December 2015 – January 2016

Transcription

December 2015 –
January 2016
Drug Information Update
Table of Contents
NEW GENERICS TO MARKET ........................................................................................................... 2
NEW DRUG ENTITIES....................................................................................................................... 3
NEW INDICATIONS (EXISTING DRUGS) ........................................................................................... 7
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ..................................................................... 8
STUDIES and RECENT TOPICS ........................................................................................................ 26
RECALLS ......................................................................................................................................... 34
CURRENT DRUG SHORTAGES ........................................................................................................ 96
NEW DRUGS COMING TO MARKET ............................................................................................ 132
Copyright© PerformRx, LLC 2016 All Rights Reserved
1
NEW GENERICS TO MARKET
GENERIC DRUG NAME
STRENGTH & DOSAGE
FORM
GENERIC
MANUFACTURER
BRAND NAME
APPROVAL
DATE
KETOROLAC TROMETHAMINE
60 mg/2 mL, SYRINGE
BD RX INC.
KETOROLAC
TROMETHAMINE
11/06/15
NEVIRAPINE
100 mg, TAB ER 24H
MYLAN
VIRAMUNE XR
11/10/15
MOLINDONE HCL
5 mg, 10mg, 25mg,
TABLET
COREPHARMA LLC
MOBAN
11/18/15
REPAGLINIDE/METFORMIN HCL
1 mg-500 mg, 2 mg-500
mg, TABLET
LUPIN PHARMACEU
PRANDIMET
11/18/15
LINEZOLID
100 mg/5 mL, SUSP
RECON
GREENSTONE LLC
ZYVOX
11/19/15
DUTASTERIDE/TAMSULOSIN HCL
0.5 mg-0.4 mg, CPMP
24HR
PAR PHARM
JALYN
11/17/15
EMOLLIENT COMBINATION NO.60
GEL (GRAM)
OCULUS INNOVATI
ZANABIN
11/18/15
PRAMIPEXOLE DI-HCL
2.25 mg,
TAB ER 24H
PAR PHARM
MIRAPEX ER
11/20/15
OLOPATADINE HCL
0.1 %, DROPS
ALVOGEN INC
PATANOL
12/10/15
MUPIROCIN/CL-HEX
GL/DMC/SILICO
2%-4%-5%, KIT
PATCHWERX LABS
DERMACINRX
SURGICAL
PHARMAPAK
12/15/15
EPTIFIBATIDE
0.75 mg/Ml, 2 mg/mL,
VIAL
AUROMEDICS PHAR
INTEGRILIN
12/14/15
2
NEW DRUG ENTITIES
DESCRIPTION
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PULMONARY
ANTIHYPERTENSIVES,
PROSTACYCLIN-TYPE
PROTECTIVES
BRAND NAME
GENERIC NAME
STRENGTH
NOTES
UPTRAVI
SELEXIPAG
200MCG
New Entity
UPTRAVI
SELEXIPAG
400 mcg
New Entity
UPTRAVI
SELEXIPAG
600 mcg
New Entity
UPTRAVI
SELEXIPAG
800 mcg
New Entity
UPTRAVI
SELEXIPAG
1,000 mcg
New Entity
UPTRAVI
SELEXIPAG
1,200 mcg
New Entity
UPTRAVI
SELEXIPAG
1,400 mcg
New Entity
UPTRAVI
SELEXIPAG
1,600 mcg
New Entity
UPTRAVI
SELEXIPAG
200 mcg
(140)-800
mcg (60)
New Entity
MICROCYN
HYDROGEL
HOCL/NA HY/NAMGF/NA
PH/NACL/WA
0.008 %
New Strength
BENDEKA
BENDAMUSTINE HCL
25 MG/ML
New Entity
ANTINEOPLASTIC ALKYLATING AGENTS
ANTINEOPLASTIC
SYSTEMIC ENZYME
INHIBITORS
ANTINEOPLASTIC EGF
RECEPTOR BLOCKER
MCLON ANTIBODY
PRENATAL VITAMIN
PREPARATIONS
METABOLIC DX ENZYME
REPLACEMENT,LYSO.ACID
LIP.DEF.
ALECENSA
ALECTINIB HYDROCHLORIDE
150 MG
New Entity
PORTRAZZA
NECITUMUMAB
800MG/50M
L
New Entity
VITATRUE
PRENATAL VIT
#105/IRON/FA/DHA
30-1.4-300
New Combination
KANUMA
SEBELIPASE ALFA
20 MG/10ML
New Entity
VITAMIN B PREPARATIONS
METHAVER
VIT B1/B2/B6/FA/
MECOBALAMIN
27 mg-29 mg50 mg-1 mg-2
mg
New Combination
METALLIC POISON,AGENTS
TO TREAT
FERRIPROX
DEFERIPRONE
100 mg/mL
New Strength and
Dosage Form
3
DESCRIPTION
PREGNANCY
FACILITATING/MAINTAINI
NG AGENT,HORMONAL
NSAIDS,
CYCLOOXYGENASE
INHIBITOR - TYPE
NSAIDS,
CYCLOOXYGENASE
INHIBITOR - TYPE
ANTINEOPLASTIC - ANTISLAMF7 MONOCLONAL
ANTIBODY
ANTINEOPLASTIC - ANTISLAMF7 MONOCLONAL
ANTIBODY
BRAND NAME
GENERIC NAME
STRENGTH
NOTES
MAKENA
HYDROXYPROGESTERONE
CAPROATE
250 mg/mL
STC and GCN
change
VIVLODEX
MELOXICAM,
SUBMICRONIZED
5 mg
New Formulation
VIVLODEX
MELOXICAM,
SUBMICRONIZED
10 mg
New Formulation
EMPLICITI
ELOTUZUMAB
300 mg
New Entity
EMPLICITI
ELOTUZUMAB
400 mg
New Entity
PATIROMER CALCIUM
SORBITEX
PATIROMER CALCIUM
SORBITEX
PATIROMER CALCIUM
SORBITEX
8.4 gram
New Entity
16.8 gram
New Entity
25.2 gram
New Entity
BUPIVACAINE
HCL
BUPIVACAINE HCL/PF
0.25 % 5
mL/hour 270
mL
New Strength; NO
Pricing
ANALGESICS, NARCOTICS
BELBUCA
BUPRENORPHINE HCL
75 mcg
BELBUCA
BUPRENORPHINE HCL
150 mcg
BELBUCA
BUPRENORPHINE HCL
300 mcg
BELBUCA
BUPRENORPHINE HCL
450 mcg
BELBUCA
BUPRENORPHINE HCL
600 mcg
BELBUCA
BUPRENORPHINE HCL
750 mcg
BELBUCA
BUPRENORPHINE HCL
900 mcg
ELECTROLYTE DEPLETERS
VELTASSA
VELTASSA
VELTASSA
LOCAL ANESTHETICS
SKIN TISSUE
REPLACEMENT
SKIN TISSUE
REPLACEMENT
TRUSKIN
TRUSKIN
HUMAN REGENERATIVE
TISSUE MTRX
HUMAN REGENERATIVE
TISSUE MTRX
New Strength,
Dosage Form, &
Route
New Strength,
Dosage Form, &
Route
New Strength,
Dosage Form, &
Route
New Strength,
Dosage Form, &
Route
New Strength,
Dosage Form, &
Route
New Strength,
Dosage Form, &
Route
New Strength,
Dosage Form, &
Route
2 cm X 4 cm
New Strength
4 cm X 8 cm
New Strength
4
DESCRIPTION
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
ANTIHEMOPHILIC
FACTORS
BRAND NAME
ADYNOVATE
ADYNOVATE
ADYNOVATE
ADYNOVATE
GENERIC NAME
STRENGTH
ANTIHEMO.FVIII,FULL
LENGTH PEG
ANTIHEMO.FVIII,FULL
LENGTH PEG
ANTIHEMO.FVIII,FULL
LENGTH PEG
ANTIHEMO.FVIII,FULL
LENGTH PEG
250 (+/-) unit
range
500 (+/-) unit
range
1,000 (+/-)
unit range
2,000 (+/-)
unit range
250 (+/-) unit
range
500 (+/-) unit
range
NOTES
New Entity
New Entity
New Entity
New Entity
FACTOR X PREPARATIONS
COAGADEX
COAGULATION FACTOR X
FACTOR X PREPARATIONS
COAGADEX
COAGULATION FACTOR X
NINLARO
IXAZOMIB CITRATE
2.3 mg
New Entity
NINLARO
IXAZOMIB CITRATE
3 mg
New Entity
NINLARO
IXAZOMIB CITRATE
4 mg
New Entity
VIBERZI
ELUXADOLINE
75 mg
New Entity
VIBERZI
ELUXADOLINE
100 mg
New Entity
TETRIX
PROTECTIVES COMBINATION
NO.2
NAPROPAK COOL
NAPROXEN
SODIUM/MENTHOL
550 mg-4 %
New Route and
Dosage Form
TAGRISSO
OSIMERTINIB MESYLATE
40 mg
New Entity
TAGRISSO
OSIMERTINIB MESYLATE
80 mg
New Entity
DARZALEX
DARATUMUMAB
100 mg/5 mL
(20 mg/mL)
New Entity
DARZALEX
DARATUMUMAB
400 mg/20
mL (20
mg/mL)
New Entity
SEEBRI
NEOHALER
GLYCOPYRROLATE
15.6 mcg
New Entity
HYDROMORPHO
NE HCL-0.9%
NACL
HYDROMORPHONE HCL IN
0.9% NACL
2 mg/mL
New Strength No
Pricing
ANTINEOPLASTIC
SYSTEMIC ENZYME
INHIBITORS
ANTINEOPLASTIC
SYSTEMIC ENZYME
INHIBITORS
ANTINEOPLASTIC
SYSTEMIC ENZYME
INHIBITORS
IBS AGENTS,MIXED OPIOID
RECEP
AGONISTS/ANTAGONISTS
IBS AGENTS,MIXED OPIOID
RECEP
AGONISTS/ANTAGONISTS
PROTECTIVES
NSAID & TOPICAL
IRRITANT COUNTERIRRITANT COMB.
ANTINEOPLASTIC
SYSTEMIC ENZYME
INHIBITORS
ANTINEOPLASTIC
SYSTEMIC ENZYME
INHIBITORS
ANTINEOPLASTIC - ANTICD38 MONOCLONAL
ANTIBODY
ANTINEOPLASTIC - ANTICD38 MONOCLONAL
ANTIBODY
ANTICHOLINERGICS,
ORALLY INHALED LONG
ACTING
New Entity
New Entity
New Combination
5
DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
NOTES
FLEXEPAX
CYCLOBENZAPRINE/CAPSAI/
MENTHOL
10 mg-0.0375
%-5 %
New Combination
UTIBRON
NEOHALER
INDACATEROL/GLYCOPYRROL
ATE
27.5 mcg15.6 mcg
New Entity
PEDIPAK
CICLOPIROX/UREA
8 %-20 %
New Combination
NAPROPAX
NAPROXEN/CAPSAICIN/MEN
THOL
500 mg0.0375 %-5 %
New Combination
GLEOSTINE
LOMUSTINE
5 mg
New Strength
COTELLIC
COBIMETINIB FUMARATE
20 mg
New Entity
ARV CMB-NRTI,N(T)RTI,
INTEGRASE INHIBITOR
GENVOYA
ELVITEG/COBI/EMTRIC/TENO
FO ALA
150 mg-150
mg-200 mg10 mg
New Entity
MONOCLONAL ANTIBODY
- INTERLEUKIN-5
ANTAGONISTS
NUCALA
MEPOLIZUMAB
(RECOMBINANT)
100 mg
New Entity
SKELETAL MUSCLE
RELAX.& TOP.IRRITANT
COUNTER-IRRIT
BETA-ADRENERGIC AND
ANTICHOLINERGIC
COMBINATIONS
TOPICAL ANTIFUNGALS
NSAID & TOPICAL
IRRITANT COUNTERIRRITANT COMB.
ANTINEOPLASTIC ALKYLATING AGENTS
ANTINEOPLASTIC - MEK1
AND MEK2 KINASE
INHIBITORS
6
NEW INDICATIONS (EXISTING DRUGS)
DRUG
NEW INDICATION
DATE OF APPROVAL
LINKS
HARVONI®
TREATMENT OF CHRONIC
HEPATITIS C INFECTION
WITH GENOTYPES 4,5,6
AND IN PATIENTS COINFECTED WITH HIV
PROPHYLAXIS OF DEEP
VEIN THROMBOSIS AND
PULMONARY EMBOLISM
IN PATIENTS FOLLOWING
HIP REPLACEMENT
SURGERY
USE AS A SINGLE AGENT
FOR THE TREATMENT OF
BRAF V600 WILD-TYPE
UNRESECTABLE OR
METASTATIC MELANOMA
POST-EXPOSURE
PROPHYLAXIS OF DISEASE
FOLLOWING SUSPECTED
OR CONFIRMED BACILLUS
ANTHRACIS EXPOSURE IN
CONJUCTION WITH
ANTIBACTERIAL DRUGS
EXPANDED AGE
INDICATION TO INCLUDE
MALES AGED 16
THROUGH 26
November 12, 2015
Harvoni® [package insert].
Gilead Sciences, Inc.
November 2015
November 23, 2015
Pradaxa® [package insert].
Boehringer Ingelheim
November 2015
November 24, 2015
Opdivo® [package insert].
Bristol-Myers
SquibbNovember 2015
November 24, 2015
BioThrax® [package
insert]. Emergent
BioSolutions Inc.
November 2015
December 15, 2015
Gardasil® [package insert].
Merck
December 2015
PRADAXA®
OPDIVO®
BIOTHRAX®
GARDASIL®
7
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New
Shared REMS Program
[Updated 11/19/2015]
ISSUE: FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving
the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge
about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low
number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be lifethreatening.
There are two parts to the changes in the requirements for treating patients with clozapine. First, FDA
clarified and enhanced the prescribing information for clozapine that explains how to monitor patients
for neutropenia and manage clozapine treatment. Second, FDA approved a new, shared risk evaluation
and mitigation strategy (REMS) called the Clozapine REMS Program. The revised prescribing information
and the Clozapine REMS Program will improve monitoring and management of patients with severe
neutropenia. The shared REMS is also expected to reduce the burden and possible confusion related to
having separate registries for individual clozapine medicines. The requirements to monitor, prescribe,
dispense, and receive all clozapine medicines are now incorporated into the Clozapine REMS Program.
BACKGROUND: Clozapine is an antipsychotic medicine used to treat schizophrenia in patients whose
symptoms are not controlled with standard antipsychotic treatment. It is also used to treat recurrent
suicidal behavior in patients with schizophrenia or schizoaffective disorder.
RECOMMENDATION: Patients who are currently treated with clozapine will be automatically transferred
to the Clozapine REMS Program. In order to prescribe and dispense clozapine, prescribers and
pharmacies will be required to be certified in the Clozapine REMS Program according to a specific
transition schedule starting October 12, 2015 (see Additional Information for Prescribers, Additional
Information for Pharmacies, and Additional Information for Patients and Caregivers sections of the Drug
Safety Communication for more details).
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/SafetyAlertsforHumanMedicalProducts/ucm
462229.htm
8
Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation
[Posted 11/23/2015]
ISSUE: The FDA wants to make health care providers aware of the possibility that hydrophilic and/or
hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices
and potentially cause serious injuries to patients. Coating separation can be caused by a number of
factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique
or using the wrong device for the procedure, to improper preconditioning of the device and improper
storage conditions as well as issues with device design or manufacturing processes. Based on current
information, the FDA believes the overall benefits of these devices continue to outweigh the risks.
However, health care providers should be aware of potential problems and consider certain actions
prior to use.
Since Jan. 1, 2010, there have been 11 recalls from various manufacturers associated with these
coatings peeling or flaking off of medical devices. The majority of the recalls were associated with
guidewires, but there have also been recalls for other types of devices including sheaths, retrieval
devices and embolization device delivery wires used in the vasculature.
In addition, since Jan. 1, 2014, the FDA has received approximately 500 Medical Device Reports (MDRs)
describing separation of hydrophilic and/or hydrophobic coatings on medical devices such as
guidewires, catheters, and introducers that had been used for cerebrovascular, cardiovascular and
peripheral vascular procedures. The majority of the reports were submitted for vascular guidewires and
over 75% of the reports describe device malfunctions.
