
NACL
07/23/2015
PRAMIPEXOLE DI-HCL
3 MG, TAB ER 24H
PAR PHARM.
MIRAPEX ER
07/21/2015
3
NEW DRUG ENTITIES
DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
NARCOTIC ANTITUSSIVE1ST GENERATION
ANTIHISTAMINE
SEROTONINNOREPINEPHRINE
REUPTAKE-INHIB (SNRIS)
ANTIPSYCHOTICS,ATYPICA
L,DOPAMINE,&
SEROTONIN ANTAG
L,DOPAMINE,&
SEROTONIN ANTAG
L,DOPAMINE,&
SEROTONIN ANTAG
L,DOPAMINE,&
SEROTONIN ANTAG
TETRACYCLINES
PROMETHAZINECODEINE
PROMETHAZINE
HCL/CODEINE
6.25-10/5
IRENKA
DULOXETINE HCL
40 MG
DORYX
DOXYCYCLINE HYCLATE
50 MG
NARCOTIC ANTITUSSIVE1ST GENERATION
ANTIHISTAMINE
BARBITURATES
TUZISTRA XR
CODEINE POLI/CHLORPHENIR
POLIS
14.7-2.8/5
PHENOBARBITAL
PHENOBARBITAL
20 MG/5 ML
DILUENT PRODUCTS
DILUENT-MERCK
LIVE VIRUS VACC
DILUENT #1,LIV VIRUS
VAC(SWFI)
-
DILUENT PRODUCTS
DILUENT FOR YFVAX
DILUENT,YELLW FEV
VAC,MDV,NACL
0.9%
DILUENT PRODUCTS
DILUENT FOR YFVAX
DILUENT,YELLOW FEV
VAC,SD,NACL
0.9%
PRENATAL VITAMIN
PREPARATIONS
PEDIATRIC VITAMIN
PREPARATIONS
PEDIATRIC VITAMIN
PREPARATIONS
PKU TX AGENT-COFACTOR
OF PHENYLALANINE
HYDROXYLASE
BETA-ADRENERGIC AND
GLUCOCORTICOID
TRISTART DHA
PRENATAL NO.93/IRON/FA
#9/DHA
PEDI MULTIVIT #90 WFLUORIDE
PEDI MULTIVIT #90 WFLUORIDE
SAPROPTERIN
DIHYDROCHLORIDE
31-1-200 MG
FLUTICASONE/VILANTEROL
200-25 MCG
NOTES
5 mL in 1 CUP
NEW STRENGTH
INVEGA TRINZA
PALIPERIDONE PALMITATE
273 MG/.875
New Formulation
INVEGA TRINZA
410/1.315
New Formulation
INVEGA TRINZA
546 MG/1.75
New Formulation
INVEGA TRINZA
819/2.625
New Formulation
POLY-VI-FLOR FS
POLY-VI-FLOR FS
KUVAN
BREO ELLIPTA
New
Strength/Dosage
Form
New Combination
0.25 MG
0.5 MG
5 mL in 1 CUP
Will not process
until pricing is
provided
Will not process
until pricing is
provided
Will not process
until pricing is
provided
New Combination
New Strength
New Strength
500 MG
New Strength
New Strength
4
DESCRIPTION
BRAND NAME
GENERIC NAME
PROTECTIVES
BEAU RX
TOPICAL ANTIINFLAMMATORY
STEROIDAL
ANTINEOPLASTICS
ANTIBODY/ANTIBODYDRUG COMPLEXES
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NARCO
LEPSY
ANTISEBORRHEIC AGENTS
DERMACINRX
SILAPAK
DI-ME
SILOX/DIMETHIC/HEXAMETH
Y
TRIAMCINOLONE
ACET/DIMETHICONE
UNITUXIN
DINUTUXIMAB
STRENGTH
NOTES
New Combination
0.1%-5%
New Combination
3.5 MG/ML
New Entity
RITALIN LA
METHYLPHENIDATE HCL
60 MG
OVACE PLUS
SULFACETAMIDE SODIUM
9.8%
PLATELET AGGREGATION
INHIBITORS
TOPICAL SULFONAMIDES
KENGREAL
CANGRELOR TETRASODIUM
50 MG
AVAR LS
SULFACETAMIDE
SODIUM/SULFUR
10 %-2 %
TOPICAL SULFONAMIDES
AVAR
SULFACETAMIDE
SODIUM/SULFUR
9.5 %-5 %
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
ANGIOTENSIN RECEPTNEPRILYSIN INHIBITOR
COMB(ARNI)
COMB(ARNI)
COMB(ARNI)
CYSTIC FIBROSIS-CFTR
POTENTIATOR &
CORRECTOR COMB.
OXAZOLIDINONES
FLUZONE QUAD
2015-2016
FLUZONE QUAD
PEDI 2015-2016
FLUZONE QUAD
2015-2016
FLUZONE QUAD
2015-2016
FLUZONE 20152016
FLUZONE HIGHDOSE 2015-2016
ENTRESTO
FLU VACCINE QS 2015-16
(6MOS+)
FLU VACC QS 2015 (635MOS)/PF
FLU VACC QS 201516(36MOS+)/PF
FLU VACC QS 201516(36MOS+)/PF
FLU VACCINE TS 2015-16(6
MOS+)
FLU VACC TS 2015-16
(65YR+)/PF
SACUBITRIL/VALSARTAN
60MCG/.5ML
30MCG/0.25
60MCG/.5ML
60MCG/.5ML
45MCG/.5ML
180MCG/0.5
New
Strength/Dosage
Form
New Strength
New Entity
New
Strength/Dosage
Form
New
Strength/Dosage
Form
New Formulation
New Formulation
New Formulation
New Formulation
New Formulation
New Formulation
24 MG-26MG
New Combination
ENTRESTO
49 MG-51MG
New Combination
ENTRESTO
ORKAMBI
LUMACAFTOR/IVACAFTOR
97MG103MG
New Combination
200-125MG
New Combination
LINEZOLID-0.9%
NACL
LINEZOLID-0.9% SODIUM
CHLORIDE
600MG/300
New Formulation
5
DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
FLUVIRIN 20152016
FLUVIRIN 20152016
FLUCELVAX 20152016
FLUZONE
INTRADERM
QUAD 2015-16
FLUBLOK 20152016
FLULAVAL QUAD
2015-2016
PRESTALIA
FLU VACCINE TS 20152016(4YR+)
FLU VACCINE TS201516(4YR+)/PF
FLU VACC TS 15-16
(18+)CELL/PF
FLU VACC QS 2015 (1864YRS)/PF
45MCG/.5ML
FLU VAC TV 2015(18
YR+)RCM/PF
FLU VACCINE QS 201516(36MOS+)
PERINDOPRIL
ARG/AMLODIPINE BES
135MCG/0.5
INFLUENZA VIRUS
VACCINES
INFLUENZA VIRUS
VACCINES
ACE INHIBITOR/CALCIUM
CHANNEL BLOCKER
COMBINATION
CHANNEL BLOCKER
COMBINATION
CHANNEL BLOCKER
COMBINATION
ANTIPSYCHOTICS, ATYP,
D2 PARTIAL AGONIST/5HT
MIXED
MIXED
MIXED
MIXED
MIXED
MIXED
KERATOLYTICS
PRESTALIA
PRESTALIA
REXULTI
45MCG/.5ML
45MCG/.5ML
NOTES
New Formulation
New Formulation
New Formulation
36MCG/.1ML
New Formulation
60MCG/.5ML
New Formulation
New Formulation
14MG-10MG
New Combination
PERINDOPRIL
ARG/AMLODIPINE BES
3.5-2.5 MG
PERINDOPRIL
ARG/AMLODIPINE BES
7 MG-5 MG
BREXPIPRAZOLE
0.25 MG
New Combination
New Combination
New Entity
REXULTI
BREXPIPRAZOLE
0.5 MG
New Entity
REXULTI
BREXPIPRAZOLE
1 MG
New Entity
REXULTI
BREXPIPRAZOLE
2 MG
New Entity
REXULTI
BREXPIPRAZOLE
3 MG
New Entity
REXULTI
BREXPIPRAZOLE
4 MG
New Entity
CARB-O-PHILIC
UREA
40 %
TOPICAL ANTIINFLAMMATORY, NSAIDS
PEDIATRIC VITAMIN
PREPARATIONS
DERMACINRX
LEXITRAL
TEXAVITE LQ
DICLOFENAC/CAPSICUM
1.5-0.025%
7-.25MG/ML
EMOLLIENTS
ALEVICYN
ANTIPRURITIC SG
PED
MULTIVIT#108/IRON/FLUORI
DE
EMOLLIENT COMBINATION
NO.60
New Strength and
Dosage Form
New Combination
New Combination
-
New Combination
6
DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
ACNE AGENTS,TOPICAL
EPIDUO FORTE
0.3 %-2.5%
WOUND HEALING
AGENTS, LOCAL
DERMACINRX
SURGICAL
PHARMAPAK
SILMANIX
ADAPALENE/BENZOYL
PEROXIDE
MUPIROCIN/CL-HEX
GL/DMC/SILICO
IRRITANTS/COUNTERIRRITANTS
CAPSAICIN/MENTHOL/HISTA
MINE
NOTES
New Strength
2 %-4 %-5%
New Combination
0.0375%-3%
New Combination
7
NEW INDICATIONS (EXISTING DRUGS)
DRUG
NEW INDICATION
DATE OF APPROVAL
LINKS
LENVIMA®
ADVANCED AND/OR
METASTATIC RENAL CELL
CARCINOMA
RELAPSED MULTIPLE
MYELOMA
UPPER LIMB SPASTICITY IN
ADULTS
June 29, 2015
Lenvima® [package insert].
Eisai Co., Ltd June 2015
July 24, 2015
Kyprolis® [package insert].
Amgen July 2015
Dysport® [package insert].
Ipsen July 2015
KYPROLIS®
DYSPORT®
July 16, 2015
8
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication Permanent Skin Color Changes
[Posted 06/24/2015]
ISSUE: FDA is warning that permanent loss of skin color may occur with use of the Daytrana
patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder
(ADHD). FDA added a new warning to the drug label to describe this skin condition, which is
known as chemical leukoderma. See the FDA Drug Safety Communication for photos of
chemical leukoderma.
Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated
exposure to specific chemical compounds. The condition is not physically harmful, but it is
disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches
in diameter. This condition is not thought to be reversible, which may cause emotional distress.
BACKGROUND: The Daytrana patch treats ADHD by working to increase attention and decrease
restlessness in children and adolescents who are overactive, cannot concentrate for very long,
or are easily distracted and impulsive.
RECOMMENDATION: Patients or their caregivers should watch for new areas of lighter skin,
especially under the drug patch, and immediately report these changes to their health care
professionals. Patients should not stop using the Daytrana patch without first talking to their
health care professionals. FDA recommends that health care professionals consider alternative
treatments for patients who experience these skin color changes.



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
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
SOURCE: U.S. Food and Drug Administration (FDA)
ARTICLE LINK:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu
cts/ucm452595.htm
9
FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop
Patient Ventilation
[Posted 07/01/2015]
ISSUE: FDA is providing notification of a Class I recall of FLOW-i Anesthesia Systems by Maquet.
The firm has received several complaints where patient cassettes, which are the center of gas
flow in the system, have come loose. The patient cassette locking device may accidentally
release the patient cassette from its mount when users perform a change of patient tubings or
when the CO2 absorber is replaced. This may cause anesthesia gas to leak and could prevent
the ventilator from providing breathing support if not corrected immediately.
The firm has received 10 foreign reports this device has malfunctioned; no injuries or
deathshave been reported.
BACKGROUND: The Flow-i Anesthesia System administers anesthesia while providing
ventilation to patients with no or limited ability to breathe. The system is used in hospitals, for
use in a range of patients from neonatal to adult.
RECOMMENDATION: A Maquet Service representative will contact consignees to arrange
replacement of the FLOW-i Anesthesia System patient cassette locking device.
For questions regarding this field action, please contact a Maquet Service Representative or
Maquet Technical Support at 1-888-627-8383 (Press option 3, followed by option 1 and then
option 1 again), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EST.



ARTICLE LINK:
cts/ucm453524.htm
10
Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety,
Effectiveness and Quality
[Posted 07/01/2015]
ISSUE: FDA announced its intention to take enforcement action against companies that
manufacture and/or distribute certain unapproved prescription ear drop products (known as
otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved
prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and
have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these
products do not disclose that they lack FDA approval, and health care professionals may not be
aware of their unapproved status.
Unapproved prescription otic drug products are frequently given to young children suffering
from ear infections and other conditions that cause ear pain and swelling. Patients taking
unapproved drugs may be at greater risk because there is no proven safety or effectiveness
information. These products may be contaminated or manufactured incorrectly, which could
result in patients receiving the wrong dose, even when administered according to the labeled
directions for use.
Unapproved prescription otic drug products containing the following ingredients are covered by
this action:
•benzocaine
•benzocaine and antipyrine
•benzocaine, antipyrine, and zinc acetate
•benzocaine, chloroxylenol, and hydrocortisone
•chloroxylenol and pramoxine
•chloroxylenol, pramoxine, and hydrocortisone.
BACKGROUND: FDA informed the companies that they must stop manufacturing these
unapproved prescription otic products or be subject to enforcement actions, including seizure,
injunction and/or criminal proceedings. Today’s action does not affect FDA-approved
prescription otic products, or legally marketed otic products sold over-the-counter.
RECOMMENDATION: Consumers who believe they are using unapproved prescription ear
drops should contact their health care provider to discuss alternatives.