Serious adverse events reported in these MDRs and in the scientific literature include pulmonary
embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue
necrosis, and death. Serious injuries associated with the peeling of coatings reported in MDRs included
the persistence of coating fragments in patients, requiring surgical intervention to mitigate the
consequences, adverse tissue reactions, and thrombosis.
BACKGROUND: The FDA has not concluded that any specific manufacturer or brand of these devices is
associated with higher risks than others. The cause of coating separation is multifactorial, and can be
associated with factors including device design, device manufacturing, and use. Current FDA analysis
suggests that use-related issues may be mitigated through proper device selection, preparation, and
other considerations noted below.



RECOMMENDATION: Based on current understanding of the benefits and risks of devices with these
coatings, the FDA believes that the overall benefits of these devices continue to outweigh the risks.
However, health care providers should consider the following information and actions to reduce the
potential of serious adverse events:
Be aware that many devices are designed, labeled and indicated for specific uses. For example, the
coating and performance of a device meant to be used in the peripheral vasculature may be different
than a device meant to be used in the cerebral vasculature.
Follow manufacturer’s instructions for proper device storage (e.g., shelf life, temperature, exposure to
light, etc.) as improper storage can impact the integrity of the coating.
When using two devices together (e.g., catheter and introducer sheath), ensure there is sufficient room
for one to pass safely within the other, taking into consideration the features of the device (e.g., curved
tip), and that some coatings may swell during use. For example, consider using a slightly larger French
size for the introducer sheath than the catheter so there is sufficient room between the devices. Review
the device labeling or consult the device manufacturer for further information.
9





Follow the manufacturer’s recommended preconditioning steps (if applicable) for the device.
Preconditioning activates the lubricious properties of some device coatings for optimal use.
 During preconditioning of the coating, use only the recommended solution (e.g., normal saline,
heparinized saline, sterile water, etc.). Solutions may not be interchangeable and may affect the
hydrophilic and/or hydrophobic coatings differently.
 Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this
may cause unpredictable changes in the coating which could affect the device safety and
performance.
 Avoid pre-soaking devices for longer than instructed, as this may impact the coating
performance.
 Avoid wiping the device with dry gauze as this may damage the device coating.
Use caution when manipulating, advancing and/or withdrawing these devices through needles, metal
cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels.
Manipulation, advancement and/or withdrawal past sharp or beveled edges may result in destruction
and/or separation of the outer coating which may lead to clinical adverse events.
Be aware that attempting to alter the shape of devices by bending, twisting, or similar methods may
compromise the coating integrity and that damage to the coating may not always be noticeable to the
naked eye.
Consider replacing a device if it does not move freely, is visibly kinked or otherwise damaged, or does
not perform as expected.
For further information on how to use a device safely, consult the labeling or contact the device
manufacturer.
Program:
ARTICLE LINK:
473924.htm
10
Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3
(Cholecalciferol)
[Posted 11/25/2015]
ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients of a
voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3
(Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports
of several adverse events potentially associated with these compounded capsules made by Glades
Drugs. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead
to life-threatening outcomes if left untreated. Patients suffering adverse effects from high Vitamin D
levels (Cholecalciferol) may not initially show symptoms. Therefore, patients who have received these
compounded capsules should stop taking this medication and immediately seek medical attention.
BACKGROUND: Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as
hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting,
and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures
and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure,
increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with
conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin
D toxicity.
RECOMMENDATION: Health care providers should quarantine and return any products subject to this
recall to the company at: Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476. Glades Drugs sent recall
letters to patients, attempted to contact them by phone, and called prescribing physicians.
Program:
ARTICLE LINK:
474599.htm
11
RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall - Wires May
Break and Separate from the Rotablator System
[Posted 11/27/2015]
ISSUE: Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and
separate from the rest of the Rotablator Rotational Atheroctomy System and cause serious injury such
as tamponade (blood in the sac around the heart causing decreased heart function), myocardial
infarction (heart attack), and migration of wire fragments elsewhere in the body. The company has
received three reports of this issue occurring, including one patient death following medical intervention
to remove the broken wire. Other interventions have included purposefully blocking off (occluding) the
affected artery, placing stents into the affected artery, and emergency heart surgery.
The use of affected product may cause serious adverse health consequences, including death.
BACKGROUND: The RotaWire Elite Guidewire and wireClip Torquer Guidewire are components of the
Rotablator Rotational Atherectomy System. The device is used to open narrowed arteries and improve
blood flow to the heart by cutting plaque from the artery wall (atherectomy).
RECOMMENDATION: Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate
Action Required letter to customers beginning October 9, 2015. The letter listed the following
instructions:
 Stop distributing and using these devices immediately.
 Return all affected products to Boston Scientific following the recall instructions in the letter.
 Distributors should notify any customer who may have received the product.
 Return the Recall Removal Reply Verification Tracking Form to Boston Scientific via email:
[email protected], or fax: 1-866-213-1806.
Program:
ARTICLE LINK:
474632.htm
12
Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall - Inaccurate Temperature
Display
[Posted 12/01/2015]
ISSUE: Bestmed, LLC, a medical device distributor, initiated a nationwide recall of the Digital Temple
Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd, featuring lot numbers S/N:
3612 through S/N: 3715, which were sold between October 2012 until the start of the recall in
November 2015.
Some Digital Temple Thermometers contain a manufacturing problem causing the affected
thermometers to display temperatures that are inaccurate and lower than actual body temperatures,
which potentially may cause the user or caregiver of the user to delay or forego seeking appropriate
care (generally an over-the-counter fever reduction medication) or receive more care than appropriate,
when relying solely on the temperature display on the thermometer.
See the Press Release for product photos.
BACKGROUND: The Digital Temple Thermometer is a hand-held thermometer and can be identified by
the DTT logo on the face. The back of the thermometer has a label with the KD-2201 designation. The
slash-mark (/) is not part of the model number. The lot number may be found on the bottom of the back
label, immediately after the designation “S/N:”
The Digital Temple Thermometer was distributed throughout the United States for direct sale and resale
through consumer retail stores, and through consumer retail stores in Canada under the following
packaging labels:
Bestmed
Good Neighbor
Kroger
Medline
Meijer
Premier Value
Safeway
Life Brand
Target
Top Care
Best Choice (Value Merchandise)
Western Family
RECOMMENDATION: Consumers who have a Digital Temple Thermometer should immediately stop
using the device. Consumers may return the thermometer to Bestmed for a replacement thermometer.
To arrange for the return and replacement of the thermometer or to ask questions, consumers should
contact the Bestmed via telephone at (877) 299-6700, facsimile at (303) 271-0163, or email at
[email protected], at any time.
ARTICLE LINK:
474790.htm
13
SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in
the Blood and Serious Urinary Tract Infections
[Posted 12/04/2015]
ISSUE: An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2
diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much
acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.
FDA issued a Drug Safety Communication in May 2015 warning about the risk of ketoacidosis with SGLT2
inhibitors and alerting that the Agency would continue to evaluate this safety issue. A review of the FDA
Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of
ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors (see the Drug Safety
Communication Data Summary). Symptoms of ketoacidosis include nausea, vomiting, abdominal pain,
tiredness, and trouble breathing.
FDA also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections
(pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from
March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to
an intensive care unit or dialysis in order to treat kidney failure.
As a result, FDA added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe
these two safety issues, and to provide prescribing and monitoring recommendations. FDA is also
requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required
enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous
postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized
follow-up to collect additional information, for a period of 5 years.
BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use
with diet and exercise to lower blood sugar in adults with type 2 diabetes. Medicines in the SGLT2
inhibitor class include canagliflozin, dapagliflozin, and empagliflozin.
RECOMMENDATION: Patients should stop taking their SGLT2 inhibitor and seek medical attention
immediately if they have any symptoms of ketoacidosis.
Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking
SGLT2 inhibitors who present with suggestive symptoms. Ketoacidosis associated with the use of SGLT2
inhibitors can occur even if the blood sugar level is not very high. If ketoacidosis is suspected, the SGLT2
inhibitor should be discontinued and treatment instituted promptly.
Program:
ARTICLE LINK:
475553.htm
14
Inspiration LS, 5i and 7i Ventilator Systems by eVent Medical: Class I Recall - May Shut Down without
Alarm
[Posted 12/07/2015]
ISSUE: eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the
ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the
ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse
health consequences, including injury or death.
This recall includes all models of eVent Medical LS, 5i and 7i Inspiration ventilators manufactured prior
to January 21, 2015. Distribution dates: February 14, 2013 to December 31, 2014
BACKGROUND: The company received one report of this issue occurring, with no injuries and no deaths.
RECOMMENDATION: The firm sent an urgent field safety notice to all customers on October 13, 2015
informing them of this issue. The letter advised customers to immediately discontinue use of the
affected ventilators until corrective actions could be taken. Customers with questions are instructed to
call eVent customer service: (949) 900-1917
To mitigate the risk of ventilator failure, the firm attached the instructions for removing the potentially
faulty component from the power board.
Program:
ARTICLE LINK:
475901.htm
15
Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA
Statement - FDA Warns of Potential Contamination
[Posted 12/09/2015]
ISSUE: FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient
(API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City,
Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to
compound sterile injectable drugs.
BACKGROUND: Taizhou manufactures APIs for repackagers and distributors, some of which sell these
products to compounding facilities in the United States. FDA contacted Taizhou through its US agent,
and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen
API it manufactures is not suitable for use in injectable drugs. Based on available information, the
affected API may potentially pose serious safety risks for U.S. patients who use or receive injectable drug
products compounded with the affected baclofen, especially when administered directly into the spinal
column. For example, use of baclofen API contaminated with particulate matter can result in serious
injury if injected directly into the spinal column and may also clog pumps used to administer the
medication. There is also a potential risk that the baclofen API may be contaminated by endotoxin or
microorganisms. FDA is continuing to investigate this incident.
RECOMMENDATION: FDA recommends that no baclofen API from Taizhou be used to manufacture or
compound any injectable drugs.
Program:
the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
ARTICLE LINK:
476514.htm
16
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk
Evaluation and Mitigation Strategy (REMS)
[Posted 12/16/2015]
ISSUE: FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing
type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The
REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.
In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines
after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone
medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea. FDA also
required the drug manufacturers to provide educational training to health care professionals about the
current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have
since fulfilled these requirements.
FDA has continued monitoring these medicines and identified no new pertinent safety information. FDA
will update the public if any new information becomes available.
BACKGROUND: Type 2 diabetes is a disease that can lead to serious complications such as kidney failure,
blindness, and premature death. Rosiglitazone can be used along with diet and exercise to control blood
sugar in adults with the disease.
RECOMMENDATION: The REMS is no longer necessary to ensure that the benefits of rosiglitazone
medicines outweigh their risks.
Program:
ARTICLE LINK:
477601.htm
17
Hand-held Laser Pointers: FDA Safety Communication - Risk of Eye and Skin Injuries
[Posted 12/22/2015]
ISSUE: FDA is reminding consumers about the risk of eye and skin injuries from exposure to products
containing lasers. Although most toys with lasers are safe and comply with performance standards,
some laser products such as hand-held laser pointers are being misused as toys. See FDA Safety
Communication for Laser Pointer Safety video.
FDA regulations limit the visible light power of hand-held laser pointers to 5 milliwatts (mW). Even at the
5mW legal limit, a laser aimed directly into the eye can cause temporary flash blindness. This will not
likely cause permanent injury, because most people have a protective reflexes such as looking away,
blinking, or making other movements to protect the eyes. However, reflections of the laser beam from
mirrors or metallic surfaces may not induce the protective reflex quickly enough to avoid injury. In
addition, intentionally keeping your eyes open and staring into a 5 mW beam will cause eye injury.
BACKGROUND: Lasers that emit more than 5mW visible light power can cause irreversible eye injury of
increasing severity as the power increases. High-powered laser pointers can irritate or even burn the
skin. Although illegal and potentially dangerous, high-powered laser pointers are available on the
Internet and in stores. FDA believes that many eye injuries from laser pointers go unreported.
Nonetheless, the FDA is aware of laser pointer injuries involving military personnel, researchers,
hobbyists and children. The FDA is aware of many child eye injuries caused when children play with laser
pointers. See FDA Safety Communication for description of incident reports.











RECOMMENDATION: The FDA wants to make consumers aware that they should not buy these lasers
for themselves or as gifts for others. FDA recommends the following:
Do NOT buy laser pointers for children or allow them to use them. These products are not toys.
Do NOT buy any laser pointer that emits more than 5 mW power and does not have the power printed
somewhere on the pointer or its packaging. Hand-held laser pointers over 5 mW and those that are not
properly labeled are illegal and potentially dangerous.
Never aim or shine a laser beam directly at any person, pet, vehicle, or aircraft. The startling effect and
temporary flash-blinding from a bright beam of light can cause serious accidents.
Do not aim a laser at any reflective surface such as a mirror or any other shiny surfaces where the beam
cannot be controlled.
Check the label of any laser pointer that you own. If it has a power greater than 5 mW, dispose of it
safely according to local environmental protection guidelines.
In the event of injury, immediately consult your eye doctor. Keep in mind that laser eye injuries are likely
to be painless.
We have found that some lasers are more powerful than the labeled or advertised power. If you are not
sure if your laser pointer is a high-powered laser, consider the following:
If the laser pointer is small and uses button batteries, its power is probably less than 5 mW.
If the laser pointer is pen-sized and runs on AA or AAA batteries, it's likely to be more powerful and may
exceed 5 mW.
If the laser pointer is flashlight-sized and runs on a cluster of AA or AAA batteries or runs on lithium
batteries, it likely exceeds 5 mW.
Laser pointers sold with battery chargers probably drain their batteries quickly and are very likely to be
overpowered.
Some laser pointers are sold with a removable cap that spreads the beam into a pattern. If used without
the cap, the beam becomes a single beam that could exceed 5 mW.
18



Sellers promoting high-powered laser pointers may use words such as: powerful, bright, ultra, super,
military, military grade, super bright, high power, ultra bright, strong, balloon pop, burn, burning,
adjustable focus, lithium battery, or lithium powered.
Videos or photos that show a laser with a bright, well-defined beam of light burning, melting, or popping
balloons are probably lasers that greatly exceed 5 mW.
If comments posted on the website describe the brightness or power of the product, then it likely
exceeds 5 mW.
Program:
ARTICLE LINK:
478746.htm
19
Chariot Guiding Sheath by Boston Scientific: Recall - Risk of Shaft Separation
UPDATED 12/23/2015. Recall classified as Class I. FDA Class I Recall notice issued
[Posted 12/11/2015]
ISSUE: Boston Scientific has voluntarily recalled the Chariot Guiding Sheath globally. The recall affects all
UPNs of the Chariot Guiding Sheaths. The recall was initiated on November 19, 2015 due to the risk of
shaft separation.
To date, Boston Scientific has received fourteen complaints for shaft separation, four of which involved
separation of the distal shaft. These events occurred during device preparation or use. The most severe
outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow
or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries
such as stroke, kidney damage or damage to the intestines or limbs.
BACKGROUND: These devices are intended for the introduction of interventional devices during
peripheral vascular procedures.
RECOMMENDATION: All affected healthcare facilities were previously advised to immediately
discontinue use of affected devices and return unused Chariot Guiding Sheaths to Boston Scientific.
Additionally, physicians are encouraged to contact all patients who have undergone procedures
involving Chariot to confirm their post-procedure status, as device shaft separation and embolized
fragments may not have been recognized at the time of the procedure.
Program:
ARTICLE LINK:
476848.htm
20
ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication - FUJIFILM
Medical Systems Validates Revised Reprocessing Instructions
[Posted 12/23/2015]
ISSUE: FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) issued revised, validated manual reprocessing
instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling.
The FDA reviewed the revised reprocessing instructions and the validation data and determined they
meet the Agency’s expectations. FDA recommends that facilities using Fuji’s ED-530XT duodenoscope
train staff on the new instructions and implement them as soon as possible.
BACKGROUND: As noted in FDA’s February 2015 Safety Communication, the complex design of
duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to
clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope
manufacturers as they modify and validate their reprocessing instructions to further enhance the safety
margin of their devices and show with a high degree of assurance that their reprocessing instructions,
when followed correctly, effectively clean and disinfect the duodenoscopes.
In May 2015, Fuji initiated testing to validate the revised reprocessing instructions and provided the
cleaning validation reports to FDA in July 2015. Between July and October 2015, the Agency continued
to work with Fuji to clarify and ultimately confirm that their cleaning and high-level disinfection
instructions met the Agency’s expectations. In October 2015, the FDA notified Fuji that the validation
data for the ED-530XT duodenoscope were acceptable and worked with the company as they developed
revised instructions for use.
RECOMMENDATION: The revised instructions include a more rigorous protocol for pre-cleaning, manual
cleaning and high-level disinfection procedures. They also incorporate the use of an additional
disposable brush (Model WB1318DE) to manually clean the distal end of the scope. The agency
reviewed the validation data and believes that when followed, the revised, validated reprocessing
instructions demonstrate consistent and reliable cleaning and high-level disinfection of the Fuji ED530XT duodenoscope. FDA recommends that facilities using Fuji’s ED-530XT duodenoscope train staff on
the new instructions and implement them as soon as possible. See the FDA Safety Communication for
details of the key changes to the reprocessing procedure for Fuji's ED-530XT duodenoscope.
While formal validation testing with the revised reprocessing instructions is ongoing for Fuji’s 250 and
450 duodenoscope models, FDA encourages health care facilities to apply the revised reprocessing
instructions for the ED-530XT duodenoscope to reprocess the 250 and 450 duodenoscope models. FDA
believes that the revised reprocessing instructions for the ED-530XT duodenoscope are more robust
because of additional pre-cleaning, cleaning and high-level disinfection steps and, for that reason,
should increase the safety margin of the 250 and 450 duodenoscope models. FDA recommends
implementing the revised reprocessing instructions as soon as possible.
ARTICLE LINK:
478949.htm
21
OmniPod Insulin Management System by Insulet: Field Safety Notification - Reported Cases
of Needle Mechanism Deployment Failure or Delay
UPDATED 12/23/2015. Recall classified as Class I. FDA Class I Recall notice issued.
[Posted 12/02/2015]
ISSUE: On November 2, 2015, Insulet Corporation initiated a lot-specific voluntary Field Safety
Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three
lots which were distributed internationally. This Notification is due to a slight increase in the reported
cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of
the needle mechanism. In the event a needle mechanism fails to deploy, the needle will not be inserted
and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose
(hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA).
The affected Pod lots have resulted in 66 Medical Device Reports, of which three required medical
intervention. See the Press Release for a listing of affected product lots.
BACKGROUND: The reported incidence of this product issue in the affected lots is approximately 1%-2%.
Once this issue was recognized, the Company corrected the manufacturing process and implemented
additional inspection steps. This Notification does not affect the OmniPod Personal Diabetes Manager
(PDM).
RECOMMENDATION: Insulet has notified its distributors and customers by email, FedEx, and phone
calls. Consumers who have Pods from the affected lots should ensure the needle mechanism has
deployed properly, and may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.
Program:
ARTICLE LINK:
475156.htm
22
Perseus A500 Anesthesia Workstation by Draeger: Class I Recall - Faulty Power Switch May
Cause Device to Stop Working
[Posted 12/23/2015]
ISSUE: Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may
fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail
and the patient may not receive either anesthesia or enough oxygen. This could cause patients to suffer
serious adverse health consequences, including injury or death. The recall includes all Draeger Perseus
A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015 with distribution
dates of February 1, 2015 to September 30, 2015. See the FDA Recall Notice for a link to a list of affected
serial numbers.
The company has received one report of this issue occurring, with no injuries and no deaths.
BACKGROUND: The Draeger Perseus A500 Anesthesia Workstation provides anesthesia and breathing
support for children and adults. This medical device is used in hospitals.
RECOMMENDATION: Draeger sent an urgent field safety notice to all customers with affected devices
on November 10, 2015, informing them of this issue. The letter indicates that the power switch of
affected workstations must be replaced. A Draeger service representative will contact customers to
schedule a replacement, free of charge. Until the replacement takes place, Draeger recommends that
users operate affected Perseus A500 workstations under continuous supervision. Customers with
questions are instructed to call Draeger technical support: 1-800-543-5047.
Program:
the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
ARTICLE LINK:
478940.htm
23
Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall – Potential for Test Result Error
[Posted 12/29/2015]
ISSUE: bioMérieux recallied the Etest PIP/TAZO/CON-4 PTC 256 because the test results from the
affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of
certain bacteria when it may not actually be effective in treating those bacteria. This error may result in
inappropriate treatment of a patient’s infection and could cause serious patient health consequences,
including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and
even death.
This recall includes all affected products with manufacturing dates December 20, 2012 to October 23,
2015, and distribution dates: January 24, 2013 to November 9, 2015. See the Recall Notice for a listing of
affected product reference and lot numbers.
BACKGROUND: The Etest PIP/TAZO/CON-4 PTC 256 is used by health care providers to help predict if
the antibiotic Piperacillin/Tazobactam (PIP/TAZO) will be effective in treating serious infections.







RECOMMENDATION: bioMérieux sent an Urgent Product Removal Notice to customers beginning on
November 24, 2015. The letter issued the following instructions:
Review the notification and ensure appropriate laboratory personnel are aware of the notice.
Stop using the affected product and discard any remaining inventory of the affected product.
Discuss any concerns regarding previously reported results with your Laboratory Medical Director to
determine the appropriate course of action.
Complete and return the Acknowledgement Form by fax to confirm receipt of the notice.
Questions should be directed to bioMérieux’s Customer Care Center: 1-800-682-2666, Monday through
Friday between the hours of 7 a.m. and 7 p.m. Eastern Standard Time.
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
ARTICLE LINK:
479208.htm
24
4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and
8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by
Pharmedium: Recall – Discoloration
[Posted 12/31/2015]
ISSUE: PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate
(16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine
Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital
customers. They have received complaints from hospitals for products that have been found to exhibit a
slight discoloration in the admixture. The drug manufacturer's prescribing information advises not to use
the product if it is discolored. For affected lots, see the firm press release.
Discoloration is indicative of degradation and could result in decreased potency due to oxidation of
Norepinephrine Bitartrate. Decreased potency may result in a delayof achieving desired therapeutic
effect. PharMEDium Services has not received any reports of adverse events to date related to this
recall.
BACKGROUND: The product is used for blood pressure control in certain acute hypotensive states and is
packaged in a 250 mL Viaflex Bag.
RECOMMENDATION: Hospital pharmacies that have the recalled 4mg Norepinephrine Bitartrate
(16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate
(32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag in stock should stop using and discard
per the hospital destruction policy. Hospitals that may have shared these products with other hospitals
should contact those hospitals that received the products.
Hospitals or other healthcare providers with questions regarding this recall can contact PharMEDium
Services by calling 847-457-2244 or email at [email protected] Monday through Friday, 8:00
AM to 5:00 PM, Central Standard Time. Patients should contact their physician or healthcare provider if
they have experienced any problems that may be related to taking or using this drug product
the use of these products to the FDA's MedWatch SafetyInformation and Adverse Event Reporting
Program:
ARTICLE LINK:
479680.htm
25
STUDIES and RECENT TOPICS
Lilly diabetes drug cuts heart failure death, hospitalization: study
November 9, 2015
Eli Lilly's new diabetes drug Jardiance significantly cut the risk of heart-related death and hospitalization
for heart failure in patients with type 2 diabetes who are at high risk for serious heart problems,
according to data from a large study presented on Monday.
Article Link:
http://www.reuters.com/article/us-health-heart-elilillyidUSKCN0SY1TU20151109#3PGsZWXKBcJWJui5.97
Side Effects Cause Some to Stop Taking Blood Thinner Brilinta
November 10, 2015
Side effects like bleeding or shortness of breath cause some heart attack survivors to stop taking a
potentially lifesaving new blood thinner during clinical trials, researchers report. About one in five
people assigned to take the highest dose of the blood thinner Brilinta (ticagrelor) during clinical trials
stopped taking the drug due to side effects, the new research found.
Article Link:
http://consumer.healthday.com/cardiovascular-health-information-20/heart-attack-management-andprevention-news-365/side-effects-cause-some-to-stop-taking-blood-thinner-brilinta-705142.html
Sorry, kids. There’s a nationwide FluMist shortage, so you’ll probably have to get a
shot.
November 11, 2015
Since the FluMist nasal spray was approved by the Food and Drug Administration in 2007, millions of
children have used it to avoid the painful ouch of the standard flu vaccine injection.
But this year, if you want to get the flu vaccine right away, you may have a hard time finding the nasal
spray. Pediatricians, pharmacists, workplace nurses and schools across the country are reporting that
they are out of FluMist -- which is approved for ages 2 to 49 --due to a nationwide shortage.
Article Link:
https://www.washingtonpost.com/news/to-your-health/wp/2015/11/11/sorry-kids-theres-anationwide-flumist-shortage-so-youll-probably-have-to-get-a-shot/
26
CDC: Half of Americans With HTN Don't Have BP Under Control
November 12, 2015
About 47 percent of individuals with hypertension do not have the condition under control, through
either lifestyle changes or medications, according to a November data brief published by the U.S.
Centers for Disease Control and Prevention's National Center for Health Statistics.
Article Link:
http://www.physiciansbriefing.com/Article.asp?AID=705230
Exclusive: U.S. drug benefit managers clamp down on specialty pharmacies
November 15, 2015
In recent days, the largest U.S. managers of private prescription drug benefits have cut off at least eight
pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug
prices, officials at the benefit managers told Reuters.
Article Link:
http://news.yahoo.com/exclusive-u-drug-benefit-managers-clamp-down-specialty-164236225-finance.html
Lucentis more effective than lasers for reversing diabetes-induced blindness in new
study
November 17, 2015
Standard treatments for PDR are associated with several adverse side effects. For example, laser therapy
is associated with reduced night vision and loss of peripheral vision, as well as sometimes worsening
existing diabetic macular edema.
Article Link:
http://www.biopharmadive.com/news/lucentis-more-effective-than-lasers-for-reversing-diabetesinduced-blindnes/409352/
27
Certain Antibiotic Might Combat Children's Wheezing Episodes
November 17, 2015
Quickly clobbering a cold with a certain antibiotic might help kids who are prone to severe respiratory
tract infections, a new study suggests. Doctors generally are advised not to prescribe antibiotics for
routine viruses like the common cold. But for especially vulnerable children, one antibiotic in particular - azithromycin -- might thwart more serious illness, researchers said.
Article Link:
http://consumer.healthday.com/infectious-disease-information-21/antibiotics-news-30/certainantibiotic-might-combat-preschoolers-wheezing-episodes-705331.html
Black Box Warnings Spur Decline in SSRI Rx
November 30, 2015
Black box warnings placed on antidepressants in October of 2004 pertaining to children and in May 2007
for young adults ages 18 to 24 due to the increased risk of suicidal thinking or behavior seemed to
influence dosing among prescribers, researchers found, with lower doses prescribed after the FDA
warnings appeared.
Article Link:
http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/54924
FDA approves rosuvastatin for use in youth aged 8 to 17 with HeFH
November 30, 2015
AstraZeneca announced that the FDA has approved rosuvastatin to reduce total cholesterol,
LDL and apolipoprotein B in pediatric patients aged 8 to 17 years with heterozygous familial
hypercholesterolemia.
According to the company, rosuvastatin (Crestor, AstraZeneca) can now be administered to that patient
population after failure of an adequate-length attempt at control through diet if LDL > 190 mg/dL or if
LDL > 160 mg/dL and the patient has a family history of CVD or at least two other risk factors for CVD.
Article Link:
http://www.healio.com/cardiology/chd-prevention/news/online/%7Bdbf22c2d-37cb-4968-8c31f8b79766cd63%7D/fda-approves-rosuvastatin-for-use-in-youth-aged-8-to-17-withhefh?sc_trk=internalsearch
28
Clozapine Benefits Those With Tx-Resistant Schizophrenia
December 1, 2015
Clozapine reduces symptoms in patients with schizophrenia who don't benefit from other antipsychotic
medications, according to research published online Nov. 6 in The American Journal of Psychiatry.
The findings were culled from an analysis of Medicaid data on 6,246 patients with treatment resistant
schizophrenia. The researchers assessed outcomes of a cohort of patients with schizophrenia and
evidence of treatment resistance that initiated clozapine (3,123 patients) and in a propensity scorematched cohort that initiated a standard antipsychotic (3,123 patients).
Article Link:
http://www.physiciansbriefing.com/Article.asp?AID=705679
Metformin May Not Help Obese Teens With Type 1 Diabetes
December 1, 2015
Metformin is the standby drug for millions of people with type 2 diabetes, but a new study finds that
adding it to insulin therapy won't boost blood sugar control for overweight teens with type 1 diabetes.
In type 1 diabetes, which comprises about 5 percent of diabetes cases, the body is unable to produce
the insulin it needs. So, supplemental insulin is a must for people with the disease.
Article Link:
http://consumer.healthday.com/diabetes-information-10/misc-diabetes-news-181/metformin-may-nothelp-obese-teens-with-type-1-diabetes-705653.html
Brigham researchers say Novartis drug can help cardiac patients live longer
December 2, 2015
Researchers at Brigham and Women’s Hospital have discovered even more promising data around a
Novartis drug for heart failure, saying that the drug increased life expectancy by nearly two years
The research, published in the Dec. 3 issue of the New England Journal of Medicine, showed that
patients that had reduced ejection fraction form — which is a reduced capability to pump blood from
the heart — that took sacubitril-valsartan increased their life expectancy of one and a half to two years,
compared to current treatments.
Article Link:
http://www.bizjournals.com/boston/blog/bioflash/2015/12/brigham-researchers-say-novartis-drugcan-help.html
29
Anti-Aging Drug Could Extend Our Crazy-Old-Lady Years
December 2, 2015
Over the summer, we heard about a definitely-maybe magical anti-aging drug that already exists: the
diabetes medication metformin. Researchers have already shown that metformin extends the life of
mice and helped roundworms stay healthier longer; observational studies in humans found that
diabetics taking the drug lived longer than people without diabetes.
It's thought to be beneficial because it prevents your body from releasing extra sugar into your blood
and slows the rate of cell turnover. Now, the U.S. Food and Drug Administration has green-lit a clinical
trial in humans called Targeting Aging with Metformin, or TAME. Cue headlines about us living to 120, in
good health, no less.
Article Link:
http://nymag.com/thecut/2015/12/anti-aging-drug-metformin-human-trial.html
Unmet Gout Tx Targets: Stay or Switch?
December 4, 2015
Patients with gout who switched to febuxostat (Uloric) after an inadequate response to allopurinol were
more successful at achieving the target serum urate level than those who continued on allopurinol, a
retrospective study found.
Article Link:
http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/55017
Safe to Take Antidepressants With Tamoxifen: Study
December 4, 2015
Breast cancer survivors who take antidepressants while on the cancer drug tamoxifen are not at
increased risk for a return of their cancer, a new study finds. Tamoxifen is widely used to reduce the risk
of breast cancer returning. But it can cause unpleasant side effects, including hot flashes and
depression. As a result, nearly half of the 2.4 million breast cancer survivors in the United States take
antidepressants, the study authors said.
Article Link:
http://consumer.healthday.com/mental-health-information-25/antidepressants-news-723/safe-to-takeantidepressants-with-tamoxifen-study-says-705771.html
30
Warfarin Safe in Cancer-Related VTE
December 8, 2015
Switching anticoagulation therapy from low molecular-weight heparin (LMWH) to warfarin after 6
months for patients with a cancer-associated thrombosis appeared safe in a registry study.
In a retrospective analysis of more than 1,500 patients, those who switched to oral warfarin from
injectable LMWH had no increase in the risk of recurrent venous thromboembolism
(VTE), according to Chatree Chai-Adisaksopha, MD, of McMaster University in Hamilton,
Ontario.
Article Link:
http://www.medpagetoday.com/Cardiology/VenousThrombosis/55090
FDA Panel Set to Scrutinize Codeine Safety in Kids
December 9, 2015
SILVER SPRING, Md. -- FDA advisors will tackle the safety of codeine use in children under 18 years in a
meeting Thursday, addressing concerns that the drug's benefits may not outweigh its risks -- ever.
The Pulmonary-Allergy Drugs (PADC) and Drug Safety and Risk Management committees will meet on
Thursday to "discuss the available safety data with codeine use in children for cough or analgesia and to
obtain input on whether the use of codeine in children should be restricted further beyond the current
Contraindication and whether codeine should be available as an antitussive through the OTC Drug
Monograph," according to the FDA's briefing documents.