11
ARTICLE LINK:
cts/ucm453430.htm
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating
Potential Risk of Serious Side Effects
[Posted 07/01/2015]
ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs
and colds in children under 18 years because of the potential for serious side effects, including
slowed or difficult breathing.
Children, especially those who already have breathing problems, may be more susceptible to
these serious side effects. In 2013, FDA warned against using codeine in children who recently
had surgery to remove their tonsils and/or adenoids.
In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used
to treat cough and cold in children under 12 years and that codeine is not recommended in
children and adolescents between 12 and 18 years who have breathing problems, including
those with asthma and other chronic breathing problems.
FDA will continue to evaluate this safety issue and will consider the EMA recommendations.
Final conclusions and recommendations will be communicated when the FDA review is
complete.
BACKGROUND: Codeine is a specific type of narcotic medicine called an opioid that is used to
treat mild to moderate pain and also to reduce coughing. It is usually combined with other
medications in prescription and over-the-counter (OTC) cough-and-cold medicines.
RECOMMENDATION: Parents and caregivers who notice any signs of slow or shallow breathing,
difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving
their child codeine and seek medical attention immediately by taking their child to the
emergency room or calling 911. Parents and caregivers should always read the product label to
find out if a medicine contains codeine and talk with their child’s health care professional or a
pharmacist if they have any questions or concerns. Health care professionals should continue
to follow the recommendations in the drug labels and use caution when prescribing or
recommending codeine-containing cough-and-cold medicines to children.


12

ARTICLE LINK:
cts/ucm453379.htm
Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke
[Posted 07/09/2015]
ISSUE: FDA is strengthening an existing label warning that non-aspirin nonsteroidal antiinflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs
comprehensive review of new safety information, FDA is requiring updates to the drug labels of
all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts
labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart
attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts
labels. See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal
anti-inflammatory drug products.
Prescription NSAID labels will be revised to reflect the following information:
 The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID.
The risk may increase with longer use of the NSAID.
 The risk appears greater at higher doses.
 It was previously thought that all NSAIDs may have a similar risk. Newer information
makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs;
however, this newer information is not sufficient for us to determine that the risk of any
particular NSAID is definitely higher or lower than that of any other particular NSAID.
 NSAIDs can increase the risk of heart attack or stroke in patients with or without heart
disease or risk factors for heart disease. A large number of studies support this finding,
with varying estimates of how much the risk is increased, depending on the drugs and
the doses studied.
 In general, patients with heart disease or risk factors for it have a greater likelihood of
heart attack or stroke following NSAID use than patients without these risk factors
because they have a higher risk at baseline.
 Patients treated with NSAIDs following a first heart attack were more likely to die in the
first year after the heart attack compared to patients who were not treated with NSAIDs
after their first heart attack.
 There is an increased risk of heart failure with NSAID use.
13
BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to
death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections
of the prescription drug labels. Since then, FDA reviewed a variety of new safety information on
prescription and OTC NSAIDs, including observational studies, a large combined analysis of
clinical trials, and other scientific publications. These studies were also discussed at a joint
meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory
Committee held on February 10-11, 2014.
RECOMMENDATION: Patients and health care professionals should remain alert for heartrelated side effects the entire time that NSAIDs are being taken. Patients taking NSAIDs should
seek medical attention immediately if they experience symptoms such as chest pain, shortness
of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.



ARTICLE LINK:
cts/ucm454141.htm
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market
Withdrawal - Difficulties in Administration
[Posted 07/14/2015]
ISSUE: In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of
Calcium Chloride Intravenous Infusion 10% w/v, packaged in 10 mL prefilled syringes. In June
2015, Mylan Institutional issued a second notification of the market withdrawal. FDA has
recently become aware that some units of this drug may still be on the market. Please check
your inventory and crash boxes, quarantine and discontinue distribution and use of affected
lots.
BACKGROUND: Calcium Chloride Intravenous Infusion 10% w/v is used as part of the
resuscitation procedure following a cardiac arrest and for the treatment of low calcium levels. It
is also used for arrhythmias associated with hypocalcaemia, hyperkalaemia or
hypomagnesaemia. Because of the use of Calcium Chloride Intravenous Infusion prefilled
syringes in emergency situations and its use as a lifesaving drug, difficulty in the administration
14
of the drug could create a potential risk by prohibiting or delaying the administration of the
medication.
RECOMMENDATION: Immediately examine your inventory and crash boxes, quarantine and
discontinue distribution and use of these lots. If you have the affected product, please contact
Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
In addition, if you have further distributed the affected product, please identify your customers
and notify them at once of this market withdrawal. The customer should be instructed to
contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
Additionally, Stericyle will notify your retail level customers that received the affected lots.
Provide a list of customers via Microsoft Excel file to [email protected] within 10
business days.



ARTICLE LINK:
cts/ucm454836.htm
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in
Infants and Newborns
[Posted 07/16/2015]
ISSUE: FDA is warning that a serious lung condition called pulmonary hypertension, which is
high pressure in the blood vessels leading to the lungs, has been reported in infants and
newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary
hypertension resolved or improved after Proglycem was stopped. FDA is continuing to
investigate this safety issue and will determine whether changes are needed in the Proglycem
prescribing information.
BACKGROUND: FDA identified 11 cases of pulmonary hypertension in infants and newborns
treated with diazoxide, the active ingredient in Proglycem, since the drug was approved in
1973.
RECOMMENDATION: Proglycem is usually given in the hospital, and health care professionals
should closely monitor babies receiving it, especially those with risk factors for pulmonary
15
hypertension such as meconium aspiration syndrome, respiratory distress syndrome, transient
tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital
heart disease. Stop Proglycem treatment if pulmonary hypertension is identified.
Parents and caregivers of any child receiving Proglycem should watch for signs of difficulty
breathing such as flaring nostrils, grunting, unusual movement of their child’s chest, rapid
breathing, difficulty feeding, or a bluish color of the lips or skin. Immediately alert your child’s
health care professionals if you see any of these signs, and talk to them if you have any
questions or concerns about Proglycem.



ARTICLE LINK:
cts/ucm455125.htm
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate
Matter
[Posted 07/20/2015]
ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV)
solutions to the hospital/user level due to the potential presence of particulate matter. The
particulate matter in each case was determined to be an insect and was identified as a result of
a customer complaint. The matter was identified prior to patient administration and there have
been no adverse events associated with this issue reported to Baxter.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result
in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs
such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and
inflammation in tissues and organs.
This recall affects Lot Numbers P319921 and P327635.
BACKGROUND: The lots being recalled were distributed to customers and distributors in the
United States between October 7, 2014 and July 14, 2015.
16
RECOMMENDATION: Baxter is directing customers not to use product from the recalled lots.
Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare
Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m.
and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday
through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at
[email protected]. Consumers should contact their physician or healthcare provider if
they have experienced any problems that may be related to using these drug products.



ARTICLE LINK:
cts/ucm455421.htm
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy:
Recall - Lack of Sterility Assurance
[Posted 07/24/2015]
ISSUE: Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile
compounded drugs which are unexpired to the consumer level due to lack of sterility
assurance.The company has not received any reports of product contamination or adverse
events to date, and is issuing this voluntary recall out of an abundance of caution following a
recent inspection which identified an issue with sterility assurance. If there is contamination in
products intended to be sterile, patients are at risk of serious infections which may be life
threatening.
BACKGROUND: The recalled products were made from 7/21/2014 through 7/21/2015, and
dispensed to patients or distributed to physicians for further administering to patients in the
states of Arizona, Idaho, Florida, Oregon, Texas, and Washington. All recalled products have a
label that includes the pharmacy name and the name of the compounded drug product. The
recall does not pertain to any non-sterile compounded medications prepared by the pharmacy
or to products compounded after July 21, 2015.
17
RECOMMENDATION: The pharmacy has begun notifying its patients by telephone, fax,
electronic mail and/or regular mail of this recall. Users or recipients of these products should
immediately discontinue use and return the recalled unexpired products.
To return product or request assistance related to this recall, users should call 509-764-2314,
Monday through Friday, from 8:30 a.m. to 12:30 p.m. and 1 to 5:30 p.m. PDT.; Consumers
should contact their physician or health care provider if they have experienced any problems
that may be related to taking these drug products.



ARTICLE LINK:
cts/ucm455931.htm
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety
Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use
[Posted 07/27/2015]
ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadoliniumbased contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in
the medical literature have reported that deposits of GBCAs remain in the brains of some
patients who undergo four or more contrast MRI scans, long after the last administration. It is
unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
FDA, including its National Center for Toxicological Research (NCTR), will study this possible
safety risk further. FDA is working with the research community and industry to understand the
mechanism of gadolinium retention and to determine if there are any potential adverse health
effects. Based on the need for additional information, at this time, FDA is not requiring
manufacturers to make changes to the labels of GBCA products.
BACKGROUND: After being administered, GBCAs are mostly eliminated from the body through
the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Recent
studies conducted in people and animals have confirmed that gadolinium can remain in the
brain, even in individuals with normal kidney function. Available information does not identify
any adverse health effects.
18
RECOMMENDATION: To reduce the potential for gadolinium accumulation, health care
professionals should consider limiting GBCA use to clinical circumstances in which the
additional information provided by the contrast is necessary. Health care professionals are also
urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.
Patients, parents, and caregivers should talk to their health care professionals if they have any
questions about the use of GBCAs with MRIs. This issue affects only GBCAs; it does not apply to
other types of scanning agents used for other imaging procedures, such as those that are
iodine-based or radioisotopes.



ARTICLE LINK:
cts/ucm456012.htm
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines:
Recall - Particulate Matter
[Posted 07/27/2015]
ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil
(fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate
matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil
crystals. Administration of an intravenous product with particulate matter has the potential to
result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death,
which may be life-threatening if vital organs are affected. To date, Teva has not received any
reports of adverse events related to this recall. See the press release for product lot numbers
affected by this recall.
BACKGROUND: Adrucil Injection is used in the palliative management of carcinoma of the
colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages.
RECOMMENDATION: Teva is arranging for impacted product to be returned to Inmar. Anyone
with an existing inventory of the recalled lots should stop use and distribution, and quarantine
the product immediately. Customers should notify all users in their facility. Customers who
19
have further distributed the recalled product should notify any accounts or additional locations
which may have received the recalled product and instruct them if they have redistributed the
product to notify their accounts, locations or facilities to the user level.



ARTICLE LINK:
cts/ucm456114.htm
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name
Confusion
[Posted 07/30/2015]
ISSUE: FDA is warning health care professionals and patients that reports of confusion between
the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the
wrong medication being prescribed or dispensed. FDA determined that the main reason for the
confusion between these two medications is the similarity of their brand (proprietary) names.
None of the reports indicates that a patient ingested the wrong medication; however, reports
of prescribing and dispensing errors continue.
BACKGROUND: Brintellix (vortioxetine) is used to treat a certain type of depression called
major depressive disorder (MDD) in adults. It is in a class of antidepressants called selective
serotonin reuptake inhibitors (SSRIs). Brilinta (ticagrelor) is an antiplatelet, anti-blood clotting
medication used to lower the risk of having another heart attack, or dying from a heart problem
after a heart attack or severe chest pain.
RECOMMENDATION: Health care professionals can reduce the risk of name confusion by
including the generic (established) name of the medication, in addition to the brand name, and
the indication for use when prescribing these medications. Patients should check their
prescriptions to ensure that the correct medication was dispensed. See the FDA Drug Safety
Communication for more detailed recommendations

20


ARTICLE LINK:
cts/ucm456569.htm
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall Potential For Leaking Containers, Particulate Matter and Missing Port
[Posted 07/31/2015]
ISSUE: Baxter International Inc. announced a voluntarily recall of one lot of intravenous (IV)
solution to the hospital/user level due to the potential for leaking containers, particulate matter
and missing port protectors. Leaking containers, particulate matter and missing port protectors
could result in contamination of the solution. If not detected, this could lead to a bloodstream
infection or other serious adverse health consequences. Injecting a product containing
particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels,
which can result in stroke, heart attack or damage to other organs such as the kidney or liver.
There is also the possibility of allergic reactions, local irritation and inflammation in tissues and
organs.
BACKGROUND: The lot being recalled was distributed to customers and distributors nationwide
between January 22, 2015 and February 12, 2015. This recall affects the following lot Number:
C964601, NDC: 0338-0049-03; Expiration Date: 04/30/2016
RECOMMENDATION: Customers were notified via letter that they should not use product from
the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter
Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours
of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for
replacement.



21
ARTICLE LINK:
cts/ucm456793.htm
22
STUDIES and RECENT TOPICS
Biohackers Aim To Make Homebrew Insulin, But Don't Try It Yet
July 15, 2015
Might people with diabetes someday be able to brew their own insulin for free at home, just as
with beer? The answer may be yes, but whether it's a good idea is another question.
Article link:
http://www.npr.org/sections/health-shots/2015/07/15/422935288/biohackers-aim-to-makehomebrew-insulin-but-dont-try-it-yet
Antidepressants And Painkillers Together May Raise The Risk Of Brain Bleeds
July 15, 2015
A new study in the journal The BMJ finds that the risk of intracranial hemorrhage – bleeding
that occurs in or around the brain – is increased when one combines antidepressants with nonsteroidal anti-inflammatory drugs (NSAIDS) like ibuprofen or naproxen. Since depression and
chronic pain often go hand-in-hand, and millions of people may take the two meds together,
the study results are particularly relevant. It’s important to note, however, that this study
looked only at prescription NSAIDs, so doses may have been higher than what one might take
with an over-the-counter versions. Still, the results raise questions about whether it’s advisable
to combine the two drugs over the long term, or at all.
Article link:
http://www.forbes.com/sites/alicegwalton/2015/07/15/antidepressants-and-painkillerstogether-may-raise-the-risk-of-brain-bleeds/
High blood pressure danger equal for slim and obese alike
July 16, 2015
Though previous research has suggested high blood pressure may be more dangerous for
thinner people, a new study finds the cardiovascular disease risks are similar – and high - for
the lean, overweight and the obese. “Some studies done in the past 30 years suggested that for
the adverse outcomes associated with hypertension – such as heart attacks and stroke – lean or
normal weight people with hypertension had worse outcomes than overweight or obese people
with hypertension,” said lead author Laura A. Colangelo of the Feinberg School of Medicine at
Northwestern University in Chicago.
Article link:
23
http://www.reuters.com/article/2015/07/16/us-health-hypertension-weightidUSKCN0PQ1QC20150716
American Health Packaging pulls thousands of Wockhardt-made products from the
market
July 16, 2015
Company initiates 13 recalls of 6 products made by Indian drugmaker India's Wockhardt
recently disclosed that the FDA was not happy that it had continued to sell in the U.S. products
that it had manufactured at two plants before the agency banned them. As a result, the Indian
drugmaker said it was going to have to recall anything left in the U.S. made at those facilities.
That burden has fallen in part to American Health Packaging, a subsidiary of
AmerisourceBergen, which has issued more than a dozen recalls of 6 products in different
doses.
Article link:
http://www.fiercepharmamanufacturing.com/story/american-health-packaging-pullsthousands-wockhardt-made-products-market/2015-07-16
Biogen Reports Another Tecfidera PML Case
July 16, 2015
There's been a second case of progressive multifocal leukoencephalopathy (PML) with dimethyl
fumarate (Tecfidera) for multiple sclerosis, a Biogen spokesperson confirmed. The company
said it reported the case -- which wasn't fatal -- to regulators including the FDA but would not
specify where the case occurred.
Article link:
http://www.medpagetoday.com/Neurology/MultipleSclerosis/52622
Serious Lung Problem Seen in Babies Receiving Proglycem
July 16, 2015
The FDA has identified 11 cases of pulmonary hypertension in infants and newborns treated
with diazoxide (Proglycem). In all reported cases, the serious lung condition resolved or
improved after the low blood sugar treatment was stopped.The FDA is investigating this issue
to determine whether changes to Proglycem’s prescribing information are warranted.
Article link:
http://www.pharmacytimes.com/product-news/serious-lung-problem-seen-in-babiesreceiving-proglycem
24
Vitamin B12 Supplements May Not Help Some Seniors
July 16, 2015
Vitamin B12 supplements are known to benefit seniors with severe B12 deficiency, but they
may not help those who are just moderately deficient, a new study suggests. "Many people
may be taking vitamin B12 supplements on a regular basis, and it has been thought they would
enhance function in older people," said study author Dr. Alan Dangour, of the London School of
Hygiene & Tropical Medicine. "Our study found no evidence of benefit for nervous system or
cognitive function from 12 months of supplementation among older people with moderate
vitamin B12 deficiency."
Article link:
http://consumer.healthday.com/senior-citizen-information-31/misc-aging-news-10/benefitsof-b12-supplements-not-seen-in-seniors-with-moderate-vitamin-deficiency-701014.html
Aspirin Use Common Among Americans With Heart Trouble
July 16, 2015
About seven in 10 Americans who've had heart disease or a stroke regularly take aspirin, U.S.
health officials report. Low-dose aspirin is promoted as an inexpensive, effective way to prevent
cardiovascular disease. Researchers from the U.S. Centers for Disease Control and Prevention
wanted to know who takes it regularly (daily or every other day) and why.
Article link:
http://consumer.healthday.com/general-health-information-16/aspirin-news-46/aspirin-usecommon-for-americans-with-heart-history-701424.html
Gilead Limits Enrollment in its Hep C Patient Program to Pressure Insurers
July 16, 2015
In a bid to push back against payers, Gilead Sciences is limiting enrollment to its patient
assistance program for hepatitis C drugs, which helps people obtain the Sovaldi and Harvoni
treatments when they lack sufficient insurance coverage or the financial wherewithal to get the
medicines otherwise.
Article link:
http://blogs.wsj.com/pharmalot/2015/07/16/gilead-limits-enrollment-in-its-hep-c-patientprogram-to-pressure-insurers/
25
FDA: More basic science research needed to accelerate cures
July 17, 2015
Drug discovery is moving slowly for many diseases because of a “lack of understanding of the
biology of disease,” a top Food and Drug Administration official recently wrote. Robert Califf, a
deputy commissioner at the Food and Drug Administration, calls out the “paucity of reliable
biomarkers in some diseases” in a recent blog post – citing it as a sign that a lot of disease
research isn’t progressing as it should.
Article link:
http://medcitynews.com/2015/07/fda-more-basic-science-research-needed-to-acceleratecures
Psoriasis Drug May Help Preserve Pancreas Cells in Type 1 Diabetes
July 21, 2015
Taking two 12-week courses of alefacept -- a drug already approved to treat the skin condition
psoriasis -- may help people with newly diagnosed type 1 diabetes preserve some function in
the beta cells in the pancreas, a new study suggests.
Article link:
http://consumer.healthday.com/clinical-trials-information-35/clinical-trials-news-136/psoriasisdrug-helps-preserve-pancreas-cells-in-people-with-new-onset-type-1-diabetes-701510.html
FDA Clears 2 New Propeller Health Devices That Track Respiratory Meds
July 22, 2015
Propeller Health has received FDA clearance to sell two new devices to help chronic respiratory
disease patients track their medication usage and better follow their recommended treatment
regimens. Founded in 2010, the Madison, WI-based company makes data-collecting devices
that snap on to medication inhalers used by asthma and chronic obstructive pulmonary disease
(COPD) patients. The devices can note the time and location for each use, information that is
stored and wirelessly transmitted to a user’s smartphone or a Qualcomm base station plugged
into the wall at home. Propeller says its system—which combines sensors, mobile apps,
analytics, and individualized feedback for patients and their caregivers—can help lower
healthcare costs associated with asthma and COPD by helping patients and doctors better
understand the diseases, predict attacks, and reduce hospitalizations.
Article link:
http://www.xconomy.com/wisconsin/2015/07/22/fda-clears-2-new-propeller-health-devicesthat-track-respiratory-meds/
26
High Soda Intake May Boost Diabetes Risk, Even Without Obesity
July 22, 2015
Whether you are slim or obese, if you drink lots of sugary soda or other sweetened drinks you
are more likely to develop type 2 diabetes, a new analysis reveals. Until now, health experts
have thought that sugary drinks and type 2 diabetes were linked because sugar promotes
weight gain, and body fat contributes to insulin resistance, which precedes diabetes.
Article link:
http://www.nlm.nih.gov/medlineplus/news/fullstory_153691.html
Generic Drug Duo More Effective Against Breast Cancer Than Tamoxifen
July 23, 2015
Two inexpensive, generic drugs can reduce breast cancer deaths in postmenopausal women
better than drugs now in wide use, researchers from two related studies concluded. Drugs
called aromatase inhibitors help stop hormones including estrogen from spurring cancer
growth. These drugs are more effective than widely used tamoxifen in reducing breast cancer
death, according to the research.
Article link:
http://www.healthline.com/health-news/generic-drug-duo-more-effective-against-breastcancer-than-tamoxifen-072315
One big myth about medicine: We know how drugs work
July 23, 2015
Here’s how we think we discover powerful new medicines: Scientists dig deep into biology and
zero in on a molecular Achilles’ heel that could disable a devastating disease, be it cancer or an
infection. They concoct experimental drugs that hit the target. Then they conduct trials to find
one that is safe and effective in people.
Article link:
http://www.washingtonpost.com/news/wonkblog/wp/2015/07/23/one-big-myth-aboutmedicine-we-know-how-drugs-work/
Younger Adults With Alzheimer's Are Key To Drug Search
July 23, 2015
The face of Alzheimer's isn't always old. Sometimes it belongs to someone like Giedre
27
Cohen, who is 37, yet struggles to remember her own name. Until about a year ago, Giedre was
a "young, healthy, beautiful" woman just starting her life, says her husband, Tal Cohen, a real
estate developer in Los Angeles. Now, he says, "her mind is slowly wasting away."
Article link:
http://www.npr.org/sections/health-shots/2015/07/23/425320514/younger-adults-withalzheimer-s-are-key-to-drug-search
NSAIDS may increase kidney risks with high blood pressure
July 23, 2015
People with high blood pressure who regularly take common painkillers known as nonsteroidal
anti-inflammatory drugs (NSAIDs) may increase their risk of developing chronic kidney disease,
a study from Taiwan suggests. While some previous research has linked NSAIDs to impaired
kidney function, the results have been mixed and often overlooked the effects on people with
high blood pressure, or hypertension, which itself carries an elevated risk for kidney damage.
Article link:
http://www.reuters.com/article/2015/07/23/us-health-hypertension-nsaids-kidneyidUSKCN0PX2OE20150723
FDA Examines Whether MRI Drugs Accumulate in Brain Tissue
July 27, 2015
The Food and Drug Administration announced today it is investigating the risk of brain deposits
for patients who are given repeated MRIs using imaging drugs that contain a heavy metal.
The FDA did not announce any label changes for the nine medicines that contain the metal,
gadolinium, saying there was a “need for additional information.” However, “to reduce the
potential for gadolinium accumulation,” the safety announcement asked health care
professionals to “consider limiting” their use and to reexamine “the necessity of repetitive”
MRIs involving these drugs.
Article link:
http://www.propublica.org/article/fda-examines-whether-mri-drugs-accumulate-in-braintissue
Serious Risks About Existing Drugs Aren’t Given to Trial Participants
July 29, 2015
There are many reasons drugs already on the market continue to be studied, such as exploring
new uses or conducting follow-up trials required by the FDA. And about 35% of the medicines
28
have boxed warnings on their prescribing labels, which contain the most serious type of risk
information. But new research finds some serious risks are not disclosed on consent forms
given to trial participants.
Article link:
http://blogs.wsj.com/pharmalot/2015/07/29/serious-risks-about-existing-drugs-arent-given-totrial-participants/
AMA, other groups take on patient drug abuse
July 29, 2015
Several of the country's largest physician organizations are collaborating to address the recent
rise in drug overdoses deaths that are due, in part, to the increased use of prescription opioid
painkillers. A total of 27 physician groups led by the American Medical Association are urging
physicians to register in prescription drug monitoring programs as a way to identify patients
who may be at risk of abusing opioid drugs.
Article link:
http://www.modernhealthcare.com/article/20150729/NEWS/150729829/ama-other-groupstake-on-patient-drug-abuse
29
RECALLS*
Product
type
Product description
Code info.
Class
Reason for recall
Recalling firm
Class I
Marketed Without
An Approved
NDA/ANDA: Product
was found to contain
sibutramine,
desmethylsibutramin
e and
phenolphthalein
based on FDA
sampling and
analysis.
Bethel
Nutritional
Consulting, Inc
Class I
Presence of
Particulate Matter:
Baxter
Products recalled due
Healthcare
to presence of
Corp.
particulate matter
(metal)
CLASS I
Drugs
Drugs
SLIM-K, 30 Capsules,
barcode 160126417509
Lot # 140430;
Exp.12/17
0.9% Sodium Chloride
Injection, USP, in 250mL
VIAFLEX Plastic bags
Lot #: C965038,
C965293,
C963785,
C963884,
C963660,
C964320,
C964486 and
C964890, Exp
7/31/2016
Drugs
5% Dextrose Injection,
USP, 250mL VIAFLEX
Plastic bags
Lot #: C963413
and C963413A,
Exp 7/31/2016
Class I
Drugs
10% Dextrose Injection,
USP, 250mL VIAFLEX
Plastic bags
Lot #: C965558
and C963520,
Exp 7/31/2016
Class I
Drugs
Lactated Ringers
Injection, USP, 250mL
VIAFELX Plastic bags
Lot #: C964619,
C964056 and
C964163, Exp
7/31/2016
Drugs
Adrucil (fluorouracil
injection, USP) Pharmacy
Bulk Package Not for
Lot #s:
31317858B, Exp
11/2015;
Class I
Class I
Presence of
Particulate Matter:
to presence of
particulate matter
(metal)
Presence of
Particulate Matter:
to presence of
particulate matter
(metal)
Presence of
Particulate Matter:
to presence of
particulate matter
(metal)
Presence of
Particulate Matter:
Black particulate
Baxter
Healthcare
Corp
Baxter
Healthcare
Corp
Baxter
Healthcare
Corp
Teva
Pharmaceutical
s USA
30
Product
type
Drugs
Product description
Code info.
Direct Infusion, 5 g/100
mL (50 mg/mL), For
Intravenous Use Only, Rx
Only
31317899B,
31317906B,
31317958B,
31317959B,
31318103B,
31318137B, Exp
12/2015;
31318533B, Exp
07/2016
Bupivacaine
Hydrochloride Inj., USP,
0.5% (5 mg/mL),
Preservative-Free, 30 mL
Single Use Vials, Rx only
Lot #: 38-515DK, Expiry: 1
FEB 2016
Class
Reason for recall
Recalling firm
matter was identified
as aggregate of
silicone rubber
pieces from a filler
diaphragm and
fluorouracil crystals.
Class I
Presence of
Particulate Matter:
Presence of freefloating and
embedded iron oxide
particles
Hospira Inc.
CLASS II
Drugs
Rifampin for Injection,
USP 600mg/vial in a 20mL
vial, Rx only
Lot #: 6109469,
6109470, Exp
10/2016
Class II
Drugs
0.9% Sodium Chloride
Injection USP, 50 mL ADDVantage Unit, Rx only
Lot #: 49-084JT; 49-119-JT
Class II
Drugs
Nitroglycerin Transdermal
System 0.2 mg/hr (10
cm2), For Transdermal
Use Only, 30 Systems
(patches) per box, Rx Only
Lot #: 5267605,
Exp 08/2015
Class II
Drugs
Nitroglycerin Transdermal
System 0.4 mg/hr (18
cm2), For Transdermal
Use Only, 30 Systems
(patches) per box, Rx Only
Lot #: 5267504,
Exp 07/2015
Class II
Drugs
KETOROLAC
Tromethamine Inj., USP,
31077DK,
31078DK,
Class II
Failed
impurities/degradati
on specifications;
two lots are out-ofspecification for
impurities and color
Lack of assurance of
sterility: Potential
channel leaks near
the threaded vial
port.
Failed
Impurities/Degradati
on Specifications:
failed specification
for unknown
impurity at the 24
month stability
testing.
Failed
on Specifications:
Two lots failed
specification for
unknown impurity at
the 24 month
stability testing.
Crystallization;
identified as calcium
Fresenius Kabi
USA, LLC
Hospira Inc.
Kremers Urban
Pharmaceutical
s, Inc
Kremers Urban
Pharmaceutical
s, Inc.
Hospira Inc.
31
Product
type
Product description
30 mg (30 mg/mL), 1 mL
Fill, Single-dose Vials
Code info.
31338DK,
31339DK,
31340DK, EXP
01JUL2015;
32068DK,
32069DK, EXP
01AUG2915;
33270DK, EXP
01SEP2015;
34084DK,
34085DK,
34161DK,
34162DK,
34298DK,
34299DK,
34300DK, EXP
01OCT2015;
35011DK,
35081DK,
35082DK,
35116DK, EXP
01NOV2015;
38139DK,
38140DK,
36144DK, EXP
01FEB2016;
39256DK,
39257DK, EXP
01MAR2016;
42210DK,
42227DK,
EXP01JUN2016
; 43017DK,
43116DK,
43117DK,
43292DK,
43293DK, EXP
01JUL2016;
45034DK,
45035DK,
45118DK,
45120DK, EXP
01SEP2016;
46310DK,
46311DK, EXP
01OCT2016
Class
Reason for recall
Recalling firm
salt of Ketorolac
32
Product
type
Product description
Drugs
KETOROLAC
Tromethamine Inj., USP,
60 mg (30 mg/mL), 2 mL
Fill Single-dose Vials,
Drugs
Losartan potassium
tablets USP, 25 mg, 90count bottle, Rx only
Code info.
AND
NOVAPLUS
LOTS 32106DK,
32220DK,
32221DK, EXP
01AUG2015;
33235DK,
33236DK, EXP
01SEP2015;
34163DK,
34164DK, EXP
01OCT2015;
39263DK,
39264DK, EXP
01MAR2016
31075DK,
31076DK,
EXP01JUL2015;
32345DK,
32368DK, EXP
01AUG2015;
33152DK, EXP
01SEP2015;
34538DK, EXP
01OCT2015;
37227DK, EXP
01JAN2016,
41525DK,
42255DK, EXP
01MAY2016;
46042DK,
46045DK,
46048DK,
46304DK,
46305DK,
46432DK,
46433DK, EXP
01OCT2016
AND
NOVAPLUS LOT
31074DK, EXP
01JUL2015
Lot #: KP4726,
Exp date
9/2015
Class
Reason for recall
Recalling firm
Class II
Crystallization;
identified as calcium
salt of Ketorolac
Hospira Inc.
Class II
Failed Content
Uniformity
Specifications: The
Apotex Inc
33
Product
type
Product description
Code info.
Class
Drugs
Losartan potassium
Lot #: KT3819,
Exp 11/2015;
Lot #: KT3821,
Exp 11/2015
Class II
Drugs
Losartan potassium
Lot #: KN1449,
Exp 06/2015
Class II
Drugs
Enalapril maleate and
hydrochlorothiazide
tablets USP, 10/25 mg,
100-count bottle, Rx only
Lot #: KP4529,
Exp 10/2015
Class II
Drugs
Drugs
Drugs
Amlodipine besylate
tablets, USP 2.5mg,
packaged in 10-count
blisters (NDC 68084-49811); 10 blister packs per
carton (NDC 68084-49801); Rx only
Amlodipine besylate
tablets, USP 5mg,
Amlodipine besylate
tablets, USP 10 mg,
carton (NDC 68084-506-
Lot #: 131924,
Exp
07/31/2015
Lot#: 131954,
131955, Exp
08/31/2015
Lot#: 131953,
Exp
07/31/2015
Reason for recall
product may not
meet the limit for
blend uniformity
specification.
Failed Content
Uniformity
Specifications: The
product may not
meet the limit for
blend uniformity
specification.
Failed Content
Uniformity
Specifications: The
product may not
meet the limit for
blend uniformity
specification.
Failed Content
Uniformity
Specifications: The
product may not
meet the limit for
blend uniformity
specification.
Recalling firm
Apotex Inc
Apotex Inc
Apotex Inc
Class II
CGMP Deviations:
Firm did not
adequately
investigate customer
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
34
Product
type
Product description
Code info.
Class
Reason for recall
Recalling firm
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
01); Rx only
Drugs
Drugs
Drugs
Azithromycin tablets, USP
500mg, packaged in 10count blisters (NDC
68084-279-11); 3 blister
packs per carton (NDC
68084-279-21); Rx only
68084-464-11); 3 blister
68084-464-21); Rx only
68084-278-11); 10 blister
68084-278-01); Rx only
Drugs
Clarithromycin tablets,
USP 500mg, packaged in
10-count blisters (NDC
68084-437-11); 5 blister
68084-279-65); Rx only
Drugs
Famotidine tablets, USP
68084-172-11); 10 blister
68084-172-01); Rx only
Lot#: 134419A,
Exp
12/31/2015;
Lot#: 193441B,
Exp
02/29/2016;
Lot#: 133684B,
Exp
09/30/2015.
Lot#: 134420,
142540, Exp
7/31/2015
Lot#: 134392,
Exp
06/30/2015
Lot#: 132323,
Exp
07/31/2015;
Lot#: 132960,
Exp
09/30/2015;
Lot#: 133707A,
Exp
10/31/2015;
Lot#: 133707B,
Exp
11/30/2015.
Lot#: 132146,
Exp
06/30/2015;
Lot#: 132147,
132963, Exp
08/31/2015;
Lot#: 132964,
Exp
10/31/2015;
Lot#: 134319,
Exp
35
Product
type
Product description
Code info.
Class
Reason for recall
Recalling firm
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
CGMP Deviations:
Firm did not
adequately
complaints.
American
Health
Packaging
Class II
Failed Dissolution
Specifications: low
Mylan
Pharmaceutical
12/31/2015;
Lot#: 134320,
Exp
01/31/2016.
Drugs
Drugs
Drugs
Drugs
Lisinopril tablets, USP 5mg
Lisinopril tablets, USP
10mg packaged in 10count blisters (NDC
68084-061-11); 10 blister
68084-061-01); Rx only
68084-062-11); 10 blister
68084-062-01); Rx only
68084-064-11); 10 blister
68084-064-01); Rx only
Drugs
Zonisamide capsules, USP
68084-008-11); 5 blister
68084-008-65); Rx only
Drugs
Capecitabine Tablets, USP,
500 mg, 120-count bottle,
Lot#: 131928,
Exp
09/30/2015
Lot#: 131933,
Exp
07/31/2015
Lot#: 131934,
Exp
09/30/2015
Lot#: 131935,
Exp
08/31/2015
Lot#: 132383:
Exp Date:
07/31/2015;
Lot#: 132989
Exp Date:
10/31/2015;
Lot#: 133694
Exp Date:
03/31/2016l
Lot#: 134418A
Exp Date:
07/31/2016 &
Lot#: 134418B
Exp Date:
07/31/2016.
Lot #: 3053562,
Exp 02/16
36
Product
type
Product description
Code info.
Class
Rx only
Drugs
Drugs
Drugs
Drugs
TPN 3:1, 2400 mL Bag,
Qty: 6, Base Formula
Sodium Chloride, Dextrose
70%, Travasol 10%,
Intralipid 20%, Water for
Inj.; Electrolytes KCL, K
Acetate, Na Acetate, K
Phos, MgSO4; Vitamins,
trace elements and
medications Trace Ele. Ped, Multi Vitamin, Rx
Only
TPN 3:1, 2250 mL Bags,
70%, Clinisol SF 15%,
Inj; Electrolytes KCL, K
Phos, Famotidine, Na
Acetate, MgSO4; Vitamins,
trace elements and
medications Multitrace-4,
Multi Vitamin, Rx Only
Dextrose 70%, Travasol
10%, Intralipid 20%,
Sterile Water; Electrolytes
K Acetate, Na Acetate,
Famotidine, Ca Gluconate,
MgSO4, NaCl, Zinc Cl;
Vitamins, trace elements
and medications
Salenium, Multi Vitamin,
Vitamin K, Ascorbic Acid,
Rx Only
TPN 3:1, 997 ml with lipids
Bags, Qty: 7, Base Formula
10%, Intralipid 20%, Water
All product
compounded
between May
14, 2015 and
May 27, 2015
All product
compounded
between May
14, 2015 and
May 27, 2015
All product
compounded
between May
14, 2015 and
May 27, 2015
All product
compounded
between May
14, 2015 and
Reason for recall
Recalling firm
out-of-specification
(OOS) results for
dissolution were
obtained at the ninemonth stability point.
s Inc
Class II
Lack of Assurance of
Sterility: Sterility of
product is not
assured.
Lincare, Inc
Class II
product is not
assured.
Lincare, Inc
Class II
product is not
assured.
Lincare, Inc
Class II
product is not
assured.
Lincare, Inc
37
Product
type
Drugs
Drugs
Drugs
Drugs
Product description
for Inj; Electrolytes K
Acetate, Na Acetate, KCL,
Na Phos, Ca Gluconate,
MgSO4, NaCl, Zinc Cl;
and medications
Selenium, Copper Cl,
Carnitor, Rx Only
TPN 3:1, 997 ml without
lipids Bags, Qty: 3, Base
Formula Dextrose 70%,
Travasol 10%, Water for
Inj; Electrolytes K Acetate,
Na Acetate, KCL, Na Phos,
Ca Gluconate, MgSO4,
NaCl, Zinc Cl; Vitamins,
trace elements and
medications Selenium,
Copper Cl, Carnitor,
Infuvitm Pediat, Rx Only
TPN 3:1, 1800 ml Bags,
Qty: 2, Base Formula NaCl
0.9%, Dextrose 70%,
Travasol 10%, Intralipid
20%, Water; Electrolytes K
Phos, Mag Sulfate, KCL, Ca
Gluconate; Vitamins, trace
elements and medications
Multitrace-4, Multi
Vitamin, Rx Only
TPN 2:1, 200 ml Bags, Qty:
7, Base Formula NaCl
0.9%, Dextrose 70%,
Trophamine 10%, Water
for Inj; Electrolytes
Calcium Gluc, MgSO4, Na
Phos, KCL; Vitamins, trace
Copper Cl, Selenium, Zinc
Sulfate, Infuvite Pediat, Rx
Only
Code info.
Class
Reason for recall
Recalling firm
Class II
product is not
assured.
Lincare, Inc
Class II
product is not
assured.
Lincare, Inc
Class II
product is not
assured.
Lincare, Inc
Class II
product is not
assured.
May 27, 2015
All product
compounded
between May
14, 2015 and
May 27, 2015
All product
compounded
between May
14, 2015 and
May 27, 2015
All product
compounded
between May
14, 2015 and
May 27, 2015
All product
compounded
between May
14, 2015 and
Lincare, Inc
38
Product
type
Drugs
Drugs
Drugs
Drugs
Product description
Famotidine, MgSO4, KCL,
NaC, Zinc Cl; Vitamins,
trace elements and
medications Multitrace-4,
Multi Vitamin, Vitamin K,
Ascorbic Acid, Rx Only
Calcium Gluc, Na Phos, Na
Acetate, MgSO4, K
Acetate; Vitamins, trace
Multitrace-4, Multi
Vitamin, Folic Acid, Rx
Only
Famotidine, KCL, K Phos,
Na Acetate, MgSO4, NaCl;
and medications
Multitrace-4, Multi
Vitamin, Vitamin K, Rx
Only
Dextrose 70%,
Trophamine 10%,
Inj; Electrolytes K Phos,
KCL, MgSO4, NaCl, Ca
Gluconate; Vitamins, trace
Trace Ele.-Ped, Infuvite
Pediat, Carnitor, Rx Only
Code info.
Class
Reason for recall
Recalling firm
May 27, 2015
Lincare, Inc
All product
compounded
between May
14, 2015 and
May 27, 2015
Class II
product is not
assured.
Lincare, Inc
All product
compounded
between May
14, 2015 and
May 27, 2015
Class II
product is not
assured.
Lincare, Inc
All product
compounded
between May
14, 2015 and
May 27, 2015
Class II
product is not
assured.
All product
compounded
between May
Class II
product is not
Lincare, Inc
39
Product
type
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Product description
KCL, K Phos, MgSO4, NaCl,
Zinc Cl, Ca Gluconate;
and medications Trace
Ele.-Ped, Infuvite Pediat,
Carnitor, Rx Only
for Inj; Electrolytes K Phos,
KCL, MgSO4, NaCl, Ca
Gluconate, Rx Only
70%, Clinisol SF 15%,
Inj; Electrolytes KCL, Ca
Gluconate, MgSO4, K
Phos; Vitamins, trace
Multitrace-4, Multi
Vitamin, Rx Only
Penicillin G Potassium 5.4
MU/SW 240 mL AccuFlo,
Qty: 4 240 mL Bags, Rx
Only
Vancomycin HCl in
Dextrose, VANCOMYCIN
500mg / D5W 100mL
AccuFlo, Qty: 12 100 mL
Bags, Rx Only
Fluorouracil 5760mg /
D5W 265mL Qty: 1 265 mL
Bag, Rx Only
CefTRIAXone Sodium,
Ceftriaxone 1 gram / NS
50 mL, Qty: 10 50 mL
Bags, Rx Only
D5W 278mL Qty: 1 278 mL
Code info.
Class
14, 2015 and
May 27, 2015
Reason for recall
Recalling firm
assured.
Lincare, Inc
All product
compounded
between May
14, 2015 and
May 27, 2015
Class II
product is not
assured.
Lincare, Inc
All product
compounded
between May
14, 2015 and
May 27, 2015
Compounded
on 05/29/15,
Discard After:
06/12/15
Compounded
on 05/29/15,
Discard After:
06/12/15
Compounded
on 05/27/15,
Discard After:
06/10/15
Compounded
on 05/29/15,
Discard After:
06/08/15
Compounded
on 05/29/15,
Class II
product is not
assured.
Class II
product is not
assured.
Class II
product is not
assured.
Class II
Class II
Class II
product is not
assured.
product is not
assured.
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
40
Product
type
Product description
Bag, Rx Only
Drugs
VANCOMYCIN 1.25gm /
NS 250mL AccuFlo, Qty: 7
250 mL Bags, Rx Only
Drugs
Vancomycin HCl in
750mg / D5W 150mL, Qty:
6 150 mL Bags, Rx Only
Drugs
CEFTRIAXONE SODIUM
2000mg / NS 50mL, Qty:4
50 mL Bags, Rx Only
Drugs
D5W 296mL, Qty: 1 296
mL Bag, Rx Only
Drugs
D5W 274mL, Qty: 1 274
mL Bag, Rx Only
Drugs
FLUOROURACIL 1560MG /
D5W 281ML, Qty: 1 281
mL Bag, Rx Only
Drugs
D5W 264mL, Qty: 1 264
mL Bag, Rx Only
Drugs
Drugs
HYDROmorphone HCl PF,
HYDROMORPHONE HCL
1000mg /NS 500mL, Qty:
1 500 mL Bag, Rx Only
Vancomycin HCl in
750mg / D5W 150mL, Qty:
Drugs
D5W 292 mL, Qty: 1 292
mL Bag, Rx Only
Drugs
VANCOMYCIN HCL 250mg
/ NS 6mL syringe,
Packaged in 6 mL Syringes,
Code info.
Discard After:
06/12/15
Compounded
on 05/27/15,
Discard After:
06/10/15
Compounded
on 05/29/15,
Discard After:
06/10/15
Compounded
on 05/27/15;
Discard After:
06/10/15
Compounded
on 05/27/15,
Discard After:
06/10/15
Compounded
on 05/28/15,
Discard After:
06/11/15
Compounded
on 05/26/15,
Discard After:
06/09/15
Compounded
on 05/29/15,
Discard After:
06/12/15
Compounded
on 05/27/15,
Discard After:
06/24/15
Compounded
on 05/29/15,
Discard After:
06/12/15
Compounded
on 05/28/15,
Discard After:
06/11/15
Compounded
on 05/27/2015,
Discard After:
Class
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Reason for recall
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
Recalling firm
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
41
Product
type
Product description
Code info.
Rx Only
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
06/06/2015
Compounded
VANC 50MCG/ML-HEP
on 05/27/2015,
100U/ML in 2ML, Packed
Discard After:
in 2 mL Units, Rx Only
06/11/2015
DEFEROXAMINE
Compounded
MESYLATE 3gm / NS
on 05/28/2015,
240mL Accuflo, Packaged
Discard After:
in 240 mL Bags, Rx Only
06/11/2015
Compounded
CEFEPIME 1gm / NS 50mL
on 05/28/2015,
AccuFlo, Packaged in 50
Discard After:
mL Bags, Rx Only
06/11/2015
CIPROFLOXACIN 400MG / Compounded
D5W 200ML ACCUFLO,
on 05/28/2015,
Packaged in 3 200 mL
Discard After:
Bags, Rx Only
06/11/2015
Vancomycin HCl / Heparin, Compounded
Vancomycin 50mcg/ml /
on 05/27/15,
HEPARIN 100u/ml, Qty: 8, Discard After:
Rx Only
06/10/15
Fentanyl Citrate,
Compounded
FENTANYL 25,000 MCG /
on 05/29/15,
500 ML, Qty: 1 500 mL
Discard After:
Bag, Rx Only
06/26/15
Vancomycin,
Compounded
VANCOMYCIN 750mg / NS on 05/28/15,
100mL AccuFlo, Qty: 7 100 Discard After:
mL Bags, Rx Only
06/11/15
Ceftriaxone Sodium,
Compounded
Ceftriaxone 2gm / NS
on 05/29/15,
50mL, Qty: 12 50 mL Bags, Discard After:
Rx Only
06/12/15
Diphenhydramine HCl,
Compounded
Diphenhydramine 25mg / on 05/27/15,
NS 10 ml syringe, Qty: 2
Discard After:
10 mL syringes, Rx Only
06/10/15
Vancomycin HCl,
Compounded
Vancomycin 1500mg /
on 05/10/15,
D5W 265mL, Qty: 2 265
Discard After:
mL Bags, Rx Only
06/10/15
Vancomycin HCl/Heparin, Compounded
Vancomycin 50mcg/mL /
on 05/27/15,
Heparin 100u/mL, Qty: 3,
Discard After:
Rx Only
06/10/15
Class
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Reason for recall
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
Recalling firm
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
42
Product
type
Product description
Drugs
Cefepime HCl, Cefepime 2
gm / NS 100 mL AccuFlo,
Only
Drugs
Pfizerpen-G 4.2 MU / SW
240 mL AccuFlo, Packaged
in 2 240 mL Bags, Rx Only
Drugs
GENTAMICIN 14.4 mg / NS
30 mL SYRINGE, Packaged
in 30 mL Syringes, Rx Only
Drugs
Vancomycin 750 mg/NS
100 ml accuflo, Packaged
in 100 mL Bags, Rx Only
Drugs
Vancomycin 1000mg / NS
100mL, Packaged in 100
mL Bags, Rx Only
Drugs
Drugs
Drugs
Potassium Chloride,
Dextrose 5% LR 1000 mL
with 40mEq KCL, Qty: 1
1000 mL Bag, Rx Only
Cefepime HCl, CEFEPIME
850 mg NS 50mL AccuFlo,
Only
Morphine Sulfate,
MORPHINE SULFATE
1000mg / NS 100mL, Qty:
1 50 mL Bag, Rx Only
Drugs
Ceftazidime 2 gm / NS
50mL, Qty: 15 50 mL Bags,
Rx Only
Drugs
HYDROmorphone HCl PF,
Hydromorphone 1000 mg
/ NS 500 mL, Qty: 1 500
mL Bag, Rx Only
Drugs
D5W 285mL, Qty: 1 285
mL Bag, Rx Only
Drugs
Ganciclovir Sodium,
Code info.
Compounded
on 05/27/15,
Discard After:
06/10/15
Compounded
on 05/29/2015,
Discard After:
06/12/2015
Compounded
on 05/27/2015,
Discard After:
06/24/2015
Compounded
on 05/29/2015,
Discard After:
06/12/2015
Compounded
on 05/27/2015,
Discard After:
06/10/2015
Compounded
on 05/28/15,
Discard After:
06/11/15
Compounded
on 05/29/15,
Discard After:
06/12/15
Compounded
on 05/30/15,
Discard After:
06/13/15
Compounded
on 05/28/15,
Discard After:
06/11/15
Compounded
on 05/29/15,
Discard After:
06/26/15
Compounded
on 05/29/15,
Discard After:
06/12/15
Compounded
Class
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Class II
Reason for recall
Recalling firm
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
product is not
assured.
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
Lincare, Inc
43
Product
type
Product description
250MG / NS 100ML, QTY:
Code info.
Class
Reason for recall
Drugs
Gentamicin Sulfate,
GENTAMICIN 14.4 mg / NS
30 mL SYRINGE, Qty: 7 30
mL Syringes, Rx Only
on 05/29/15,
Discard After:
06/12/15
Compounded
on 05/27/15,
Discard After:
06/24/15
Drugs
OXYCODONE HCl C-II
Tablets, 5 mg USP, 100count blister cards, Rx
only
Lot # P-20000;
Exp. 08/16 Lot
# P-20004; Exp.
08/16
Drugs
CONTRAVE (naltrexone
HCl and bupropion HCl )
extended-release tablets,
8 mg/ 90 mg, 120-count
bottle, Rx only
Lot # B21642;
Exp. 03/17
Class II
Drugs
Lamivudine and
Zidovudine Tablets USP
150mg/300mg 30 Unit
Dose Blisters, Rx Only
Lot #140849
Class II
Failed dissolution
specifications
American
Health
Packaging
Class II
CGMP Deviations:
Failure of the
manufacturer,
Wockhardt Ltd, to
adequately
complaints.
Allegiant
Health
Class II
Failed Dissolution
Specifications;
exceeded
specification at the 9
hour time point
Dr. Reddy's
Laboratories,
Inc.
Class II
Failed Dissolution
Specifications;
Dr. Reddy's
Laboratories,
Drugs
Famotidine Tablets, USP,
20 mg Tablets, Over the
Counter
Drugs
Divalproex Sodium
Extended-Release Tablets,
USP, (valproic acid
activity), 250 mg, 100
count (NDC 55111-533-01)
and 500 count (NDC
55111-533-05) bottles, Rx
Only
Drugs
Divalproex Sodium
Extended-Release Tablets,
Lot #: 3K34915,
Expiry:
07/2015
100 count
bottle - Lot
#C307859, exp
09/2015; 500
count bottle Lot #C307859
and Lot#
C307812, exp
09/2015
Lot #C308195,
exp 10/2015
Class II
Class II
product is not
assured.
product is not
assured.
Superpotent Drug:
Confirmed customer
complaint of a single
unit dose blister
cavity containing 2
OXYCODONE HCl 5
mg tablets
Failed Tablet/Capsule
Specifications:
Potential tablet
defect of broken
tablets and/or
equatorial splitting of
the bilayer tablets
into the two drug
components
Recalling firm
Lincare, Inc
The Harvard
Drug Group,
LLC
Takeda
Pharmaceutical
s North
America, Inc.
44
Product
type
Product description
Code info.
Class
USP, 500 mg, 100 count
bottles, Rx Only
Drugs
NEXIUM® (esomeprazole
magnesium), DelayedRelease capsules, 20 mg,
30-count bottle, Rx only
Lot # FC0064;
Exp. 05/17
Class II
Reason for recall
Recalling firm
exceeded
specification at the 9
hour time point
Presence of Foreign
Tablets/Capsules:
Confimed customer
compliant by a retail
pharmacist that an
unopened bottle
labeled as NEXIUM®
capsules contained
60 SEROQUEL® XR
tablets
Inc.
AstraZeneca
Pharmaceutical
s LP
CLASS III
Desmopressin Acetate
Tablets, 0.1 mg Tablets,
Rx Only
Lot #:151360,
Expiry:
12/31/2016
Drugs
HydrOXYzine
Hydrochloride Tablets,
USP 25 mg, Rx only
100 count (NDC
0603-3968-21);
LOTS#
T144F13A,
T130G13B,
T132G13A, exp
date 6/15,
T115D14A, exp
date 3/16; 500
count (NDC
0603-3968-28),
LOT# T144F13B
exp date 6/15;
and 1000 count
(NDC 06033968-32); LOTS
# T144F13C,
T132G13B, exp
date 6/15,
T115D14B, exp
date 3/16
Drugs
Magnesium Sulfate
Injection, USP, 50%,
20mL, Single dose Fliptop
Vial, For IV or IM use, Rx
Lot #: 39-569DK, Exp
3/1/2016
Drugs
Class III
Class III
Class III
Tablets/Capsules
Imprinted with
Wrong ID: Some
tablets incorrectly
imprinted with an X
on one side.
Failed Tablet/Capsule
Specifications; The
identification codes
on some tablets may
be unreadable
Failed pH
Specifications:12
month stability
testing
American
Health
Packaging
Qualitest
Pharmaceutical
s
Hospira Inc.
45
Product
type
Drugs
Product description
only
Maximum Strength
Analgesic Thera-Gesic
Pain Relieving Creme
Relief from: Joint and
Muscle Soreness,
Arthritis, Back Aches; 1/8
Oz Sachet, OTC
Code info.
Lot #: 4D040,
Exp 4/2016
Class
Reason for recall
Recalling firm
Class III
Subpotent Drug:
menthol and methyl
salicylate below
specification
BioComp
Pharma, Inc.
Drugs
CORTISOL-MC, 10mg
CAP, packaged in 30 and
90 count bottles, Rx Only
Lot #:
04012015@45,
Expiry:
09/28/2015
Drugs
Disulfiram tablets, USP,
500 mg, 100-count
bottles, Rx only
Lot #:
T142A14A,
T143A14A,
T144A14A, Exp
01/16
Drugs
Dr Blue Pain Relieving
Gel, (4.6% menthol), For
temporary relief of minor
aches and pains of
muscles and joints, a) 2
oz. Tube, NDC 10578035-05, b) 5 oz. Jar, NDC
10578-035-04
Lot # 6086221,
Exp 10/16
Drugs
E-Z-CAT Dry Barium
Sulfate for Suspension
(2% w/w after mixing), 23
g foil pouches, Rx only
Lot #:
00513716,
00514712, Exp
03/2016
Class III
Drugs
Lutera (0.1 mg
levonorgestrel and 0.02
mg ethinyl estradiol
tablets USP), 28 day
Regimen, 6 Tablet
Dispensers per box, 28
Tablets Each, Rx Only
Lot #s: KPPY,
Exp 06/15;
NBXD, NBXF,
Exp 10/16;
NBXG, Exp
09/15; NKZS,
Exp 11/15;
NMPT, NNXB,
NNWG, Exp
Class III
Class III
Class III
Class III
Failed Content
Uniformity
Specifications: Failed
Uniformity of Dosage
Units specifications.
Failed Dissolution
Specifications: During
routine stability
testing at the 12
month time point,
one product lot was
found to be out of
specification for
dissolution.
Superpotent Drug:
Product may not be
uniformly blended
resulting in nonuniform distribution
of the active
ingredient menthol.
Failed stability
specifications: This
recall has been
initiated due to out
of specification
results for viscosity.
Labeling: Incorrect or
Missing Package
Insert; Product is
being recalled
because the birth
control packs were
distributed with outdated package
inserts.
Abrams Royal
Pharmacy II,
LLC
Qualitest
Pharmaceutical
s
Indiana Botanic
Gardens, Inc
Bracco
Diagnostic Inc
Actavis Inc
46
Product
type
Product description
Code info.
Class
Reason for recall
Recalling firm
01/16; NMPV,
NVWN, NVWP,
Exp 02/16;
NMTP, NNXC,
Exp 03/16;
NMWC, NNXH,
Exp 04/16;
PFHT, PFHW,
PFHX, Exp
06/16; PKHH,
PKHN, PKHS,
PKHT, PPGG,
PPGH, PVSZ, Exp
08/16; PYDX,
Exp 09/16.
Drugs
Drugs
Drugs
Drugs
Foradil Aerolizer
(formoterol fumarate
inhalation powder) 12
mcg per capsule, 12
Capsules (Blister strips of
6) per pack. For
inhalation use only, Rx
only
Foradil Aerolizer
(formoterol fumarate
inhalation powder) 12
mcg per capsule, 60
Capsules (Blister strips of
6) per pack. For
inhalation use only, Rx
only
Loratadine Orally
Disintegrating Tablets
USP, 10 mg,
Antihistamine, Allergy
Relief, 24 Hour, 30 Orally
Disintegrating Tablets per
blister pack
Amlodipine besylate and
Atorvastatin calcium
tablets, 5mg/10mg,
packaged in a)30-count
bottle (NDC 43598-32230), b) 90-count bottle
(NDC 43598-322-90), Rx
Lot #: F8011,
Exp May 2015
Lot#: F0082, Exp
May 2015
Lot #: 2625094,
Exp 06/2016
Lot #: a)
C401536, Exp
07/2015; b)
C401538, Exp
07/2015
Class III
Class III
Failed Stability
Specification: out of
specification result
obtained for the
Particle Size
Distribution test
during stability
testing.
Failed Stability
Specification: out of
specification result
obtained for the
Particle Size
Distribution test
during stability
testing.
Novartis
Pharmaceutical
s Corp.
Novartis
Pharmaceutical
s Corp.
Class III
Superpotent Drug:
Out Of Specification
(OOS) result for
Assay.
Ohm
Laboratories,
Inc.
Class III
Subpotent drug
Dr. Reddy's
Laboratories,
Inc
47
Product
type
Drugs
Drugs
Drugs
Drugs
Product description
Only
tablets, 10mg/10mg,
(NDC 43598-321-90), Rx
Only
tablets, 10mg/40mg, 90count bottle, Rx Only
tablets, 5mg/40mg
(NDC 43598-316-90), Rx
Only
Fentanyl Citrate Inj., USP,
CII, 250 mcg/5 mL (50
mcg/mL) (0.05 mg/mL),
Rx Only
Code info.
Lot #: a)
C401537, Exp
07/2015; b)
C401539, Exp
07/2015
Class
Class III
Reason for recall
Recalling firm
Subpotent drug
Dr. Reddy's
Laboratories,
Inc
Lot # C309280
Class III
Subpotent drug
Dr. Reddy's
Laboratories,
Inc
Lot # C402439
Class III
Subpotent drug
Dr. Reddy's
Laboratories,
Inc
Class III
Failed
on Specifications; 12
month stability
testing (Expansion of
RES #70548).
West-Ward
Pharmaceutical
Corp.
Lot #: 043410,
Exp 04/2015;
053391, Exp
05/2015;
073340, Exp
07/2015;
083330,
083333,
083335, Exp
08/2015;
093319,
093321,
093323, Exp
09/2015;
103316,
103318, Exp
10/2015
Vaccines
Biologics
None
*Please refer to FDA website for further information; http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
48
CURRENT DRUG SHORTAGES‡
Acetazolamide Injection
June 25, 2015
Reason for the Shortage
 West-Ward is not actively marketing acetazolamide injection at this time.
 A Sagent has acetazolamide injection on shortage due to manufacturing delay.
Article Link:
http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=463
Source Link: http://www.ashp.org
Boceprevir Capsules
June 25, 2015
 Merck Sharp & Dohme has made a business decision to discontinue Victrelis capsules in
the US by December 2015.
 Merck Sharp & Dohme is the sole supplier of boceprevir capsules.
Article Link:
Cefotetan Disodium Injection
June 25, 2015
 BBraun could not provide a reason for the shortage.
 Fresenius Kabi states the reason for the shortage is manufacturing delay
Article Link:
49
L-Cysteine Hydrochloride Injection Ondansetron Injection
June 25, 2015
 American Regent has L-cysteine hydrochloride injection on back order due to
manufacturing delays.
 Sandoz has L-cysteine in short supply due to requirements related to complying with
good manufacturing practices.
Article Link:
Ondansetron Injection
June 26, 2015
 AuroMedics did not provide a reason for the shortage.
 Fresenius Kabi has ondansetron injection on back order due to increased demand.
 Heritage cannot provide a reason for the shortage.
 Sagent has ondansetron on back order due to increased demand.
 The Medicines Company will no longer be supplying ondansetron.
 West-Ward had ondansetron on back order due to increased demand.
 Wockhardt has ondansetron injection on an FDA import alert.
Article Link:
Cefpodoxime
June 29, 2015
 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.
50
Article Link:
Fomepizole Injection
June 29, 2015
 Sandoz could not provide a reason for the shortage. However, fomepizole injection is
manufactured by Emcure for Sandoz. An Emcure manufacturing site was recently noted
to have FDA observations related to GMP and aseptic practices.
 X-Gen could not provide a reason for the shortage.
 Mylan Institutional could not provide a reason for the shortage.
Article Link:
Heparin Premixed Bags
June 29, 2015
 Baxter and BBraun had product on allocation due to increased demand.
 Hospira states the reason for the shortage is manufacturing delays.
Article Link:
Phytonadione (Vitamin K) Injection
June 29, 2015
 Amphastar has vitamin K injection on shortage due to increased demand for the
product.
 Oral vitamin K is not affected by this shortage.
51
Article Link:
Indigo Carmine Injection
June 30, 2015
 American Regent has indigo carmine on back order due to manufacturing delays.
 Akorn has discontinued production of indigo carmine due to shortage of raw material.
Article Link:
Phenazopyridine Hydrochloride Atorvastatin Tablets
June 30, 2015
 Amneal Pharmaceuticals, Avkare, SDA Laboratories discontinued phenazopyridine
tablets.
 Marlex could not provide a reason for the shortage.
Article Link:
Atorvastatin Tablets
July 1, 2015
 Ranbaxy discontinued atorvastatin in late-2014.
 Apotex has atorvastatin tablets on allocation due to increased demand.
 Greenstone and Sandoz state the shortage is due to demand exceeding supply.
Article Link:
52
Cefuroxime Sodium Injection Chlorpromazine Injection
July 1, 2015
 Sagent suspended the manufacture of cefuroxime injection.
 BBraun, Fresenius Kabi, and Hospira discontinued manufacturing cefuroxime in 2013.
Article Link:
Chlorpromazine Injection
July 1, 2015
 West-Ward has chlorpromazine injection on shortage due to manufacturing delays.
Article Link:
Dexrazoxane Injection
July 1, 2015
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
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.
 Mylan Institutional cannot provide a reason for the shortage.
Article Link:
53
Doxorubicin Liposomal Injection
July 1, 2015
 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.
 FDA approved a new manufacturer of Doxil in January 2015.
 Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.
 Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can
supply the market with their presentations.
Article Link:
Methotrexate Injection
July 1, 2015
 Sandoz discontinued methotrexate 2 mL and 10 mL vials.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including methotrexate injection.
West-Ward is not actively marketing methotrexate injection.
 Teva has methotrexate on short-term back order for standard quality control.
Article Link:
Sodium Bicarbonate Injection
July 1, 2015
 Hospira has sodium bicarbonate on shortage due to increased demand.
 Hospira is the sole supplier of the 4.2% 10 mL syringes used in pediatric patients.
 Amphastar has sodium bicarbonate on shortage due to increased demand and has a
new NDC number for the product.
54
Article Link:
Ciprofloxacin Immediate-Release Tablets
July 2, 2015
 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:
Dextran Low Molecular Weight (Dextran 40), 10% Injection
July 2, 2015
 Hospira states the reason for the shortage is manufacturing delay and increased
demand.
Article Link:
Pramipexole Dihydrochloride Tablets
July 2, 2015
 Aurobindo, Mylan, and Sandoz cannot provide a reason for the shortage.
55
Article Link:
Sodium Phosphate Injection
July 2, 2015
 American Regent has sodium phosphate injection on back order due to manufacturing
delays.
 American Regent has issued a statement that all lots of sodium phosphate have
potential for crystallization. Do not use if any particles are present.
 Hospira had sodium phosphate injection on shortage due to manufacturing delays.
 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.
 Fresenius Kabi launched sodium phosphate injection in mid-January 2014.
Article Link:
Digoxin Injection
July 5, 2015
 West-Ward states the shortage is due to manufacturing delays..
Article Link:
Metoprolol Injection
July 5, 2015
56