Article Link:
http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/55132
IBD Patients Are Taking Steroids for Too Long
December 11, 2015
A study in BMC Pharmacology & Toxicology suggests that measures in place to limit systemic steroid use
for patients with inflammatory bowel disease (IBD) are not as effective as they need to be. The study
authors suggest a two-part model to examine drug utilization patterns that would separately consider
factors associated with initiation and duration of therapy.
Article Link:
http://www.hcplive.com/conference-coverage/aibd-2015/ibd-patients-are-taking-steroids-for-too-long
31
Hospitals launch specialty pharmacies to curb drug costs
December 12, 2015
With specialty drug spending soaring 60% in the past five years, large health systems have jumped into
the specialty pharmacy business to assert some control over those costs by dispensing the drugs to their
patients and covered employees.
Article Link:
http://www.modernhealthcare.com/article/20151212/MAGAZINE/312129963/hospitals-launchspecialty-pharmacies-to-curb-drug-costs
Some Benefit With Entyvio for Arthritis in Crohn's
December 13, 2015
Treatment with vedolizumab (Entyvio) among patients with Crohn's disease may be associated with
some benefits for the disease's extraintestinal manifestations, although statistically significant
differences compared with placebo were not seen in a post hoc analysis.
Article Link:
http://www.medpagetoday.com/MeetingCoverage/AIBD/55203
Taking antidepressants during pregnancy linked to increased risk of autism
December 14, 2015
Children are more likely to be diagnosed with autism if their mothers took antidepressants during
pregnancy, a new study shows.
In the new study, women who took antidepressants in the last six months of pregnancy were 87% more
likely to have a child later diagnosed with autism. Doctors saw no increase in autism rates in women
who took medication for depression in the first three months of pregnancy, according to the study,
published online Monday in JAMA Pediatrics.
Article Link:
http://www.usatoday.com/story/news/2015/12/14/taking-antidepressants-during-pregnancy-linkedincreased-risk-autism/77277946/
32
Psychiatric drug—not antibiotic—messes with gut microbes, spurs obesity
December 15, 2015
A drug that helps your mind may turn your gut microbes—and waistline—against you.In a series of
experiments in mice, researchers found that a common drug used to treat psychiatric illnesses, including
autism and bipolar disorder, alters the gut microbial community. Those changes caused the mice to burn
fewer calories while resting and gain weight, researchers report in EBioMedicine. The finding, which
lines up with weight gain seen in patients, suggests that drugs other than antibiotics can easily mess
with a person’s microbes, which in turn profoundly influence metabolism, weight, and overall health.
Article Link:
http://arstechnica.com/science/2015/12/psychiatric-drug-not-antibiotic-messes-with-gut-microbesspurs-obesity/
Under pressure, CDC delays release of opioid prescribing guidelines
December 15, 2015
Under mounting criticism, the Centers for Disease Control and Prevention has delayed plans to next
month release controversial opioid prescribing guidelines for primary care physicians. Instead, the
guidelines will now be issued sometime later in the year, but an agency spokeswoman did not mention a
specific timeframe.
Article Link:
http://www.statnews.com/pharmalot/2015/12/15/cdc-opioid-painkiller/
33
RECALLS*
Product
Type
Product Description
Code Info
Class
Reason for
Recall
Recalling Firm
CLASS I
Drugs
Drugs
LiDa DAIDAIHUA (also
packaged as LiDa
DAIDAIHUAJIAONANG),
capsules, packaged in 1.6oz
box 30 capsules per box
all lots
Class I
KABOOM action strips,
Sexual Performance Strips,
packaged in 6.4oz box 12
strips per box
all lots
Class I
Marketed
Without An
Approved
NDA/ANDA:
presence of
undeclared
Sibutramine
and
Phenolphthalei
n.
Marketed
Without An
Approved
NDA/ANDA:
presence of
undeclared
Sulfoaildenafil.
Blue Square
Market, Inc
Blue Square
Market, Inc.
CLASS II
Drugs
Drugs
ACETYLCYSTEINE 10%
OPHTALMIC, 10 mL
dropper bottle
Lot Numbers:
20150209@41 BUD:
10/2/2015,
20150909@2 BUD:
10/9/2015
Class II
Alprostadil (PGE-1), 5 mL
(40 mcg/mL) in 10 mL
Multi-Dose Vial
Lot Numbers:
20150408@10 BUD:
1/27/2015;
20151407@11 BUD:
1/10/2015;
20151604@8
9/16/2015;
20152703@2
9/16/2015
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
US
Compounding
Inc
US
Compounding
Inc
34
Product
Type
Drugs
Drugs
Drugs
Product Description
Code Info
Betamethasone Combo 10
mL (7 mg/mL), 10 mL
Multi-Dose Vial
Lot Numbers:
20150104@4 BUD:
9/27/2015;
20150105@1 BUD:
10/27/2015;
20150107@25 BUD:
12/27/2015;
20150306@44 BUD:
11/29/2015;
20150704@49 BUD:
10/3/2015;
20150705@5 BUD:
11/1/2015;
20151106@17 BUD:
12/7/2015;
20151305@5 BUD:
11/8/2015;
20151806@19 BUD:
12/13/2015;
20152005@29 BUD:
11/15/2015;
20152205@7 BUD:
11/16/2015
Class
Class II
Betamethasone Combo PF
2 mL (6 mg/mL) 10 mL
Multi-Dose Vial
Lot Numbers:
20150206@41 BUD:
11/28/2015;
20151603@58 BUD:
9/12/2015;
20152007@43 BUD:
1/16/2016;
20152104@41 BUD:
10/18/2015
Class II
Betamethasone SP, 2 mL (6
mg/mL),10 mL Multi-Dose
Vial
Lot Numbers:
20150806@9 BUD:
12/5/2015;
20152107@38 BUD:
Class II
Reason for
Recall
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
35
Product
Type
Product Description
Code Info
Class
1/17/2016
Drugs
Betamethasone SP PF (12
mg/mL), 2 mL Single Dose
Vial
Lot Numbers:
20150107@27
BUD:12/28/2015;
20150704@5 BUD:
10/4/2015;
20152005@22 BUD:
11/16/2015
Drugs
Bi-Mix (Papaverine 30
mg/mL, Phentolamine 1
mg/mL), 5 mL Multi-Dose
Vial
Lot Numbers:
20152303@7 BUD:
9/19/2015
Drugs
Brompheniramine Maleate
(10 mg/mL), 10 mL MultiDose Vial
Lot Numbers:
20151205@11 BUD:
11/7/2015;
20151806@11 BUD:
12/15/2015
Class II
Class II
Class II
Reason for
Recall
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
36
Product
Type
Product Description
Code Info
Class
Drugs
Cyclo/PE/Trop PF
(1%/2.5%/1%), 3 mL
dropper bottle
Lot Numbers:
20150707@5 BUD:
1/3/2016
Class II
Cyclo/PE/Tropic/Ketor
(1%/2.5%/1%/0.5%), 10 mL
Opthalmic dropper bottle
Lot Numbers:
20152707@22 BUD:
10/25/2015;
20150707@9 BUD:
10/5/2015;
20152906@15 BUD:
9/27/2015;
20152907@2 BUD:
10/27/2015
Class II
Cyclopent/PE/Tropic 2mL
(1%/2.5%/0.25%), 2 mL
dropper bottles
Lot Numbers:
20151806@22 BUD:
12/15/2015;
20152306@36 BUD:
12/20/2015
Class II
Drugs
Drugs
Reason for
Recall
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
37
Product
Type
Product Description
Code Info
Dapiprazole
(Diluent+Powder) 0.5% in 5
mL vial
Lot Numbers:
20150506@6 BUD:
11/28/2015;
20150805@40 BUD:
10/31/2015;
20151206@7 BUD:
12/5/2015;
20151704@21 BUD:
10/10/2015;
20152003@43 BUD:
9/12/2015
Dex LA 8 (Dexamethasone
acetate (8 mg/mL), 10 mL
Multi-Dose Vial
Lot Numbers:
20150107@23 BUD:
12/28/2015;
20151305@43 BUD:
11/9/2015;
20151307@18 BUD:
1/9/2016;
20152204@33 BUD:
10/19/2015;
20152606@1 BUD:
12/22/2015;
20153003@34 BUD:
9/26/2015
Class II
Drugs
Dex Combo
(Dexamethasone acetate
8mg/mL, dexamethasone
sodium phosphate USP, 4
mg/mL),30 mL Multi-Dose
Vial
Lot Numbers:
20150705@1 BUD:
11/2/2015;
20151706@49 BUD:
12/14/2015;
20152204@21 BUD:
10/19/2015;
20152303@26 BUD:
9/19/2015
Class II
Drugs
Dexamethasone Sodium
Lot Numbers:
Class II
Drugs
Drugs
Class
Class II
Reason for
Recall
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
US
38
Product
Type
Product Description
Code Info
Phosphate PF (10 mg/mL),
2 mL Single Use Vial
20151407@13 BUD:
1/10/2016
ePHEDrine Sulfate PF (50
mg/10 mL), 10 mL SingleUse Syringe
Lot Numbers:
20151706@45 BUD:
12/14/2015;
20151707@16 BUD:
1/13/2016;
20150904@17 BUD:
10/6/2015;
20151703@19 BUD:
9/13/2015;
20153003@7 BUD:
9/26/2015;
20153006@42 BUD:
12/27/2015
Drugs
Fentanyl PF 50 mL (25
mcg/mL), 10 mL Single Use
Syringe
Lot Numbers:
20150604@20 BUD:
10/3/2015;
20152306@20 BUD:
12/20/2015;
20152403@28 BUD:
9/20/2015
Drugs
Glycopyrrolate USP ( 1
mg/5 mL), 5 mL Single Use
syringe
Lot Numbers:
20150306@57 BUD:
11/30/2015;
20151305@40 BUD:
11/9/2015;
Drugs
Class
Class II
Class II
Class II
Reason for
Recall
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
Recalling Firm
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
39
Product
Type
Product Description
Code Info
Class
20151404@36 BUD:
10/11/2015;
20151603@3 BUD:
9/12/2015;
20152005@40 BUD:
11/16/2015;
20153003@10 BUD:
9/26/2015
Drugs
HCG/B12 (5,000 units, 0.6
mg) 5 mL, Multi-Dose Vial
Drugs
Hyaluronic Acid/Lidocaine
PF (20 mg/1%), 2 mL
Lot Numbers:
20150806@22 BUD:
12/5/2015;
20150106@12 BUD:
11/28/2015;
20150106@20 BUD:
11/28/2015;
20150604@2 BUD:
10/3/2015;
20150604@2 BUD:
10/3/2015;
20150607@9 BUD:
1/2/2016;
20150806@22 BUD:
12/5/2015;
20151304@13 BUD:
10/10/2015;
20151506@22 BUD:
12/12/2015;
20152007@4 BUD:
1/16/2016;
20152206@20 BUD:
12/19/2015;
20152303@11 BUD:
9/19/2015;
20152303@2 BUD:
9/19/2015;
20152704@2 BUD:
10/24/2015;
20152707@3 BUD:
1/23/2016;
20152707@9 BUD:
1/23/2016;
20152303@11 BUD:
9/19/2015
Lot Numbers:
20150906@32 BUD:
Reason for
Recall
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Recalling Firm
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
US
Compounding
40
Product
Type
Drugs
Drugs
Drugs
Product Description
Code Info
Single-Use Syringe
12/6/2015,
20150906@33 BUD:
12/6/2015,
20151105@45 BUD:
11/7/2015,
20151205@12 BUD:
11/8/2015,
20151404@39 BUD:
10/11/2015
PF (60 mg/2%), 3 mL Single
Use Syringe
Lot Numbers:
20151105@39 BUD:
11/7/2015
Class II
(20 mg/1%/2 mL), 3 mL
Single Use Syringe
Lot Numbers:
20151806@30 BUD:
11/7/2015,
20152306@38 BUD:
11/7/2015,
20151806@29 BUD:
11/7/2015,
20151903@30 BUD:
9/15/2015
Class II
Hyaluronidase PF (150
units/mL) in 1 mL SingleUse Vial
Lot Numbers:
20150608@1 BUD:
10/5/2015,
20152707@4 BUD:
9/23/2015
Class II
Class
Reason for
Recall
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
Recalling Firm
Inc
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
41
Product
Type
Product Description
Code Info
Class
Drugs
Choline chloride 50 mg/mL,
Inositol 50 mg/mL
Cyanocobalamin 1000
mcg/mL, 30 mL Multi-Dose
Vial
Lot Numbers:
20150405@59 BUD:
10/31/2015
Class II
Drugs
L-Cysteine PF (50 mg/mL),
10 mL Single Dose Vial
Lot Numbers:
20151906@10 BUD:
9/17/2015
Class II
Lidocaine 1% PF(100 mg/10
mL),10 mL Single Use
Syringe
Lot Numbers:
20150104@21 BUD:
9/28/2015,
20150406@26 BUD:
12/1/2015,
20151704@1 BUD:
10/14/2015,
20152004@10 BUD:
10/17/2015
Class II
Drugs
Reason for
Recall
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
42
Product
Type
Product Description
Code Info
Class
Drugs
Lincomycin/Lidocaine (300
mg/1%/mL), 10 mL MultiDose Vial
Lot Numbers:
20150505@1 BUD:
10/31/2015
Class II
Drugs
MedroxyPROGESTERone/Li
docaine (150 mg/mL/1%)
10 mL Multi-Dose Vial
Lot Numbers:
20150705@13 BUD:
11/3/2015,
20151805@36 BUD:
11/14/2015
Drugs
Methylcobalamin (12.5
mg/mL), 2.5 mL Multi-Dose
Vial
Lot Numbers:
20152105@38 BUD:
11/17/2015,
20152705@34 BUD:
11/23/2015
Class II
Class II
Reason for
Recall
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
43
Product
Type
Drugs
Drugs
Drugs
Product Description
Code Info
Class
MethylPREDNISolone (100
mg/mL) 10 mL Multi-Dose
Vial
Lot Numbers:
20150806@41 BUD:
12/5/2015,
20151205@67 BUD:
11/8/2015,
20151504@24 BUD:
10/12/2015,
20152306@30 BUD:
12/20/2015,
20152603@27 BUD:
9/22/2015
Class II
MethylPREDNISolone PF
(80 mg/mL), 1 mL Single
Use Vial
Methylprednisolone/Lidoca
ine (40 mg/mL/1%) 10 mL
Multi-Dose Vial
Lot Numbers:
20150806@35 BUD:
12/5/2015,
20151006@34 BUD:
12/7/2015,
20152303@42 BUD:
9/19/2015,
20152704@16 BUD:
10/24/2015,
20152906@26 BUD:
12/26/2015,
20153007@19 BUD:
1/26/2016,
20151703@6 BUD:
9/13/2015,
20151806@12 BUD:
12/15/2015
Lot Numbers:
20150707@31 BUD:
1/3/2016,
20150707@36 BUD:
1/3/2016,
20151106@19 BUD:
12/8/2015,
20151604@24 BUD:
10/13/2015,
20151606@20 BUD:
12/13/2015,
20151805@60 BUD:
11/14/2015,
20152105@35 BUD:
11/17/2015,
Reason for
Recall
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Recalling Firm
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
44
Product
Type
Product Description
Code Info
Class
Reason for
Recall
Recalling Firm
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