American Regent has metoprolol injection on shortage due to manufacturing delays.
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
Claris has metoprolol injection available.
Fresenius Kabi states the shortage is due to increased demand for the product.
Hospira states the shortage is due to increased demand for the product.
Novartis discontinued Lopressor injection in mid-2015.
Sagent states the shortage is due to increased demand for the product.
Sandoz cannot provide a reason for the shortage.
West-Ward had metoprolol injection available.
Article Link:
Ammonium Chloride Injection
July 7, 2015
 Hospira states the shortage of ammonium chloride is due to manufacturing delays.
 Hospira is the sole manufacturer of ammonium chloride injection.
Article Link:
Electrolyte Concentrate
July 7, 2015
 American Regent has Nutrilyte and Nutrilyte on back order due to manufacturing delays.
Article Link:
57
Lactated Ringer’s Injection Bags
July 7, 2015
 Baxter has lactated ringers on shortage due to increased demand.
 BBraun has lactated ringers on allocation due to increased demand.
 Hospira cited increased demand as the reason for the shortage.
Article Link:
Nebivolol Tablets
July 7, 2015
 Actavis could not provide a reason for the shortage.
Article Link:
Sodium Chloride 0.9% Irrigation
July 7, 2015
 Baxter has 0.9% sodium chloride irrigation on shortage due manufacturing delays.
 BBraun has 0.9% sodium chloride irrigation on shortage due to increased demand and
only has product available for existing customers.
 Hospira has 0.9% sodium chloride irrigation on shortage due manufacturing delays and
only has product available for existing customers.
Article Link:
58
Sodium Chloride 0.9% Injection Bags
July 7, 2015
 Baxter has 0.9% sodium chloride on shortage due to increased demand.
 BBraun had 0.9% sodium chloride on allocation due to increased demand.
 Hospira cites increased demand as the reason for the shortage.
 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.
 In cooperation with the FDA, Baxter is providing 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 an FDA-approved facility in Spain by Baxter.
Article Link:
Vecuronium Bromide Injection
July 7, 2015
 Hospira states the shortage is due to manufacturing delays.
 Teva states the shortage is due to manufacturing delays.
 Pfizer sold vecuronium injection to Mylan Institutional in December 2013.
 Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.
 Caraco has vecuronium injection available. NDCs changed in mid-2015.
 Sagent temporarily suspended the manufacture of vecuronium 10 mg and 20 mg vials.
Article Link:
59
Caffeine and Sodium Benzoate Injection
July 8, 2015
 American Regent had caffeine and sodium benzoate injection on shortage due to
 American Regent is the sole manufacturer of caffeine and sodium benzoate injection.
Article Link:
Carboplatin Solution for Injection
July 8, 2015
 Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of
other products.
 Fresenius Kabi has carboplatin on shortage due to increased demand for the product.
 Hospira has carboplatin injection available.
 Sagent has carboplatin injection available.
 Sandoz has discontinued carboplatin injection.
 Teva had carboplatin injection on short-term back order due to standard quality
inspections.
Article Link:
Doxorubicin Injection
July 8, 2015
 West-Ward Pharmacetuicals’ parent company, Hikma Pharmaceuticals, acquired
Adriamycin injection from Bedford in July 2014. West-Ward is not actively marketing
Adriamycin injection at this time.
 Teva has doxorubicin solution for injection available.
 Fresenius Kabi has doxorubicin solution for injection available.
60




Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.
Pfizer had doxorubicin solution for injection on shortage due to shipping delays.
Sagent has doxorubicin solution for injection on shortage due to increased demand.
Mylan cannot provide a reason for the reason for the doxorubicin solution for injection
available.
Article Link:
Lactated Ringer's Irrigation
July 8, 2015
 Baxter has lactated ringer’s on shortage due manufacturing delays.
 BBraun has lactated ringer’s irrigation on shortage due to increased demand.
 Hospira has lactated ringer’s irrigation on shortage due to increased demand.
Article Link:
Mesna Injection
July 8, 2015
 Fresenius Kabi had mesna on shortage due to increased demand.
 Mylan could not give a reason for the shortage of mesna.
 Sagent has mesna on shortage due to manufacturing delays.
 Teva had a shortage of mesna injection due to manufacturing delays.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired mesna
injection from Bedford in July 2014. West-Ward is not actively marketing mesna
injection at this time.
Article Link:
61
Milrinone Injection
July 8, 2015
 Fresenius Kabi states the reason for the shortage is increased demand for the product.
 Hospira has milrinone injection on shortage due to increased demand.
 West-Ward states the shortage is due to manufacturing delays.
Article Link:
Pantoprazole Injection
July 8, 2015
 Pfizer has Protonix on shortage due to increased demand.
 Pfizer is the sole supplier of pantoprazole injection.
Article Link:
Promethazine Injection
July 8, 2015
 West-Ward states the shortage was due to manufacturing delays.
Article Link:
62
Acamprosate Calcium Tablets
July 9, 2015
 Glenmark Pharmaceuticals could not provide a reason for the shortage.
 Mylan cannot provide a reason for the shortage.
 Actavis discontinued Campral tablets in 2014.
Article Link:
Adenosine Injection
July 9, 2015
 Astellas discontinued Adenoscan in April 2015. 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.
 Sagent has adenosine vials on shortage due to increased demand.
 West-Ward could not provide a reason for the shortage.
Article Link:
Amoxicillin 875 mg Tablets
July 9, 2015
 Aurobindo had amoxicillin on shortage due to manufacturing delays.
 Citron Pharma supplies product to current customers.
 Dr Reddy’s discontinued amoxicillin 875 mg tablets in June 2014.
 Ranbaxy has an FDA import ban on amoxicillin tablets.
 Sandoz cannot provide a reason for the shortage.
 West-Ward has amoxicillin on shortage due to increased demand.
Article Link:
63
Azathioprine Tablets
July 9, 2015
 Roxane discontinued azathioprine tablets in mid-January 2015 due to problems
obtaining active ingredient.
 Valeant acquired Salix Pharmaceuticals in April 2015.
 Mylan could not provide a reason for the shortage.
 Prometheus Laboratories states the reason for the shortage was increased demand.
Article Link:
Carbidopa and Levodopa Extended-Release Tablets
July 9, 2015
 Caraco could not provide a reason for the shortage.
 Merck could not provide a reason for the shortage.
Article Link:
Dexamethasone Sodium Phosphate
July 9, 2015
 American Regent has dexamethasone sodium phosphate on shortage due to
 Fresenius Kabi states the dexamethasone sodium phosphate shortage is due to supply
and demand issues.
64