20153103@13 BUD:
9/27/2015
Drugs
Drugs
Drugs
MIC Combo (Methionine
25 mg/mL, Inositol 50
mg/mL, Choline chloride 50
mg/mL, Cyanocobalamin
1000 mcg/mL), 30 mL
Multi-Dose Vial
Lot Numbers:
20150705@32 BUD:
11/2/2015,
20151304@17 BUD:
10/10/2015,
20151905@56 BUD:
11/15/2015,
20152004@9 BUD:
10/17/2015
MIC-Combo, 30 mL MultiDose Vial, For Deep IM
Injection Only
Lot Code:
20150105@18 BUD:
10/28/2015,
20150805@34 BUD:
11/4/2015,
20152603@12 BUD:
9/21/2015,
20153004@20 BUD:
10/27/2015,
20150805@34 BUD:
11/4/2015,
20152603@12 BUD:
9/21/2015,
20153004@20 BUD:
10/27/2015
Morphine PF (2 mg/2 mL),
2 mL Single Use Vial
Lot Code: 20151008@2
BUD: 2/6/2016,
20151307@2 BUD:
1/9/2016,
20153107@27 BUD:
1/27/2016
45
Product
Type
Drugs
Drugs
Drugs
Product Description
Neostigmine (5 mg/5 mL),
5 mL Single Use Syringe
Omnipaque 300 (600 mg/2
mL), 2 mL Single Use Vial
Phenylephrine 1.5%/
Lidocaine 1%, 1 mL Single
Use Vial
Code Info
Lot Code:
20150106@48 BUD:
11/28/2015,
20150106@49 BUD:
11/28/2015,
20150306@37 BUD:
11/30/2015,
20150906@50 BUD:
12/6/2015,
20150906@7 BUD:
12/5/2015,
20151208@32 BUD:
2/8/2016, 20152304@2
BUD: 10/20/2015,
20152804@6
BUD:10/24/2015
Lot Code: 20150604@4
BUD: 10/3/2015,
20152205@1 BUD:
11/18/2015,
20152303@3 BUD:
9/19/2015,
20150604@1 BUD:
10/3/2015,
20151304@27 BUD:
9/19/2015,
20151506@19 BUD:
12/12/2015,
20151506@27R BUD:
11/28/2015,
20151603@2 BUD:
9/12/2015,
20152004@13 BUD:
10/17/2015,
20152206@13 BUD:
12/19/2015,
20152906@7 BUD:
12/26/2015
Lot Code:
20151506@31 BUD:
9/13/2015
Class
Reason for
Recall
Recalling Firm
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
US
Compounding
Inc
46
Product
Type
Product Description
Code Info
Class
Drugs
Phenylephrine 10% PF
Ophthalmic Solution, 3 mL
dropper bottle
Lot Code: 20151803@4
BUD: 9/14/2015,
20152005@19 BUD:
11/16/2015,
20152307@15 BUD:
1/19/2016,
20153003@4 BUD:
9/26/2015
Class II
Drugs
Phenylephrine (1 mg/mL),
5 mL Multi-Dose Vial
Lot Code:
20150904@11 BUD:
10/6/2015
Class II
Phenylephrine PF (1 mg/10
mL), 10 mL Single Use
Syringe
Lot Code: 20150806@1
BUD: 12/5/2015,
20150806@2 BUD:
12/5/2015,
20151105@4 BUD:
11/7/2015,
20151105@6 BUD:
11/7/2015,
20151407@3 BUD:
1/10/2016,
20151603@1 BUD:
9/12/2015,
Class II
Drugs
Reason for
Recall
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
47
Product
Type
Product Description
Code Info
Class
20151805@25 BUD:
11/14/2015,
20151805@28 BUD:
11/14/2015,
20152206@17 BUD:
12/19/2015,
20152707@1 BUD:
1/23/2016,
20153003@1 BUD:
9/26/2015,
20152003@2 BUD:
9/26/2015
Drugs
Phenylephrine PF Sterile
Solution (2.5%), 3 mL Single
Use Ophthalmic Dropper
Lot Code: 20150206@3
BUD: 11/29/2015,
20150306@51 BUD:
11/30/2015,
20151106@28 BUD:
12/8/2015,
20151404@4 BUD:
10/11/2015,
20151606@3 BUD:
12/13/2015
Drugs
Pilocarpine (1/16%)
Ophthalmic, 15 mL dropper
bottle
Lot Code: 20152406@3
BUD: 9/12/2015,
20153108@16 BUD:
11/29/2015
Class II
Drugs
Prednisolone Sodium
Phosphate PF Solution (1%)
in 15 mL dropper bottle
Lot Code:
20150209@16 BUD:
10/2/2015
Class II
Class II
Reason for
Recall
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
48
Product
Type
Product Description
Code Info
Class
Drugs
Succinylcholine Chloride
(200 mg/10 mL), 10 mL
Single Use Syringe (20
mg/mL)
Lot Code: 20152606@4
BUD: 9/23/2015,
20151108@49 BUD:
11/9/2015
Class II
Drugs
Drugs
Testosterone cypionate,
USP (250 mg/mL), 10 mL
Multi-Dose Vial
Testosterone EO-Pro-Cyp
220 (220 mg/mL) 30 mL
Multi-Dose Vial
Lot Code:
20150306@41 BUD:
11/30/2015,
20150505@56 BUD:
11/1/2015,
20150605@21 BUD:
11/2/2015,
20151607@33 BUD:
1/12/2015,
20152104@9 BUD:
10/18/2015,
20152206@24 BUD:
12/19/2015,
20151404@26 BUD:
10/11/2015,
20152104@9 BUD:
10/18/2015
Lot Code:
20151006@46 BUD:
12/7/2015,
20151607@40 BUD:
1/12/2016,
20152005@32 BUD:
11/16/2015,
Reason for
Recall
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Recalling Firm
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
US
Compounding
Inc
49
Product
Type
Product Description
Code Info
Class
20152304@28 BUD:
10/20/2015,
20152304@5 BUD:
10/20/2015,
20152606@2 BUD:
12/22/2015,
20152907@16 BUD:
1/23/2016
Trace Elements-4 (Zinc
Sulfate heptahydrate 4.39
mg, Cupric Sulfate
pentahydrate 1.57 mg,
Manganese Sulfate
monohydrate USP 0.308
mg, Chromic Chloride
hexahydrate USP 0.0205
mg), 10 mL Multi-Dose Vial
Lot Code:
20152804@35 BUD:
10/25/2015,
20150505@26 BUD:
11/1/2015
Class II
Drugs
Triamcinolone acetonide,
Multi-Dose Vial
Lot Code:
20150605@28 BUD:
11/2/2015,
20150607@38 BUD:
1/2/2016, 20150906@3
BUD: 12/6/2015
Class II
Drugs
Triamcinolone/Lidocaine
(40 mg/1%/mL), 10 mL
Multidose Vial
Lot Code:
20150204@18 BUD:
9/29/2015,
20150906@38 BUD:
12/6/2015
Class II
Drugs
Reason for
Recall
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
50
Product
Type
Drugs
Drugs
Product Description
Triamcinolone diacetate
Multi-Dose Vial
Triamcinolone diacetate
USP PF (40 mg/mL), 2 mL
Vial
Code Info
Lot: 20150204@7 BUD:
9/29/2015,
20150304@1 BUD:
9/29/2015,
20150604@23 BUD:
10/3/2015,
20150807@50 BUD:
1/4/2016,
20150906@23 BUD:
12/6/2015,
20150906@24 BUD:
12/6/2015,
20152005@42 BUD:
11/16/2015,
20152206@52 BUD:
12/19/2015,
20152406@14 BUD:
12/21/2015,
20152603@26 BUD:
9/22/2015,
20152804@20 BUD:
10/25/2015,
20152904@20 BUD:
10/26/2015,
20152907@8 BUD:
1/25/2016,
20151603@56 BUD:
9/12/2015,
20152406@30 BUD:
12/21/2015
Lot Code:
20150608@19 BUD:
2/2/2016,
20150807@35 BUD:
1/4/2016,
20152104@12 BUD:
10/1//2015,
20150105@2 BUD:
10/28/2015,
20150605@36 BUD:
11/2/2015,
20150607@26 BUD:
Class
Reason for
Recall
may have an
impact on
sterility
assurance.
Recalling Firm
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
US
Compounding
Inc
51
Product
Type
Drugs
Drugs
Product Description
Tri-Mix 30/1/10
(papaverine HCL USP 30
mg/ phentolamine
mesylate USP 1 mg/
alprostadil USP 10
mcg/mL), 5 mL Multi-Dose
Vial
Tropicamide 0.5%/
Phenylephrine 5%, 2 mL
Dropper Bottle
Code Info
1/2/2016,
20150904@32 BUD:
10/6/2015,
20150906@35 BUD:
12/6/2015,
20151506@45 BUD:
12/12/2015,
20151603@43 BUD:
9/12/2015,
20152204@15 BUD:
10/19/2015,
20152506@35 BUD:
12/22/2015,
20152907@1 BUD:
1/25/2016
Lot Code:
20151305@17 BUD:
9/16/2015,
20151504@18 BUD:
9/16/2015,
20151903@13 BUD:
9/12/2015,
20151903@13 BUD:
9/12/2015,
20152107@3 BUD:
1/16/2016,
20152204@6 BUD:
9/16/2015,
20152403@13 BUD:
9/12/2015,
20152403@21 BUD:
9/16/2015,
20152904@8 BUD:
9/16/2015
Lot Code:
20151606@11 BUD:
12/13/2015
Class
Reason for
Recall
sterility
assurance.
Recalling Firm
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
US
Compounding
Inc
Class II
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
US
Compounding
Inc
52
Product
Type
Product Description
Code Info
Drugs
Tropicamide
1%/Phenylephrine 2.5%
(tropicamide USP 10 mg/
phenylephrine HCL USP 25
mg), 10 mL Ophthalmic
Dropper
Lot Code: 20151307@4
BUD: 1/9/2016,
20151805@30 BUD:
11/14/2015,
20152004@23 BUD:
10/17/2015
Drugs
Vancomycin Ophthalmic PF
0.5 mL (5 mg/0.5 mL (10
mg/mL), 1 mL syringe
Lot Code:
20152306@13 BUD:
12/20/2015
Class II
Drugs
Vitamin D3 in Olive Oil
(50,000 IU/mL) 30 mL vial
Lot Code:
20151703@26 BUD:
9/13/2015,
20151703@26 BUD:
9/13/2015
Class II
Drugs
Voriconazole Solution
Lot Code:
Class II
Class
Class II
Reason for
Recall
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Recalling Firm
US
Compounding
Inc
US
Compounding
Inc
US
Compounding
Inc
US
53
Product
Type
Product Description
Code Info
(1%(10 mg/mL), 15 mL
dropper bottle
20150209@40 BUD:
9/16/2015
Drugs
Zinc Sulfate (1 mg/mL), 10
mL Single Dose Vial
Lot Code: 20150804@1
BUD: 10/5/2015,
20150907@1 BUD:
1/5/2016
Drugs
Acetylcysteine 10% Oph
Solution, packaged in a) 6
mL and b) 12 mL dropper
bottles
Lot #: 2839-081715,
Exp 11/17/2015
Class
Class II
Class II
Reason for
Recall
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility; The
firm is recalling
all sterile
preparations
that are within
expiry due to
deficient
practices which
may have an
impact on
sterility
assurance.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
Recalling Firm
Compounding
Inc
US
Compounding
Inc
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
54
Product
Type
Drugs
Drugs
Drugs
Product Description
Code Info
17-Alpha
Hydroxyprogesterone 250
mg/mL in Castor Oil
Injection, 5 mL vials
Lot #: 062015, Exp
09/20/2015; 062215,
Exp 09/22/2015;
062515, Exp
09/25/2015; and
072115, Exp
10/21/2015
17-Alpha
Hydroxyprogesterone 250
mg/mL in Sesame Oil
Lot #: 060815, Exp
09/08/2015; 062915,
Exp 09/29/2015;
072315, Exp
10/23/2015; and 760081815, Exp
11/18/2015
BIMIX INJ 30 mg-1 mg/mL
Lot #: 071015, Exp
09/10/2015; 072115,
Exp 09/21/2015; and
080715, Exp
10/07/2015
Class
Class II
Class II
Class II
Reason for
Recall
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
55
Product
Type
Drugs
Drugs
Product Description
Cyclosporin 0.1% Opth
Solution, 10 mL dropper
bottles
Dexamethasone 0.4% Opth
Ointment, 3.5 g ointment
tubes
Code Info
Lot #: 062915, Exp
09/29/2015; 070915,
Exp 10/09/2015;
073015, Exp
10/30/2015; 080315,
Exp 11/03/2015; and
080615, Exp
11/06/2015
Lot #: 062515, Exp
09/25/2015; and
070615, Exp
10/06/2015
Class
Class II
Class II
Reason for
Recall
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
Recalling Firm
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
56
Product
Type
Drugs
Drugs
Product Description
Code Info
DUAL TEST CYP/ENA 1:1
200 mg/mL Injection,
packaged in a) 5 mL and b)
100 mL vials
Lot #: 060815, Exp
09/08/2015; 061615,
Exp 09/16/2015;
062915, Exp
09/29/2015; 070615,
Exp 10/06/2015;
071615, Exp
10/16/2015; 073015,
Exp 10/30/2015; and
080615, Exp
11/08/2015
Glycerin Opth Solution, 10
mL dropper bottles
Lot #: 071515, Exp
10/15/2015
Class
Class II
Class II
Reason for
Recall
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
57
Product
Type
Product Description
Code Info
Drugs
HCG 1000 Units/mL SUB-Q
Injection, packaged in a)1.5
mL, b) 2 mL, c) 2.4 mL, d) 4
mL, e) 6 mL, f) 7.5 mL, g) 8
mL, and h) 9 mL vials
Lot #: 080415, Exp
09/04/2015; 080515,
Exp 09/05/2015;
080615, Exp
09/06/2015; 080715,
Exp 09/07/2015;
081015, Exp
09/10/2015; 081115,
Exp 09/11/2015;
081215, Exp
09/12/2015; 081315,
Exp 09/13/2015;
081415, Exp
09/14/2015; 1702081715, Exp
09/17/2015; 1702081815, Exp
09/18/2015; and 1702081915, Exp
09/19/2015
Drugs
Lot #: 080415, Exp
HCG 1000 U/ LIDO 0.2%/mL
09/04/2015; and 4721Injection, packaged in a) 3
081715, Exp
mL and b) 8 mL vials
09/17/2015
Class II
Drugs
HCG 2000 Units/mL
Injection, packaged in a) 4
Class II
Lot #: 080415, Exp
09/04/2015; and
080715, Exp
Class
Class II
Reason for
Recall
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
58
Product
Type
Product Description
Code Info
Class
09/07/2015
Drugs
Drugs
HCG 3000 Units/mL
Injection, 2 mL vial
HCG 5000 Units/mL
Injection, 0.4 mL vials
Lot #: 081015, Exp
09/10/2015
Lot #: 081315, Exp
09/13/2015
Class II
Class II
Reason for
Recall
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
Recalling Firm
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
59
Product
Type
Drugs
Drugs
Product Description
Code Info
HCG 10,000 Units/mL
mL, b) 1.2 mL, c) 1.6 mL, d)
2.0 mL, e) 2.4 mL, f) 3.6 mL,
g) 4 mL, h) 4.8 mL vials; and
i) 0.1 mL, j) 0. 2 mL, k) 0.3
mL prefilled syringes
Lot #: 080615, Exp
09/06/2015; 081215,
Exp 09/12/2015;
081315, Exp
09/13/2015; 081415,
Exp 09/14/2015; 1730081715, Exp
09/17/2015; 1730081815, Exp
09/18/2015; and 1730081915, Exp
09/19/2015
LIPO B Injection, packaged
in a) 2 mL, b) 12 mL, c) 15
mL, or d) 30 mL vials
Lot #: 061215, Exp
09/12/2015; 061915,
Exp 09/19/2015;
070115, Exp
10/01/2015; 072315,
Exp 10/23/2015; and
073115, Exp
10/31/2015
Class
Class II
Class II
Reason for
Recall
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
60
Product
Type
Product Description
Code Info
Class
LIPO-B Special Injection,12
mL vials
Lot #: 073115, Exp
10/31/2015
Drugs
Methylcobalamin 1 mg/mL
(Pres Free) Injection, 1 mL
prefilled syringes
Lot #: 072915, Exp
09/13/2015; 080415,
Exp 09/19/2015; and
1345-081815, Exp
10/03/2015
Class II
Drugs
Methylcobalamin 5000
Lot #: 072715, Exp
Class II
Drugs
Class II
Reason for
Recall
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
61
Product
Type
Drugs
Drugs
Product Description
Code Info
mcg/mL Preservative Free
09/10/2015; and
073015, Exp
09/13/2015
Methylcobalamin 20
mg/mL PF Injection, 0.05
mL prefilled syringes
Methylcobalamin 25
mg/mL PF Injection, 0.5 mL
prefilled syringes
Lot #: 3327-081715,
Exp 09/17/2015
Lot #: 072915, Exp
09/13/2015
Class
Class II
Class II
Reason for
Recall
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
Recalling Firm
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
62
Product
Type
Drugs
Drugs
Product Description
Methylcobalamin 30
mg/mL PF Injection, 0.1 mL
prefilled syringes
MIC Injection, 30 mL vials
Code Info
Lot #: 072815, Exp
09/10/2015
Lot #: 071315, Exp
10/13/2015
Class
Class II
Class II
Reason for
Recall
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
63
Product
Type
Drugs
Drugs
Product Description
Code Info
Progesterone 100 mg/mL
IM* Injection in Sesame
Oil, 10 mL vials
Lot #: 062315, Exp
09/23/2015; 071615,
Exp 10/16/2015; and
080615, Exp
11/06/2015
in Corn Oil Injection, 2 mL
vials
Lot #: 072915, Exp
10/29/2015
Class
Class II
Class II
Reason for
Recall
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
64
Product
Type
Drugs
Product Description
Code Info
Ethyl Oleate Injection, 10
mL vials
Lot #: 072415, Exp
10/24/2015; and
080715, Exp
11/07/2015
Drugs
QUAD MIX (30 mg-1 mg-20
mcg-0.16 mg / mL)
Injection, 5.2 mL vials
Lot #: 071315, Exp
09/13/2015
Drugs
Sermorelin 9 mg/10 mL
SUB-Q* Injection, packaged
in a) 3 mL, b) 5 mL, c) 6 mL,
or d) 9 mL vials
Lot #: 080515, Exp
09/05/2015; 080715,
Exp 09/07/2015;
081115, Exp
09/11/2015; and
Class
Class II
Class II
Class II
Reason for
Recall
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
65
Product
Type
Product Description
Code Info
Class
081415, Exp. Date
09/14/2015
Drugs
Drugs
Sermorelin 1000 mcg/mL
SUB-Q* Injection, packaged
in a) 3 mL, b) 6mL, c) 7.5ml,
d) 9 mL or e) 10 mL vials
sermorelin 1000 mcg/mL /
LIDO 0.2% Injection, 6 mL
vials
Lot #: 080415, Exp
09/04/2015; 080515,
Exp 09/05/2015;
080615, Exp
09/06/2015; 080715,
Exp 09/07/2015;
081015, Exp
09/10/2015; 081115,
Exp 09/11/2015;
081215, Exp
09/12/2015; 081315,
Exp 09/13/2015;
081415, Exp
09/13/2015; 081515,
Exp 09/15/2015; 453081715, Exp
09/17/2015; 453081815, Exp
09/18/2015; and 453081915, Exp
09/19/2015
Lot #: 080415, Exp
09/04/2015
Reason for
Recall
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Recalling Firm
Pharma
Class II
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Class II
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
66
Product
Type
Drugs
Drugs
Product Description
Code Info
Testosterone Cypionate 50
mg/mL Injection, 1 mL vials
Lot #: 081215, Exp
11/12/2015
Testosterone Cypionate
200 mcg/mL in Sesame Oil
Injection, packaged a) 5 mL
and b) 100 mL vials
Lot #: 060815, Exp
09/08/2015; 061615,
Exp 09/16/2015;
070615, Exp
10/06/2015; 071615,
Exp 10/16/2015; and
080615, Exp
11/06/2015
Class
Class II
Class II
Reason for
Recall
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
67
Product
Type
Drugs
Product Description
Code Info
200 mcg/mL in Corn Oil
Lot #: 070115, Exp
10/01/2015; and
071015, Exp
10/10/2015
Class
Class II
Drugs
Testosterone
CYP/ENAN/PROP Injection,
66.6 mg/66.6. mg/66.6
mg/mL, 5 mL vials
Lot #: 062915, Exp
09/29/2015; and
071615, Exp
10/16/2015
Class II
Drugs
Testosterone
CYP/ENAN/PROP Injection
Lot #: 060415, Exp
09/04/2015
Class II
Reason for
Recall
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
68
Product
Type
Product Description
Code Info
Class
in Cottonseed Oil, 66.6
mg/66.6. mg/66.6 mg/mL,
5 mL vials
Drugs
Drugs
TRIMIX #1 Injection, 4.2 mL
vials
Lot #: 071015, Exp
09/10/2015; 071715,
Exp 09/17/2015; and
073015, Exp
09/30/2015
TRIMIX #2 (24 mg-0.8 mg20 mcg /mL) Injection, 5 mL
vials
Lot # 070815, Exp
09/08/2015; 071715,
Exp 09/17/2015;
073115, Exp
10/012015; 080415,
Exp 10/04/2015; and
080615, Exp
10/06/2015
Class II
Class II
Reason for
Recall
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
Recalling Firm
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
69
Product
Type
Drugs
Drugs
Product Description
Code Info
TRIMIX #3 (24 mg-1 mg-20
mcg/mL) Injection, 5 mL
vials
Lot #: 070915, Exp
09/09/2015; and
080315, Exp
10/03/2015
TRIMIX #4 (27 mg-1.5 mg50 mcg/mL) Injection, 5 mL
vials
Lot #: 070715, Exp
09/07/2015
Class
Class II
Class II
Reason for
Recall
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
70
Product
Type
Drugs
Product Description
TRIMIX SPECIAL (30 mg-1
mg-10 mcg/mL) Injection, 5
mL vials
Code Info
Lot #: 073115, Exp
10/01/2015
Class
Class II
Drugs
HYDROCHLOROTHIAZIDE
CAPSULES, USP, 12.5 mg,
3000 count bottles,
T084M14A, T085M14A,
T086M14A; Exp 12/16
Class II
Drugs
L-Glutamine Injectable,
30mg/mL, 30mL vial
All lots
Class II
Drugs
L-Tyrosine Injectable,
25mg/mL, 30mL vial
All lots
Class II
Drugs
L-Tryptophan Injectable,
30mg/mL, 30mL vial
All lots
Class II
Drugs
EDTA Disodium Injectable,
150mg/mL, 100mL vial
All lots
Class II
Drugs
Acetyl-L-Carnitine
All lots
Class II
Reason for
Recall
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Lack of
Assurance of
Sterility: A
recall of all
compounded
sterile
preparations
within expiry is
being initiated
due to
observations
associated with
poor sterile
production
practices
resulting in a
lack of sterility
assurance for
their finished
drugs.
Presence of
Particulate
Matter.
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Recalling Firm
Kalman Health
& Wellness,
Inc. dba
Essential
Wellness
Pharma
Vintage
Pharmaceutical
s LLC, DBA
Qualitest
Pharmaceutical
s
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
71
Product
Type
Drugs
Drugs
Drugs
Drugs
Product Description
Injectable, 100mg/mL,
30mL vial, L-Carnitine
Injection 500mg/mL, 30mL
vial
Ascorbic Acid Injectable
500mg/mL, packaged in a)
10mL vials, b) 50mL vials,
c)100mL vials
MICML TRNDPPC Injection
(Preserved) 10mL vial
Riboflavin-5-Phosphate
Injectable,10mg/mL, 10mL
vial
Procaine Injectables
20mg/mL and 2%, 50mL
vial
Code Info
All lots
Class
Class II
All lots
Class II
All lots
Class II
All lots
Class II
Drugs
Co-Enzyme Q-10 Injectable,
20mg/mL, 10mL vial
All lots
Class II
Drugs
Vitamin D3 Injectable,
10,000 U/mL, 10mL vial
All lots
Class II
Drugs
Methylcobalamin Buffered
Injectable, 1mg/mL,
packaged in a) 10mL vial, b)
30mL vial
All lots
Class II
Drugs
Taurine Injectable,
50mg/mL, 30mL vial
All lots
Class II
Drugs
Magnesium Sulfate 50%
Injectable, 50mL vial
All lots
Class II
All lots
Class II
All lots
Class II
All lots
Class II
Drugs
Drugs
Drugs
Cyanocobalamin Buffered
Injectable 3mg/mL, 30mL
vial
Glucosamine HCL
30mL vial
Phosphatidylcholine/Deoxy
cholic Acid Injection
(Preserved) 50 ML
10/4.75%;
Reason for
Recall
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Recalling Firm
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
72
Product
Type
Drugs
Drugs
Product Description
(Preserved) 50 ML 5/2.5%;
(Preserved) 50 ML 5/4.2%
Methylcobalamin Buffered
Injectable, 5mg/mL, 30mL
vial
HCG (Lyophilized)
Injectable, 5000 units/vial,
5mL vial
Code Info
Class
All lots
Class II
All lots
Class II
Drugs
Chromium Injectable,
200mg/mL, 30mL vial
All lots
Class II
Drugs
EDTA Calcium Disodium
50mL vial
All lots
Class II
Drugs
TNPRDC Injection, 6 mL vial
All lots
Class II
Drugs
DMPS Injectable, 50mg/mL,
All lots
5mL vial
Class II
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Magnesium Sulfate
Injectable, 14.28%, 7mL
vial
Green Tea (EGCG)
Injectable, 10mg/mL,10mL
vial
TNPDR Injection Buffered,
30mL vial
Calcium Gluconate
(680mOsm/L) Injection
10%, 50mL vial
Sermorelin/GHRP-6/GHRP2 Injection
3MG/3MG/3MG, 5mL vial
Hydroxocobalamin
Injection (Buffered)
1mg/mL, 30mL vial
All lots
Class II
All lots
Class II
All lots
Class II
All lots
Class II
All lots
Class II
All lots
Class II
Drugs
B12 Injection 12.5/12.5MG,
3mL
All lots
Class II
Drugs
Magnesium Chloride
Hexahydrate Injection
All lots
Class II
Reason for
Recall
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Recalling Firm
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
73
Product
Type
Product Description
Code Info
Class
200mg/mL, 50mL vial
Drugs
L-Arginine Injection,
100mg/mL, 30mL vial
All lots
Class II
Drugs
DMSO 99% Injection, 50mL
vial
All lots
Class II
Drugs
L-Glutathione Injection,
200mg/mL, 50mL vial
All lots
Class II
Drugs
Folic Acid Injection,
10mg/mL, 30mL vial
All lots
Class II
Drugs
Piracetam Injection,
200mg/mL,10mL vial
All lots
Class II
Drugs
Pyridoxine Injection, 100
mg/mL, 30mL vial
All lots
Class II
Drugs
DMAE
Dimethylaminoethanol
Injection, 100mg/mL, 30mL
vial
Drugs
Dexpanthenol Injection,
250mg/mL, 30mL vial
All lots
Class II
Drugs
M.I.C Injection (Preserved),
25/50/25mg/mL, 50mL vial
All lots
Class II
Drugs
Zinc Sulfate (Elemental)
Injection, 10mg/mL, 30 mL
vial
All lots
Class II
Drugs
Thiamine HCl Injection,
100mg/mL, 30mL vial
All lots
Class II
All lots
Class II
All lots
Class II
All lots
Class II
All lots
Class II
Drugs
Drugs
Drugs
Drugs
Injection (Sesame Oil),
200mg/mL, 10mL vial
Potassium Chloride
Injection (20mEq/10mL),
2mEq/ML, 10mL vial
Magnesium Sulfate
Injection (4060mOsm/L),
50%, 50mL vial
Thiotic Acid Injection,
All lots
Class II
Reason for
Recall
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Recalling Firm
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
LLC
Downing Labs,
74
Product
Type
Product Description
Code Info
Class
25mg/mL, 30mL vial
Drugs
MIC w/Methyl B-12
Preserved Injection,
25/50/50/1mg/mL, 50mL
vial
Drugs
c-Budesonide 0.6MG
capsules, 60-count bottle
Drugs
Estradiol USP 99.5%, .5%
Stearic Acid NF Pellets, 3
mL, one-count vials, 6 mg
(NDC 69761-006-01),10 mg
(NDC 69761-010-01),12.5
mg (NDC 69761-012-01),
15 mg (NDC 69761-01501),18 mg (NDC 69761018-01),20 mg (NDC
69761-020-01), 22 mg
(NDC 69761-022-01), 25
mg (NDC 69761-025-01)
Drugs
Testosterone USP 99.5%,
.5% Stearic Acid NF Pellets,
3 mL, one-count vials, 25
mg (NDC 69761-125-01),
37.5 mg (NDC 69761-13701), 50 mg (NDC 69761-
All lots
Lot #: 04-24-2015-D,
Exp 05/31/15; 03-132015-C, 03-18-2015-F,
03-18-2015-G, 03-232015-C, 03-24-2015-C,
04-02-2015-G, 04-142015-F, 04-14-2015-G,
04-22-2015, 05-062015-B, 05-14-2015-D,
05-22-2015-F, 05-272015-C, 06-02-2015-E,
06-10-2015-J, Exp
06/16/15
Lots: A002 Exp.:
10/23/2015; A003 Exp.:
10/25/2015; A009 Exp.:
11/01/2015; A011 Exp.:
11/2/2015; A014 Exp.:
11/8/2015; A016 Exp.:
11/10/2015; A027 Exp.:
11/20/2015; A028 Exp.:
11/21/2015; A030 Exp.:
11/22/2015; A032 Exp.:
11/23/2015; A037 Exp.:
11/24/2015; A039 Exp.:
11/27/2015; A042 Exp.:
11/28/2015; A044 Exp.:
11/29/2015; A050 Exp.:
12/06/2015; A051 Exp.:
12/10/2015; A053 Exp.:
12/12/2015; A062 Exp.:
12/20/2015; A065 Exp.:
12/28/2015
Lots: A005 Ex.:
10/30/2015; A008 Ex.:
11/01/2015; A010 Ex.:
11/06/2015; A012 Ex.:
11/07/2015; A015 Ex.:
11/08/2015; A018 Ex.:
Reason for
Recall
Assurance of
Sterility
Recalling Firm
LLC
Class II
Lack of
Assurance of
Sterility
Downing Labs,
LLC
Class II
Penicillin Cross
Contamination
- Possible
presence of
penicillin in
bulk
budesonide
powder used to
compound
prescription
nasal
rinse/nebulizer
capsules.
Solutions
Class II
Lack of
Assurance of
Sterility: The
firm is recalling
all sterile
preparations
within expiry
due to deficient
practices which
may have an
impact on
sterility
assurance.
Qualgen
Class II
Lack of
Assurance of
Sterility: The
firm is recalling
all sterile
preparations
Qualgen
75
Product
Type
Product Description
Code Info
150-01), 87.5 mg (NDC:
69761-187-01), 100 mg
(NDC 69761-110-01), 200
mg (NDC 69761-120-01)
11/13/2015; A022 Ex.:
11/14/2015; A024 Ex.:
11/16/2015; A026 Ex.:
11/20/2015; A029 Ex.:
11/21/2015; A033 Ex.:
11/23/2015; A038 Ex.:
11/24/2015; A040 Ex.:
11/27/2015; A041 Ex.:
11/28/2015; A045 Ex.:
12/03/2015; A046 Ex.:
11/30/2015; A047 Ex.:
12/04/2015; A052 Ex.:
12/12/2015; A055 Ex.:
12/13/2015; A058 Ex.:
12/18/2015; A059 Ex.:
12/19/2015; A061 Ex.:
12/24/2015
Class
Drugs
2-DEOXY-D-GLUCOSE
Powder
all lots
Class II
Drugs
E3 CREAM
Lot: 02-11-15 14:44 Y,
Exp Date: 08/10/15
Class II
Drugs
HYDROXOCOBALAMIN
Injection
all lot numbers, all
expiration dates
Class II
Drugs
ESTRIOL Capsules
All lots
Class II
Drugs
ESTRIOL Vaginal Creams
All lots
Class II
Drugs
ESTRIOL Suppositories
All lots
Class II
Reason for
Recall
within expiry
due to deficient
practices which
may have an
impact on
sterility
assurance.