West-Ward had dexamethasone sodium phosphate injection on shortage due to
increased demand.
Mylan Institutional states the shortage is due to increased demand.
Article Link:
Ketorolac Tromethamine Injection
July 9, 2015
 Fresenius Kabi has ketorolac injection available.
 Hospira has ketorolac on shortage due to manufacturing delays for quality improvement
activities and increased demand for the product.
 Hospira issued a voluntary recall of several presentations of ketorolac in January 2015
due to potential for particulate matter.
 Sagent states the reason for the shortage is demand exceeding supply.
 West-Ward has ketorolac injection on shortage due to manufacturing delays.
 Ben Venue closed its plant in Bedford, Ohio in July 2014.
 FDA imposed an import ban in mid-2013 on several Wockhardt products including
ketorolac.
 Sprix Nasal Spray is not affected by this shortage.
Article Link:
Leuprolide Acetate 14-Day Kit
July 9, 2015
 Caraco has a new NDC number for the leuprolide injection.
Article Link:
65
Methylphenidate Hydrochloride Chewable Tablets
July 9, 2015
 Shionogi Pharma has Methylin chewable tablets on shortage due to manufacturing
issues.
 Gavis launched methylphenidate chewable tablets in April 2015.
Article Link:
Nimodipine Oral Solution
July 9, 2015
 Arbor has Nymalize oral solution on temporary back order due to shortage of an active
ingredient.
 Nimodipine oral capsules are not affected by this shortage.
Article Link:
Sufentanil Injection
July 9, 2015
 West-Ward had sufentanil on shortage due to manufacturing delays.
 Hospira has sufentanil on shortage due to manufacturing delays.
 Akorn could not provide a reason for the shortage.
Article Link:
66
Testosterone Cypionate Intramuscular Injection
July 9, 2015
 Actavis discontinued testosterone cypionate injection in 2015.
 Paddock has testosterone on shortage 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.
 Sun Pharmaceuticals could not provide a reason for the shortage.
Article Link:
Vancomycin Hydrochloride Injection
July 9, 2015
 Hospira has vancomycin on shortage due to increased demand.
 Fresenius Kabi has vancomycin injection on shortage due to increased demand.
 Baxter is allocating vancomycin.
 Sagent has vancomycin injection on allocation due to increased demand.
Article Link:
Atropine Sulfate Injection
July 10, 2015
 American Regent states the shortage was due to manufacturing delays.
 Amphastar has atropine on shortage due to increased demand.
Article Link:
67
Furosemide Injection
July 10, 2015
 Fresenius Kabi has furosemide injection on shortage due to increased demand for the
product.
 American Regent has furosemide injection on shortage due to manufacturing delays.
 Hospira has furosemide injection available.
 Wockhardt has discontinued all furosemide injection presentations.
 Claris could not provide a reason for the shortage.
Article Link:
Imipenem Cilastatin Injection
July 10, 2015
 Fresenius has imipenem-cilastatin injection on shortage due to short expiration dating.
 Hospira has imipenem-cilastatin injection on shortage due to manufacturing delays.
 Merck cannot provide a reason for the shortage of Primaxin injection.
Article Link:
Lidocaine Injection
July 10, 2015
 Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand
for the product.
 AuroMedics introduced lidocaine injection in February 2014.
 Fresenius Kabi has Xylocaine and lidocaine presentations on shortage due to increased
demand for the product.
68

Hospira has lidocaine presentations on shortage due to manufacturing delays and
increased demand.
Article Link:
Meningococcal Vaccines
July 10, 2015
 Sanofi Pasteur cannot provide a reason for the shortage.
 GlaxoSmithKline acquired Bexsero and Menveo from Novartis Vaccines and Diagnostics
in 2015. The company could not provide a reason for the shortage of Bexaro.
 Pfizer has Trumenba available.
Article Link:
Methylene Blue Injection
July 10, 2015
 Akorn has methylene blue on back order due to manufacturing delays.
 American Regent has methylene blue on back order due to manufacturing delays.
Article Link:
Ofloxacin Otic Solution
July 10, 2015
 Apotex discontinued ofloxacin otic solution in early 2015.
69

Valeant cannot provide a reason for the shortage.
Article Link:
Valproate Sodium Injection
July 10, 2015
 Fresenius Kabi states the reason for the shortage was manufacturing delay.
 West-Ward could not provide a reason for the shortage.
Article Link:
Amikacin Injection
July 13, 2015
amikacin injection from Bedford in July 2014. West-Ward is not actively marketing
amikacin 250 mg/mL 4 mL vials at this time.
 Teva’s product was unavailable due to manufacturing delays.
 Heritage has amikacin injection on shortage due to manufacturing delays.
Article Link:
Chorionic Gonadotropin (Human) Injection
July 13, 2015
 Merck states their product is on allocation to prevent use in the gray market.
70
Article Link:
Desmopressin Injection
July 13, 2015
 Teva and Hospira have desmopressin injection on shortage due to manufacturing
delays.
 Ferring acquired marketing rights of DDAVP from Sanofi in October 2014.
Article Link:
Dextrose (50%) Injection
July 13, 2015
 Amphastar has 50% dextrose injection on shortage due to increased demand.
 Hospira has 50% dextrose injection on shortage due to increased demand.
Article Link:
Ethiodized Oil
July 13, 2015
 Guerbet states their Lipiodol product is in short supply due to manufacturing problems
at Jubliant HollisterStier, the manufacturing site in Canada that supplies Lipiodol for
Guerbet. The company estimates the shortage will last at least one year.
Article Link:
71
Propranolol Hydrochloride Tablets
July 13, 2015
 Actavis cannot provide a reason for the shortage.
 Heritage states the reason for the shortage is a raw materials issue.
 Northstar discontinued all propranolol tablets in February 2015.
 Qualitest refuses to provide product availability as the company considers it proprietary
information.
 Teva could not provide a reason for the shortage.
Article Link:
Tacrolimus Capsules
July 13, 2015
 Novartis discontinued all Hecoria presentations in February 2015.
 Mylan discontinued the 500 count presentations in early 2015.
 Sandoz states the reason for the shortage was manufacturing delay.
Article Link:
14.6% Sodium Chloride Concentrated Solution for Injection
July 14, 2015
 Hospira has 14.6% sodium chloride solutions for injection on shortage due to
72
Article Link:
23.4% Sodium Chloride Concentrated Solution for Injection
July 14, 2015
 Fresenius Kabi has sodium chloride concentrated solution on shortage due to increased
demand.
 Hospira has 23.4% sodium chloride solutions for injection on shortage due to increased
demand.
Article Link:
Atenolol Tablets
July 14, 2015
 AstraZeneca divested Tenormin to Almatica in January 2015.
 Almatica has new NDC numbers for Tenormin tablets.
 Pack Pharmaceuticals discontinued atenolol tablets in October 2014.
 Ranbaxy has atenolol tablets on shortage due to manufacturing delays.
 Zydus has atenolol tablets on allocation due to increased demand.
 Aurobindo and Caraco have discontinued atenolol tablets.
Article Link:
Buprenorphine Sublingual Tablets
July 14, 2015
 Teva could not provide a reason for the shortage.
73

Akorn acquired Hi-Tech Pharmacal in 2014.
Article Link:
Etomidate Injection
July 14, 2015
 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 increased demand.
 Par Sterile Products discontinued etomidate in early 2015.
Article Link:
Mercaptopurine Tablets
July 14, 2015
 Par discontinued mercaptopurine tablets in October 2014.
 Teva discontinued mercaptopurine generic and Purinethol in mid-2015.
Article Link:
Midazolam Injections
July 14, 2015
 West-Ward acquired Baxter’s midazolam injection products in May, 2011.
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in 2014.
74









Hospira has midazolam on shortage due to manufacturing delays and demand
exceeding supply due to current market conditions.
Fresenius Kabi had midazolam on shortage due to increased demand.
Due to low demand, Akorn is focusing on other medications that are in greater need of
supply.
Sagent has midazolam on shortage due to manufacturing delay.
Caraco has discontinued all midazolam presentations.
Caraco discontinued two midazolam presentations in 2014.
FDA imposed an import ban in mid-2013 on several Wockhardt products including
midazolam injection.
Medicines Company is no longer carrying midazolam injection.
BD RX introduced midazolam injection in 2014.
Article Link:
Morphine Injections
July 14, 2015
 Fresenius Kabi states the shortage is due to a change in manufacturing sites and cannot
estimate when Astramorph will return.
 West-Ward states the shortage was due to increased demand for product.
Article Link:
Piperacillin Tazobactam Injection
July 14, 2015
 Apotex has piperacillin/tazobactam on shortage due to regulatory delays.
 AuroMedics and Sandoz could not provide a reason for the shortage.
 Baxter has Zosyn frozen premixes on allocation due to increased demand.
 Fresenius Kabi has piperacillin/tazobactam on shortage due to increased demand.
 Hospira has piperacillin/tazobactam on shortage due to manufacturing delays.
75



Sagent has piperacillin/tazobactam on shortage due to increased demand.
Pfizer has Zosyn on shortage due to manufacturing delays. Pfizer estimates there will be
supply shortages through September 2015 for the single dose vials and 1st quarter 2017
for the bulk vials.
WG Critical Care states the reason for the shortage is increased demand.
Article Link:
Ranitidine Injection
July 14, 2015
ranitidine injection from Bedford in July 2014. West-Ward discontinued ranitidine
injection in September 2014.
 Covis has Zantac on shortage due to capacity issues at the manufacturer.
 Oral ranitidine products are not affected by this shortage.
Article Link:
Sterile Water Irrigation
July 14, 2015
 Baxter had sterile water for irrigation on shortage due manufacturing delays.
 BBraun only has product available for existing customers.
 Hospira only has product available for existing customers.
Article Link:
76
Sumatriptan Succinate Injection
July 14, 2015
 Sagent states the reason for the shortage is increased demand.
 GlaxoSmithKline has product available with short expiration dating.
 Pfizer has had Alsuma on shortage since September 2013 due to manufacturing issues.
 Zogenix sold Sumavel DosePro to Endo in 2014.
 Teva has temporarily suspended the production of sumatriptan injection.
Article Link:
Thiotepa for Injection
July 14, 2015
products from Bedford Laboratories in July 2014 including thiotepa injection. WestWard discontinued thiotepa injection in September 2014.
 FDA is allowing temporary importation of Tepadina (thiotepa), from Adienne SA in Italy.
Product may be ordered directly through Adienne SA. The solution is similar in
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.
Article Link:
77
Amino Acid Products
July 15, 2015
 Baxter has all amino acid products available to current customers.
 BBraun has Plenamine and TrophAmine on allocation due to increased demand.
 Hospira has amino acid products on back order due to manufacturing delays.
Article Link:
Calcium Chloride Injection
July 15, 2015
 American Regent has calcium chloride on shortage due to manufacturing delays.
 Amphastar had calcium chloride on shortage due to increased demand.
 Hospira has calcium chloride on shortage due to increased demand.
 Mylan Institutional has withdrawn calcium chloride syringes from the market. The
company recalled the syringes in April 2015 due to incompatibility of the syringes and
some needless adaptors.
Article Link:
Acetylcysteine Inhalation Solution
July 16, 2015
 American Regent has acetylcysteine oral and inhalation solution on shortage due to
 Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
 Hospira has consistent supply of acetylcysteine oral and inhalation solution.
 Fresenius Kabi states the reason for the shortage was increased demand.
Article Link:
78
Ceftriaxone Sodium Injection
July 16, 2015
 Fresenius Kabi states the reason for the shortage is increased demand.
 Hospira has a consistent supply of ceftriaxone injection.
 WG Critical Care states the reason for the shortage is increased demand.
Article Link:
Ephedrine Injection
July 16, 2015
 Hospira discontinued ephedrine in March, 2011.
 Sandoz discontinued ephedrine in summer 2015.
Article Link:
Lorazepam injectable presentations
July 16, 2015
 Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of
other products.
 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 had Ativan on back order due to increase surplus of the lorazepam
presentations.
 Hospira has consistent supply of lorazepam injection.
79


Akorn increased production to help meet demand.
Amphastar had lorazepam 2 mg/mL vials on shortage due to increased demand.
Article Link:
Magnesium Sulfate Injection
July 16, 2015
 American Regent has magnesium sulfate on shortage due to manufacturing delays.
 Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand
for the product.
 Hospira has consistent supply of magnesium sulfate injection.
 X-Gen has magnesium sulfate injection on shortage due to increased demand.
Article Link:
Potassium Chloride Injection
July 16, 2015
 Baxter has a consistent supply of potassium chloride injection.
 Hospira has a consistent supply of potassium chloride injection.
 Fresenius Kabi could not provide a reason for the shortage.
Article Link:
80
Rocuronium Injection
July 16, 2015
 Merck discontinued Zemuron 10 mL multidose vials in the 3rd Quarter of 2013. Merck
discontinued Zemuron 5 mL vials in June 2014.
 Mylan Institutional states the reason for the shortage was increased demand.
 Hospira has a consistent supply of rocuronium injection.
 Teva has rocuronium on shortage due to manufacturing delays.
 Fresenius Kabi has rocuronium injection available.
 Sagent cites increased demand as the reason for this shortage.
 Sandoz has rocuronium injection available.
 The Medicines Company is no longer supplying rocuronium injection.
 X-Gen has rocuronium injection available.
Article Link:
Succinylcholine chloride Injection
July 16, 2015
 Hospira has a consistent supply of Quelicin injection.
 Sandoz has Anectine on shortage due to extra quality reviews.
Article Link:
Verapamil Injection
July 16, 2015
 Hospira has verapamil injection on shortage due to increased demand for the product.
 Hospira is the sole supplier of verapamil injection.
Article Link:
81
Aripiprazole Oral Disintegrating Tablets
July 17, 2015
 Otsuka has discontinued Abilify Discmelt oral disintegrating tablets. The company has
also discontinued the oral solution and injection.
 There are no other suppliers of aripiprazole oral disintegrating tablets.
 Abilify oral tablets and generic aripiprazole oral tablets are not affected.
Article Link:
Atracurium Injection
July 17, 2015
 West-Ward discontinued atracurium in September 2014.
 Hospira has atracurium available.
 Sagent has atracurium on shortage due to product recall.
Article Link:
Benzonatate Capsules
July 17, 2015
 Amneal and Ascend Laboratories cannot provide a reason for the shortage.
 Caraco discontinued benzonatate capsules in mid-2015.
 Zydus states the reason for the shortage is manufacturing delay.
 Pfizer had Tessalon Perles on shortage due to supply and demand issues.
Article Link:
82
Bupivacaine Injection
July 17, 2015
 Fresenius Kabi has Sensorcaine on shortage due to increased demand for the product.
 Hospira has bupivacaine on shortage due to manufacturing delays.
 AuroMedics introduced bupivacaine injection in February 2014.
Article Link:
Cisplatin Injection
July 28, 2015
Article Link:
Disopyramide Phosphate Controlled-release Capsules
July 17, 2015
 Pfizer has Norpace CR on shortage due to manufacturing delays.
Article Link:
Ethambutol Tablets
July 17, 2015
 Akorn acquired VersaPharm, Inc. in 2014.
83
 Akorn could not provide a reason for the shortage.
 X-Gen could not provide a reason for the shortage.
 G&W Laboratories discontinued ethambutol tablets in mid-April 2013.
Article Link:
Labetalol Injection
July 17, 2015
 Hospira has labetalol on shortage due to increased demand.
 Sagent suspended production on labetalol 5 mg/mL 20 mL vials (NDC 25021-0300-20) in
July 2013 and 40 mL vials in February 2014 (NDC 25021-0300-40) and the company has
no estimated release date for further production.
products from Bedford Laboratories in July 2014 including labetalol injection. WestWard is not actively marketing labetalol injection.
Article Link:
Lidocaine with Epinephrine Injection
July 17, 2015
 Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to
increased demand for the product.
 Hospira had lidocaine with epinephrine presentations on shortage due to manufacturing
delays and increased demand.
Article Link:
84
Acetaminophen and Codeine Phosphate 300 mg/30 mg Tablets
July 20, 2015
 Mallinckrodt states the shortage is due a variety of market conditions.
 Aurobindo and Mylan cannot provide a reason for the shortage.
 Janssen cannot provide a reason for the shortage.
 Qualitest will not provide shortage information for any of their products because they
consider the information to be proprietary.
Article Link:
Ampicillin Sulbactam
July 20, 2015
 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.
 WG Critical Care states the shortage is due to increased demand.
 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:
Aprepitant Capsules
July 20, 2015
 Merck is the sole supplier of Emend (aprepitant) capsules.
 Merck states the reason for this shortage is increased demand.
85