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
Recalling Firm
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
76
Product
Type
Product Description
Code Info
Class
Drugs
ESTRIOL Vaginal Gels
All lots
Class II
Drugs
ESTRIOL Face Creams
All lots
Class II
Drugs
ESTRIOL Creams
All lots
Class II
Drugs
ESTRIOL Gels
All lots
Class II
Drugs
BI-EST Capsules
All lots
Class II
Drugs
BI-EST Gels
All lots
Class II
Drugs
BI-EST Lozenges
All lots
Class II
Drugs
BI-EST Suspensions
All lots
Class II
Drugs
BI-EST Creams
All lots
Class II
Reason for
Recall
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
Recalling Firm
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
77
Product
Type
Product Description
Code Info
Class
Drugs
TRI-EST Capsules
All lots
Class II
Drugs
TRI-EST Lozenges
All lots
Class II
Drugs
TRI-EST Liquids
All lots
Class II
Drugs
TRI-EST Gels
All lots
Class II
Drugs
METHYLFOLATE Capsules
All lots
Class II
Drugs
METHYLFOLATE Injection
All lots
Class II
Drugs
HUMAN CHORIONIC
GONADOTROPIC (HCG)
Injection
All lots
Class II
Drugs
HUMAN CHORIONIC
GONADOTROPIC (HCG)
Sublingual Drops
All lots
Class II
Drugs
Asthmanefrin
Racepinephrine Inhalation
Solution Bronchodilator,
Lots R4027A (Exp
10/31/2015), R4036A
(Exp 12/31/2015)
Class II
Reason for
Recall
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Penicillin Cross
Contamination:
potentially
contaminated
with penicillin
Discoloration
Recalling Firm
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Life Science
Pharmacy Inc
Nephron
Pharmaceutical
s Corp.
78
Product
Type
Drugs
Product Description
Starter Kit (Racepinephrine
11.25 mg) 10 individual foil
wrapped vials with 1 EZ
Breathe Atomizer per
carton,
Asthmanefrin
Racepinephrine Inhalation
Solution Bronchodilator
Refills (Racepinephrine USP
11.25 mg), 30 individual foil
wrapped vials per carton
Code Info
Class
Reason for
Recall
Recalling Firm
Lots R4016A (Exp
08/31/2015), R4017A
(Exp 08/31/2015),
R4035A (Exp
12/31/2015)
Class II
Discoloration
Nephron
Pharmaceutical
s Corp.
Drugs
Carbo-O-Philic 40 Cream
40% (Urea) tubes, a) 3 oz
(85 g)
Lot #: a)1502156,
1507104 b)1503039,
1507001
Class II
Drugs
Carbo-O-Philic 40 Gel 40%
(Urea) NET WT tube, .5 oz
(15 g)
Lot # 1502078,
1504139
Class II
GRx HiCort 25
(hydrocortisone acetate 25
mg) Suppositories, 12count box
Lot #: 1310001, 13J04,
1310167, 1311013,
1312008, 1401055,
13S02, 14A05,
1402061, 14C01,
14C05, 14C06, 14E02,
1405081, 1406107,
1407062, 14096751,
14096752, 14096753,
15026752, 15026752,
15046752, 15066752,
15066753
Drugs
Class II
Marketed
without an
Approved
NDA/ANDA:
FDA has
determined
that the
products are
unapproved
new drugs and
misbranded.
Marketed
without an
Approved
NDA/ANDA:
FDA has
determined
that the
products are
unapproved
new drugs and
misbranded.
Marketed
without an
Approved
NDA/ANDA:
FDA has
determined
that the
products are
unapproved
new drugs and
misbranded.
Geritrex Corp
Geritrex Corp
Geritrex Corp
79
Product
Type
Product Description
Code Info
Class
Drugs
Polyethylene Glycol 3350GRX Powder 100% jars a)
8.4 oz (250 g) (NDC 54162335-02), b) Net wt. 16.9 oz
(500 g) (NDC 54162-33505),
Lot #: a) 1201092,
1403053, 1210028,
1007059, 1112105,
1305044, 1303079,
1406098, 1407061,
1505037, 1412004
1408081, b) 1112105 &
1007036
Class II
Drugs
Prostin Injection 10
mcg/mL, 25 mcg/mL, 50
mcg/mL
all lots
Class II
Drugs
Ace-Promazine 10 mg/mL
Injection
all lots
Class II
Drugs
AMP50/B121MG Complex
Mix/ML Injection
all lots
Class II
Drugs
B-12 1000/B6 1000
mcg/mL Injection
all lots
Class II
Drugs
Bladder Mixture Prep
all lots
Class II
Drugs
Boric Acid 1% Ear Drop
all lots
Class II
Drugs
Butor/Nal/Hydro Nasal
Susp
all lots
Class II
Drugs
Cyclosporine 1% Opth Sol
all lots
Class II
Drugs
Dep-Estradiol 10 mg/mL
Injection
all lots
Class II
Drugs
Depo-Testadiol 10/5mg/mL
Injection
all lots
Class II
Drugs
Folic Acid Injection 5
mg/mL,10 mg/mL
all lots
Class II
Drugs
Furosemide 20 mg/mL svn
all lots
Class II
Reason for
Recall
Marketed
without an
Approved
NDA/ANDA:
FDA has
determined
that the
products are
unapproved
new drugs and
misbranded.
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Recalling Firm
Geritrex Corp
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
80
Product
Type
Product Description
Code Info
Class
Sol
Drugs
Gent 80 mg/Liter Nasal
all lots
Class II
Drugs
Glutathione 200 mg/mL
SVN Injection
all lots
Class II
Drugs
Glutathione 300 mg/1.5 mL
Injection,
all lots
Class II
Drugs
Hydroxocobalamin 1mg/mL
Injection,
all lots
Class II
Drugs
Hydroxocobalamin
5000IU/mL Injection,
all lots
Class II
Drugs
M-Cobalamin (B12)
Injection 200 mcg,
2000mcg,
all lots
Class II
Drugs
M-Cobalamin 2/Folate
5mg/mL Injection
all lots
Class II
Drugs
Medroxyprogesterone
150/LID 5 mg/mL Injection
all lots
Class II
all lots
Class II
all lots
Class II
Drugs
Drugs
Methylcobalamin Injection
1000 mcg/mL, 10000
mcg/mL
Methylcobalamin Injection
10 mg/mL, 20 mg/mL, 30
mg/mL
Drugs
Mupiro/Doxycyc Sinus
Rinse
all lots
Class II
Drugs
Alcohol4%/Bupivicaine0.5%
all lots
sol
Class II
Drugs
Ascorbic Acid 500 mg/mL
Injection
all lots
Class II
Drugs
Cantharitus Multi-Mix Prep
all lots
Class II
Drugs
Benadryl 50mg/2mL Pres-
all lots
Class II
Reason for
Recall
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Recalling Firm
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
81
Product
Type
Product Description
Code Info
Class
Free Injection
Drugs
Calcium Chloride Dihydrate
Injection
all lots
Class II
Drugs
Calcium EDTA 300mg/mL
Injection
all lots
Class II
Drugs
Calcium Gluconate 10%
Injection
all lots
Class II
Drugs
Cantharidin 0.7% Sol
all lots
Class II
Drugs
Cyancobalamin
2000mcg/mL Injection
all lots
Class II
Drugs
Dexpanthanol B5
250mg/mL Injection
all lots
Class II
Drugs
Dextrose 50% Inj Sol
all lots
Class II
Drugs
HCG 10,000U/10mL
Injection
all lots
Class II
Drugs
Heparin 1000 Unit/mL
Injection
all lots
Class II
Drugs
Heparin Sodium
30,000U/30ML Injection
all lots
Class II
Drugs
Hydrochloric Acid 2mg
Injection
all lots
Class II
Drugs
Jessners Dermal Solution
all lots
Class II
Drugs
Ketorolac 40mg/mL
Injection
all lots
Class II
Drugs
Lidocaine Injection 1% , 2%
all lots
Class II
Drugs
Magnesium Chloride
all lots
Class II
Reason for
Recall
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Recalling Firm
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
82
Product
Type
Product Description
Code Info
Class
Injection
Drugs
Magnesium Sulfate 50%
Injection
all lots
Class II
Drugs
Marcaine 0.24%/Ethanol
4% Injection
all lots
Class II
Drugs
N.A.C. 20% SVN Sol
all lots
Class II
Drugs
Novarel "HCG" 10000U/Vial all lots
Class II
Drugs
Omnitrope 17.4U/10mL InjKit
all lots
Class II
Drugs
Phenylephrine 500mcg/mL
Injection
all lots
Class II
Drugs
Podophyllum 40% Topical
all lots
Class II
Drugs
Potassium Chloride 40
mEq/mL Inj
all lots
Class II
Drugs
Procaine HCl Injection 1%,
2%
all lots
Class II
Drugs
Progesterone Cyp Inj
all lots
Class II
Drugs
Pyridoxine B6 100mg Inj
all lots
Class II
Drugs
PZI 40 Insulin (Human) Inj
all lots
Class II
Drugs
Quad Mix Inj, Rx
all lots
Class II
Drugs
Sal-Acid 60% Plaster Paste
all lots
Class II
Drugs
Sermorelin Injection
all lots
Class II
Reason for
Recall
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Recalling Firm
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
83
Product
Type
Product Description
Code Info
Class
10mg/10mL,10mg/mL,
20mg/10mL, 9mg/9mL, Rx
Drugs
Serum Tears 20% Opth
all lots
Class II
Drugs
Sodium Bicarbonate 8.4%
Inj
all lots
Class II
Drugs
Squaric Acid 4% Inj
all lots
Class II
Drugs
Super B Comp w/Cyano 3X
Inj
all lots
Class II
Drugs
T.C.A 30% Acid Sol
all lots
Class II
Drugs
Tacrolimus 0.02% Opth Sol
all lots
Class II
Drugs
Test Cyp/Test Prop 1:1
Injection 100mg/mL,
120mg/mL, 150mg/mL,
160mg/mL, 170mg/mL,
200mg/mL, 300mg/mL
all lots
Class II
Drugs
Testost CYP 200mg/mL SUS
all lots
Class II
Drugs
Testosterone Injection
100mg/mL, 200mg/mL,
300mg/mL
all lots
Class II
Drugs
Tev-Tropin (Somatropin)
Injection
all lots
Class II
Drugs
Toradol 60mg/mL Injection
all lots
Class II
Drugs
Testosterone CYP Inj 200
mg/mL
all lots
Class II
Drugs
Tri-Amino OAC 1:1:1
300mg/mL
all lots
Class II
Drugs
Tri-Mix ED Injection
all lots
Class II
Reason for
Recall
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Recalling Firm
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
84
Product
Type
Product Description
Code Info
Class
Drugs
Tri-Test 1:1:1 300mg/mL
Injection
all lots
Class II
Drugs
Verapamil 120mg/12mL
Injection
all lots
Class II
Drugs
Vitamin B12 (Cyan) Inj
100mcg/mL, 1000mcg/mL
all lots
Class II
Drugs
Vitamin B-Complex 100
Injection
all lots
Class II
Drugs
VitB12/VitC/VitB3/VitB9 Inj
all lots
Class II
Drugs
Wilson's Nasal Irrigation
Solution, Rx
all lots
Class II
Drugs
Hydroxocobalamin 1mg
Injection, Rx
all lots
Class II
Drugs
17-Hydroxyprogesterone
250mg/mL Injection
all lots
Class II
Drugs
Sodium Chloride 0.9% Inj
all lots
Class II
Drugs
Sodium Hydroxide 10% Inj
all lots
Class II
Drugs
HCG 1000unit/10mL MTU
vial
all lots
Class II
Drugs
Lipodissolve 100/50mg Inj
Sol
all lots
Class II
Drugs
Super B Complex 3X Inj
all lots
Class II
Drugs
Super B Complex w/Cyano
Inj
all lots
Class II
Drugs
Tacrolimus 0.03% Opth
Oint
all lots
Class II
Reason for
Recall
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Recalling Firm
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
85
Product
Type
Product Description
Code Info
Class
Drugs
Triamcin 40mg/mL Susp
all lots
Class II
Drugs
Triamcin40/Lido5 mg/mL
Sus
all lots
Class II
Drugs
Tri-Mix LOW ED Injection
all lots
Class II
Drugs
Quad Mix Strong Inj
all lots
Class II
Drugs
Salicylic Acid Inj
all lots
Class II
Drugs
Kindest Kare Antimicrobial
Foaming Handwash, Hand
Soap, 0.75% Triclosan, 444
ml (15 fl oz) bottles
Lot # 277120, Exp
06/01/17
Class II
Drugs
Humulin 70/30, 100
Units/mL Inj, Qty: 10 mL
Vial
LOT # B0080702042715, B0080695042715, B0097444082015, Exp 07/2017;
B0097443-082015, Exp
02/2018.
Class II
Drugs
Bicillin L-A 600000
Units/mL Inj., Qty: 20 mL
Syringe
Lot # B0077329040215, Exp 07/2017;
B0091342-070315, Exp
08/2017; B0109416-
Class II
Reason for
Recall
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Labeling: Not
Elsewhere
Classified;
Incorrect/Unde
clared
Excipients:
Outdated
previous
version of label
applied to
products that
incorrectly
states one
inactive
ingredient.
Labeling:
Incorrect
Instructions;
RemedyRepack,
Inc. a relabeler,
is recalling
these products
due to incorrect
storage
instructions.
Labeling:
Incorrect
Instructions;
RemedyRepack,
Recalling Firm
Western Drug
Western Drug
Western Drug
Western Drug
Western Drug
Steris Corp
RemedyRepack
Inc.
RemedyRepack
Inc.
86
Product
Type
Product Description
Code Info
Class
102815, Exp 03/2018
Drugs
Vitamin B-Complex 100,
Multi MG Inj, Qty: 30 mL
Vial, MFG by: Mylan
Lot # B0105037100715, Exp
10/01/2016
Class II
Drugs
Ascorbic Acid 500 MG/ML
Inj., Qty: 50 mL Vial, MFG
by: Mylan
LOT # B0105052100715, Exp
07/01/2017
Class II
Lorazepam 2 mg/mL Inj.,
Qty: 1 mL Vial, MFG by:
West-Ward
LOT#: B0085124051915, B0086919052815, Exp
12/01/2016; B0089280061215, B0090023061915, B0089996061915, B0091581070715, B0091564070715, B0091515070715, Exp
01/01/2017; B0094980080415, B0094965080415, B0097515082415, B0100639091415, B0100611091415, Exp
03/01/2017; B0100933091515, B0107165101915, B0107118101915, Exp
Drugs
Class II
Reason for
Recall
Inc. a relabeler,
is recalling
these products
due to incorrect
storage
instructions.
Labeling:
Incorrect
Instructions;
RemedyRepack,
Inc. a relabeler,
is recalling
these products
due to incorrect
storage
instructions.
Labeling:
Incorrect
Instructions;
RemedyRepack,
Inc. a relabeler,
is recalling
these products
due to incorrect
storage
instructions.
Recalling Firm
RemedyRepack
Inc.
RemedyRepack
Inc.
Labeling:
Incorrect
Instructions;
RemedyRepack,
Inc. a relabeler, RemedyRepack
is recalling
Inc.
these products
due to incorrect
storage
instructions.
87
Product
Type
Product Description
Code Info
Class
Reason for
Recall
Recalling Firm
06/01/2017.
Drugs
Novolin 70/30, 100
Units/mL Solu., Qty: 1 Vial
LOT#:QM114CZF0496,
Exp 01/2016;
B0025373-050514,
B0029738-060914, Exp
02/2016; B0029737060914, Exp 03/2016.
Drugs
Rocuronium Bromide 50
MG/5ML INJ., Qty: 5 mL
Vial, MFG by: Mylan
Lot#: B0073852030915, Exp 04/2016
Class II
Drugs
Ventolin HFA (albuterol
sulfate) Inhalation Aerosol,
90 mcg per actuation, 200
Metered Inhalations
Lot #s: 5ZP1708, Exp.
12/2016; 5ZP1951, Exp.
02/2017
Class II
Drugs
Pedi MVI a) 5 mL, b) 10 mL
syringe
All lots within expiry.
Class II
Drugs
Heparin injection,
Preservative Free, a) 280
units/0.28 mL, b) 350
units/0.35 mL syringe, c)
440 units/0.44 mL, d) 500
units/0.5 mL syringe, e)
Heparin 800 units/0.8 f)
Heparin 2300 units/2.3 mL
syringe
Class II
Class II
Labeling:
Incorrect
Instructions;
RemedyRepack,
Inc. a relabeler,
is recalling
these products
due to incorrect
storage
instructions.
Labeling:
Incorrect
Instructions;
RemedyRepack,
Inc. a relabeler,
is recalling
these products
due to incorrect
storage
instructions.
Defective
Delivery
System: Some
canisters may
not contain
sufficient
propellant to
deliver the
labeled claim of
200 actuations
through the
end of shelf life.
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
RemedyRepack
Inc.
RemedyRepack
Inc.