Emend injection is not affected by this shortage.
Article Link:
Atropine Sulfate Ophthalmic Solution
July 20, 2015
 Alcon has Isopto Atropine only available through wholesalers and not available for direct
order.
 Akorn received FDA approval for atropine sulfate 1% ophthalmic solution in July 2014;
this new product launched in January 2015. All other atropine sulfate ophthalmic
solution products are unapproved products.
 Sandoz could not provide a reason for the shortage.
 Valeant discontinued their atropine sulfate 1% ophthalmic solution products in 2015.
Article Link:
 Alcon has Isopto Atropine only available through wholesalers and not available for direct
order.
Cardioplegic Solution for Cardiac Perfusion
July 20, 2015
 Baxter states the reason for the shortage is increased demand.
 Hospira states the reason for the shortage is manufacturing delay.
Article Link:
86
Deferoxamine Mesylate Injection
July 20, 2015
 Fresenius Kabi states the shortage was due to increased demand.
 Hospira has deferoxamine in short supply due to shortage of an active ingredient and
increased demand.
 Teva discontinued all deferoxamine presentations in 2013.
 West-Ward discontinued deferoxamine in September 2014.
 Watson discontinued all deferoxamine presentations.
Article Link:
Hydroxyamphetamine Hydrobromide and Tropicamide Ophthalmic Solution
July 20, 2015
 Akorn discontinued Paredrine ophthalmic solution in 1999.
 Letco Medical discontinued hydroxyamphetamine powder in 2007.
 Spectrum discontinued hydroxyamphetamine powder in 2010.
 Professional Compounding Centers of America (PCCA) had previously supplied
hydroxyamphetamine powder (NDC 51927-2239-00) to pharmacies who were members
of the organization. PCCA does not provide any information regarding product
availability to non-members.
Article Link:
Leflunomide Tablets
July 20, 2015
 Apotex has temporarily discontinued leflunomide and cannot state if they will bring the
product back to market.
 Heritage states the shortage is due to a delay in obtaining active ingredient.
 Sanofi-Aventis could not provide a reason for the shortage.
87
Article Link:
Sterile Water for Injection Large Volume Bags
July 20, 2015
 Baxter had sterile water for injection on shortage due manufacturing delays.
 BBraun has sterile water for injection on shortage due to increased demand and only
has product available for existing customers.
 Hospira has sterile water for injection available for existing customers.
Article Link:
Tamsulosin Hydrochloride Capsules
July 20, 2015
 Boehringer Ingelheim could not provide a reason for the shortage.
 Actavis and Zydus state the reason for the shortage is increased demand.
 Aurobindo is not marketing the 100 count size.
 Caraco cannot provide a reason for the shortage.
 Teva discontinued tamsulosin 0.4 mg capsules in April 2014.
 Par discontinued tamsulosin 0.4 mg capsules.
 Sandoz has tamsulosin on shortage due to increased demand for the product.
Article Link:
88
Ceftazidime Injection
July 21, 2015
 Covis had Fortaz premixed bags on shortage due to increased demand.
 Hospira has Tazicef on shortage due to increased demand.
 Sagent has ceftazidime injection on shortage due to manufacturing delays
Article Link:
Clindamycin Injection
July 21, 2015
 Pfizer states the Cleocin Add-Vantage vials are on shortage due to manufacturing delays.
 Hospira had clindamycin injection on shortage due to manufacturing delays.
 Sandoz had clindamycin injection on shortage due to increased demand.
 Sagent has clindamycin injection on shortage due to manufacturing delays.
Article Link:
Bupropion Hydrochloride 24 hour ER Tablets
July 22, 2015
 Actavis began transitioning to new NDC numbers in February 2015.
 Par states the reason for the shortage was increased demand for product.
Article Link:
89
Chloroquine Tablets
July 22, 2015
 Global Pharmaceuticals discontinued chloroquine tablets in 2014.
 Rising discontinued chloroquine tablets in February 2015.
 Ranbaxy has chloroquine tablets on shortage due to third party supply issues.
 West-Ward cannot provide a reason for the shortage.
Article Link:
Dextrose 5% Injection Large Volume Bags
July 22, 2015
 Baxter states the shortage is due to increased demand.
 BBraun had 5% dextrose on allocation due to increased demand.
 Hospira states the shortage is due to increased demand and manufacturing delays.
Article Link:
Haloperidol Lactate Injection
July 22, 2015
 Patriot Pharmaceuticals states the reason for the shortage was increased demand.
 Sagent could not provide a reason for the shortage.
 Teva has haloperidol lactate on shortage due to manufacturing delays.
 West-Ward Pharmaceuticals' parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including haloperidol lactate injection.
West-Ward is not actively marketing haloperidol lactate at this time.
Article Link:
90
Hydroxychloroquine Sulfate Tablets
July 22, 2015
 Concordia acquired Plaquenil tablets from Covis in April 2015.
 Ranbaxy has hydroxychloroquine on shortage due to a regulatory issue.
 Sandoz states the hydroxychloroquine shortage is due to increased demand.
 Zydus could not provide a reason for hydroxychloroquine shortage.
 West-Ward discontinued hydroxychloroquine tablets in September 2014.
Article Link:
Levetiracetam Injection
July 22, 2015
 American Regent states the reason for the shortage is manufacturing delay.
 Caraco cannot provide a reason for the shortage.
 Fresenius states the reason for the shortage is manufacturing delay.
 Hospira states the reason for the shortage is increased demand.
 X-Gen states the reason for the shortage is change in manufacturing site.
Article Link:
Pantoprazole Tablets
July 22, 2015
 Aurobindo and Teva could not provide a reason for the shortage.
 Actavis discontinued pantoprazole 20 mg tablets in October 2014.
 Kremers Urban state the shortage is due to increased demand.
91

FDA imposed an import ban in mid-2013 on several Wockhardt products including
pantoprazole.
Article Link:
Propranolol Injection
July 22, 2015
 Ben Venue closed its plant in Bedford, Ohio in July 2014.
 Fresenius Kabi has propranolol injection on back order due to shortage of raw materials.
 West-Ward had propranolol injection on shortage due to manufacturing delays.
Article Link:
Thrombin Topical Solution (Bovine)
July 22, 2015
 Pfizer states the reason for the shortage is manufacturing delay.
 Recombinant thrombin topical solution products (Recothrom) are available and not
affected by this shortage.
Article Link:
Aminocaproic Acid Oral Presentations
July 23, 2015
 Akorn acquired Versapharm in 2014.
92


Akorn stopped distributing and marketing Versapharm’s aminocaproic acid product on
June 22, 2015.
Akorn launched Amicar oral solution and 500 mg tablets on June 29, 2015.
Article Link:
Benztropine Injection
July 23, 2015
 American Regent discontinued benztropine injection in May 2015.
 Fresenius Kabi recalled benztropine injection due to potential for glass particles in the
vials. The product is on long-term back order.
 Nexus divested benztropine injection to Fresenius Kabi in 2012.
Article Link:
Diltiazem Injection
July 23, 2015
 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:
93
Dipyridamole Injection
July 23, 2015
 Teva has temporarily discontinued their 2 mL and 10 mL products in order to increase
the package sizes.
Article Link:
Epinephrine Injection
July 23, 2015
 American Regent discontinued both epinephrine presentations in early-2015.
 Amphastar states the shortage is due to increased demand.
 BPI Labs received FDA approval for epinephrine injection in 2014 and the company
launched product in February 2015.
 Hospira has epinephrine syringes on shortage due to increased demand.
Article Link:
Ezetimibe and Atorvastatin Tablets
July 23, 2015
 In January 2014, Merck recalled all Liptruzet lots from wholesalers due to packaging
defects in the outer laminate foil pouches.
Article Link:
94
Leucovorin Calcium Injection
July 23, 2015
 Fresenius Kabi has leucovorin on shortage due to increase demand.
 Teva has leucovorin on allocation due to increased demand.
leucovorin calcium injection from Bedford in July 2014. West-Ward is not actively
marketing leucovorin calcium injection at this time.
Article Link:
Cefepime Injection
July 28, 2015
 Apotex could not provide a reason for the shortage.
 Baxter has cefepime on shortage due to increased demand.
 Fresenius Kabi has cefepime injection on shortage due to manufacturing delays.
 Sagent has cefepime injection on shortage due to increased demand.
 Hospira has Maxipime on shortage due to increased demand.
Article Link:
Cefazolin Injection
July 28, 2015
 BBraun has cefazolin on shortage due to increased demand.
 Fresenius Kabi has cefazolin on shortage due to increased demand.
 WG Critical Care has cefazolin on shortage due to increased demand. WG Critical Care
discontinued cefazolin 20 gram to focus on other strengths.
 Sandoz has cefazolin on shortage due to manufacturing delays.
 Hospira has cefazolin on shortage due to increased demand.
95

Sagent has cefazolin on shortage due to increased demand.
Article Link:
* Please refer to ASHP website for more information
96
NEW DRUGS COMING TO MARKET
PRODUCT
Odomzo
MFR
Novartis
ROUTE
PO
Epiduo Forte
(adapalene and
benzoyl
peroxide)
Envarsus XR
(tacrolimus
extended
release)
Galderma
Labs
Rexulti
(brexpiprazole)
Otsuka
Pharmaceu
ticals
PO
Entresto
(valsartan/
sacubitril)
Novartis
PO
Orkambi
(lumacaftor/
ivacaftor)
Vertex
Veloxis
Pharma
Topical
PO
PO
INDICATION
PHARMACOLOGY
advanced basal
cell carcinoma
that has
recurred
following
surgery or
radiation; or
those who are
not candidates
for surgery or
radiation
therapy
moderate to
severe acne
vulgaris
Hedgehog
signaling pathway
inhibitor
For the
prophylaxis of
organ rejection
in kidney
transplant
patients who
require or
desire
conversion from
a twice-daily
tacrolimus
product
schizophrenia
and as add-on
treatment to an
antidepressant
medication to
treat adults with
major
depressive
disorder (MDD)
Heart failure
Immunosuppressi
ve
For the
treatment of
cystic fibrosis in
patients 12
Retinoid/antiinfective
MARKET
RELEASE
TBD
Approval date07/24/2015
09/2015
4Q 2015
Serotonindopamine activity
modulator
08/2015
Angiotensin
receptorneprilysin
inhibitor (ARNI)
Cystic Fibrosis
transmembrane
conductance
regulator (CFTR)
3Q 2015
3Q 2015
97
PRODUCT
MFR
Tuxarin ER
(chlorphenirami
ne/codeine)
Spriaso
Firdapse
(amifampridine)
Catalyst
Pharmaceu
ticals
ixazomib
Takeda
ROUTE
PO
PO
PO
obeticholic acid
Intercept
Pharmaceu
ticals
PO
irinotecan
liposomal
( MM-398)
Merrimack
Pharmaceu
ticals
Liposo
mal
formula
tion
INDICATION
years and older,
who have the
F508del
mutation
Cough and cold
PHARMACOLOGY
Anti-tussive/
antihistamine
For the
treatment of
Lambert-Eaton
Myasthenic
Syndrome
(LEMS)
Acetylcholine
stimulant
For the
treatment of
relapsed or
refractory
multiple
myeloma, in
combination
with
lenalidomide
and
dexamethasone
primary biliary
cirrhosis
Proteasome
inhibitor
For the
treatment of
patients with
metastatic
adenocarcinoma
of the pancreas
who have been
previously
treated with
gemcitabinebased therapy
DNA
topoisomerase 1
inhibitor
MARKET
RELEASE
TBD
NDA
submission
date
07/22/2015
(orphan drug
designation)
NDA
submission
date
07/14/2015
(orphan drug
designation)
First-in-class
Farnesoid X
receptor agonist
NDA
submission
date
06/29/2015
(fast track
designation)
Priority
review
granted.
PDUFA date
10/25/2015
98

July 2015 - PerformRx

Transcription

Similar documents

Halls Universal

english - Sunpan

cover design - cloudfront.net

Calpine Northwest Geysers Enhanced Geothermal

Safe Power Injection of Contrast through Central Venous Catheters

principles of injection coding

Summer 2012 Newsletter - Nevada Society of Health

C lin ical In teg ratio n Track

Presentation - Muzzicycles

Allergy Bazaar – Station 2 Poster Layout Intracutaneous