GlaxoSmithKlin
e, LLC
Walgreens
Infusion
Services
Walgreens
Infusion
Services
88
Product
Type
Drugs
Drugs
Product Description
Vancomycin Injection in
NS, Accuflo bag, a) 500
mg/NS 100 mL, b)1G/NS
100 mL, c) Vancomycin
1G/NS 250 mL, d) 1.5G/NS
250 mL e) 750 mg/NS 100
mL
Piperacillin/Tazobactam
(Zosyn) Accuflo bag, a) 18
g/NS 275 mL b) 4.5 g/NS
100 mL Accuflo
Code Info
Class
Reason for
Recall
Recalling Firm
Class II
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Class II
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Drugs
Invanz 1 g/NS 100 mL
Minibag Plus
Class II
Drugs
L-Cysteine 800 mg (16 mL)
syringe
Class II
Drugs
Drugs
Drugs
Primaxin (ImipenemCilastatin) 500 mg/NS 100
mL Minibag Plus
Cefazolin in Accuflo bags, a)
1g/NS 25 mL, b) 2g/NS 25
mL, c) 8g/NS 275 mL
Dextrose 5% and 0.45%
Sodium Chloride with KCl
20 mEq 1000 mL
Class II
Class II
Class II
Drugs
0.9% NaCl 1000 mL with Ca
4.65 meq bag
Class II
Drugs
Meropenem 1 g/NS 100 mL
Minibag Plus
Class II
Drugs
Oxacillin 12 g/NS 270 mL24 hr Accuflo bag
Class II
Drugs
Milrinone 0.375
mcg/kg/min D5W bag a)
365 mL, b) 400 mL c) 430
mL
Drugs
Ceftriaxone 2g/NS 100 mL
Minibag Plus
Class II
Drugs
IVIG Gamunex 40 gm (400
mL) Bag
Class II
Class II
89
Product
Type
Product Description
Code Info
Class
Drugs
Phytonadione (Vitamin K) 1
mg/0.1mL Syringe
Class II
Drugs
Thiamine 100 mg (1 mL)
syringe
Class II
Drugs
Folic Acid 1 mg/0.2 mL
syringe
Class II
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Sodium Ascorbate (Vitamin
C) syringe, a) 500 mg/1 mL
syringe, b)1000 mg/2 mL c)
800 mg/1.6 mL
Insulin Regular (Human)
syringe, a)15 unit/0.15 mL,
b) 24 unit/0.24mL syringe,
c) 50 unit/0.5 mL
Famotidine injection
syringe a) 10 mg/1 mL b)
80 mg/8 mL
IVIG Gammagard injection
bag, a) 13 gm, b) 20 gm, c)
73 gm
Teflaro 600 mg in 100 mL
NS Minibag Plus
Gentamicin 14.4
mg/sodium chloride 0.9%
30 mL Prefilled syringe, Rx
Only
Clindamycin injection,
Accuflo bag, a) 500 mg/NS
50 mL b) 900 mg/NS 100
mL
Reason for
Recall
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Recalling Firm
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Class II
Lack of
Assurance of
Sterility
Class II
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Class II
Class II
Class II
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Class II
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Class II
Lack of
Assurance of
Sterility
Walgreens
Infusion
Services
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Drugs
Nafcillin 12 gm in NS 500
mL bag
Class II
Drugs
Remicade (Infliximab)
injection, 5 mg/kg bag
Class II
Drugs
Tobramycin 620 mg/NS 100
mL Accuflo
Class II
Drugs
Cefepime 1 g/NS 100 mL
Minibag Plus
Class II
Walgreens
Infusion
Services
90
Product
Type
Drugs
Drugs
Product Description
Dextrose 5% and 0.9%
Sodium Chloride injection
bag a) 1000 mL, b) 3000 mL
0.9% Sodium Chloride
injection bag, a) 500 mL,
b)1000 mL c)2000 mL Bag
Code Info
Class
Class II
Class II
Drugs
0.9% Sodium Chloride/MVI
injection 2000 mL Bag
Class II
Drugs
3-in-1 TPN formula
daily+overfill Bag, 2000 mL
Class II
Drugs
Clonidine Hydrochloride
Tablets, USP, 0.1 mg, 100count bottles
Lot# B14D26, Exp
02/16
Class II
Reason for
Recall
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
Lack of
Assurance of
Sterility
cGMP
Deviations
Recalling Firm
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
Walgreens
Infusion
Services
PD-Rx
Pharmaceutical
s, Inc.
CLASS III
Drugs
RIFAMPIN FOR INJECTION
USP, 600 mg*/vial
Lot #: 14RIF1(A), Expiry:
9/30/2016.
Class III
Drugs
Hydrocortisone and Acetic
Acid Otic Solution, USP,
containing hydrocortisone
(1%) and acetic acid (2%),
10 mL bottles
Lot # 346191, Exp.
12/2016
Class III
Failed
Impurity/Degra
dation
Specifications:
Out of
Specifications
result obtained
for a known
impurity.
Defective
Container:
Product missing
safety seal
around the
neck of the
bottle. The
product label
indicates,
"Tamper
Evident: Do not
use if printed
seal around cap
is broken or
missing."
Because the
product is
missing the
approved
Akorn, Inc.
Akorn, Inc.
91
Product
Type
Drugs
Drugs
Product Description
Meclizine Hydrochloride
Tablets, USP, 12.5 mg
Tablets, Packaged in a) 100
Ct Bottles (NDC: 49884034-01) and b) 1000 Ct
Bottles
Tablets USP, 25 mg Tablets,
Packaged in a) 100 Ct
Bottles
Code Info
a) Lot #: 24820001,
Expiry: NOV 2015; Lot
#: 25783601, Expiry:
OCT 2016; Lot #:
25783801, Expiry: OCT
2016; Lot #: 26731201,
Expiry: AUG 2017; Lot
#: 26762002, Expiry:
FEB 2018. b) Lot #:
26683201, Expiry: AUG
2017; Lot#: 26762001,
Expiry: FEB 2018.
a) Lot #: 25552101,
Expiry: AUG 2016; Lot#:
25712701, Expiry: SEP
2016; Lot #: 25787902,
#: 26074601, Expiry:
JAN 2017; Lot #:
26259801, Expiry: APR
2017; Lot #: 26220001,
Expiry: MAR 2017; Lot
#: 26579001, Expiry:
JUN 2017; Lot #:
26731801, Expiry: NOV
2017. b) Lot #:
24502301, Expiry: OCT
2015; Lot #: 24505901,
Expiry: OCT 2015; Lot #:
25787901, Expiry: NOV
2016; Lot #: 26074701,
Expiry: JAN 2017; Lot #:
26259701, Expiry: MAR
2017; Lot #: 26575801,
Expiry: JUN 2017; Lot #:
26579002, Expiry: JUN
2017; Lot #: 26682801,
Expiry: SEP 2017; Lot #:
26682901, Expiry: SEP
2017; Lot #: 26731702,
Class
Reason for
Recall
component and
is not
consistent with
the labeling,
the lot is being
recalled.
Recalling Firm
Class III
Failed
Impurities/Degr
adation
Par
Specifications:
Pharmaceutical
Out of
Inc.
specification for
impurities.
Class III
Failed
Impurities/Degr
adation
Par
Specifications:
Pharmaceutical
Out of
Inc.
specification for
impurities.
92
Product
Type
Product Description
Code Info
Class
Reason for
Recall
Recalling Firm
#: 25960301, Expiry:
NOV 2017; Lot #:
26764801, Expiry: MAR
2018.
Failed
Impurities/Degr
adation
Specifications:
Out of
specification for
impurities.
Labeling: Not
elsewhere
classified. NDC
number is
incorrect on the
container.
Drugs
Tablets, USP, 25 mg
Tablets, Packaged in 10 x
10 Tablet Blister Pack
Packages
Lot #: 3060153, Expiry:
08/31/16
Class III
Drugs
Prednisone 20 mg, Tablet,
10-count bottle
Lot # NW 46400021,
Exp 03/2018
Class III
Drugs
Norpace CR (disopyramide
phosphate) extendedrelease capsules USP,150
mg, packaged in a) 100count bottles and b) 500count bottles
Lot #: C150065;
C150064, Exp 6/16
Class III
Failed
Dissolution
Specification
Class III
Failed
Impurities/Degr
adation
Golden State
Specifications:
Medical Supply
Out of
Inc.
specification for
impurities.
Class III
Failed
Impurities/Degr
adation
Golden State
Specifications:
Medical Supply
Out of
Inc.
specification for
impurities.
Drugs
MECLIZINE
HYDROCHLORIDE TABLETS,
12.5 mg, Packaged in 1000
ct Bottles
Drugs
MECLIZINE
HYDROCHLORIDE TABLETS,
25 mg, Packaged in a) 100
ct Bottles and b) 1000 ct
Bottles
Lot # GS007205 Expiry:
Aug-17; Lot
#:GS007344, Expiry:
Aug-17; Lot #:
GS008089, Expiry: Feb18; Lot #: GS008842,
Expiry: Feb-18; Lot #:
GS009055, Expiry: Feb18; Lot #: GS009131;
Expiry: Feb-18.
a) Lot #: GS005224,
Expiry: Jul-16, Lot:#:
GS007553, Expiry: Nov17; Lot #: GS007858,
Expiry: Nov-17. b) Lot #:
GS002674, Expiry: Jan16; Lot #: GS003402,
Expiry:May-16; Lot #:
GS003582, Expiry: Jun16; Lot #: GS004899,
Expiry: Jun-16; Lot #:
Mylan
Institutional,
Inc. (d.b.a. UDL
Laboratories)
Northwind
Pharmaceutical
s LLC
Pfizer Inc.
93
Product
Type
Product Description
Code Info
Class
Reason for
Recall
Recalling Firm
GS005908, Expiry: Jun17; Lot #: GS006088,
Expiry: Jun-17; Lot #:
GS006254, Expiry: Sep17; Lot #: GS007345,
Expiry: Nov-17; Lot #:
GS007664, Expiry: Nov17; Lot #: GS007803,
Expiry: Nov-17; Lot #:
GS008091, Expiry: Nov17.
Irbesartan and
Hydrochlorothiazide
tablets USP 150 mg/ 12.5
mg, 90-count bottles
Lot #: 24I030, Exp
5/2017
Class III
Cetirizine HCl 10 mg Tablet,
14 count blister packs
Batches: Exp 05/16:
4GE1457; 4GE1500;
4GE1819; 4GE1893;
4HE1255; 4HE1396;
4HE1620; 4HE1656;
4HE1811; 4JE1035;
4JE1212; 4JE1324;
4JE1513; and 4KE1377
Class III
Drugs
HPMC Visoelastic, 20,000
cps, Reference 5122, 515
(Private Label), 600102-001
(Private Label), 600103-001
(Private Label), 2.0 mL in 3mL Syringe
Lot #: V0814H, V0814J,
Exp 08/2016; V1014L,
Exp 11/2016; V1114A,
Exp 11/2016; V0115G,
V0115H, Exp 01/2017;
V0215A, V0215B, Exp
02/2017; V0315G,
V0315H, V0315O, Exp
03/2017; V0515C,
V0515D, Exp 05/2017.
Class III
Drugs
HPMC Visoelastic Topical,
8,000 cps, Reference 5200,
1.5 mL in 3-mL Syringe
Lot #: V1014M, Exp
10/2016; V1214B, Exp
12/2016; V0415H, Exp
4/2017.
Class III
Drugs
Drugs
Labeling:
Incorrect or
Missing Lot
AND/OR Exp
Date.
Failed
Impurity/Degra
dations
Specifications;
impurity
identified as
cetirizine
monosaccharid
e ester
Failed pH
Specification: It
has been
determined
that the pH of
the lots
recalled, may
not meet
specification at
expiry.
Failed pH
Specification: It
has been
determined
that the pH of
the lots
recalled, may
not meet
specification at
expiry.
Teva
Pharmaceutical
Industries
Perrigo
Company PLC
Oasis Medical,
Inc.
Oasis Medical,
Inc.
94
Product
Type
Drugs
Product Description
Code Info
Class
HPMC Visoelastic, 8,000
cps, Reference 51082,
LT5108 (Private Label), 2.0
mL in 3-mL Syringe
Lot #: V0814C, V0814D,
Exp 8/2016; V1014A,
V1014B, Exp 10/2016;
V1214C, Exp 12/2016;
V0115A, V0115B, Exp
01/2017; V0215C, Exp
02/2017; V0315C,
V0315D, Exp 03/2017;
V0515A, V0515B, Exp
05/2017.
Class III
Reason for
Recall
Failed pH
Specification: It
has been
determined
that the pH of
the lots
recalled, may
not meet
specification at
expiry.
Recalling Firm
Oasis Medical,
Inc.
Vaccines
Biologic
s
FLULAVAL QUADRIVALENT
Carton and Syringe
2B472AFLHA839A;
42N4LAFLHA822A;
5AZ7HAFLHA820A;
9A3ZMAFLHA841A;
ZS95ZAFLHA821A;
A2PK7AFLHA821A;
AR57JAFLHA832A;
DR4GFAFLHA847A;
YF5DTAFLHA847A;
F45C5AFLHA842A;
T3J4SAFLHA819A;
XP4J2AFLHA819A;
379MYAFLHA833A;
Class III
Certain lots of
FLULAVAL
QUADRIVALENT
, with observed
loss of potency
below the
minimum
specification
prior to product
expiry, were
distributed.
ID Biomedical
Corp., a
subsidary of
GSK Biologicals
*Please refer to FDA website for further information; http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
95
CURRENT DRUG SHORTAGES
Sufentanil Injection
November 24, 2015
Reason for the Shortage:
 West-Ward has sufentanil on shortage due to manufacturing delays.
 Hospira has sufentanil on shortage due to manufacturing delays.
 Akorn cannot provide a reason for the shortage.
Article link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=823
Source link: http://www.ashp.org/
Hydroxyamphetamine Hydrobromide and Tropicamide Ophthalmic Solution
November 24, 2015
 Akorn has Paremyd on shortage due to manufacturing delays.
 No clinical trial data were found to support the use of Paremyd in the diagnosis of Horner
Syndrome.
Article link:
Dexamethasone and Neomycin sulfate and Polymyxin B sulfate ophthalmic ointment
November 24, 2015
 Perrigo has dexamethasone/neomycin sulfate/polymyxin B sulfate ophthalmic ointment on
shortage due to manufacturing issues.
 Sandoz has dexamethasone/neomycin sulfate/polymyxin B sulfate ophthalmic ointment on
shortage due to increased demand.
 Valeant has dexamethasone/neomycin sulfate/polymyxin B sulfate ophthalmic ointment on
shortage due to manufacturing delay.
Article link:
96
Mupirocin Calcium 2% Cream
November 25, 2015
 GlaxoSmithKline could not provide a reason for the shortage.
 Prasco could not provide a reason for the shortage.
Article link:
Fenoldopam Mesylate Injection
November 30, 2015
Reason for the Shortage: delays

Hospira has Corlopam vials on shortage due to manufacturing delays.
Article link:
Dexamethasone 0.1% Ophthalmic Drops
November 30, 2015

Valeant could not provide a reason for the shortage.
Article link:
Chloroquine Tablets
November 30, 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 has chloroquine tablets on shortage due to manufacturing delays.
Article link:
97
Vecuronium Bromide Injection
December 1, 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:
Synthetic Conjugated Estrogen
December 1, 2015
 Teva discontinued Cenestin in late-August 2014.
 Premarin is not affected by this shortage.
Article link:
http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1087
Estradiol Valerate Injection
December 1, 2015
 Par states the reason for the shortage is manufacturing delay.
 Perrigo states the reason for the shortage is manufacturing issue.
Article link:
Methylphenidate Transdermal
December 2, 2015
 Noven has Daytrana patches on shortage due to problems with adhesive backing and also
increased demand.
98
Article link:
Digoxin Injection
December 2, 2015
 West-Ward states the shortage is due to manufacturing delays.
Article link:
Ondansetron Injection
December 3, 2015
 AuroMedics did not provide a reason for the shortage.
 Fresenius Kabi had ondansetron injection on back order due to increased demand.
 Heritage could not provide a reason for the shortage.
 Sagent had 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:
Deferoxamine Mesylate Injection
December 3, 2015
 Fresenius Kabi states the shortage was due to increased demand.
 Hospira had deferoxamine in short supply due to shortage of an active ingredient and increased
demand.
 Novartis discontinued Desferal 2 gram vials in 2015.
 Teva discontinued all deferoxamine presentations in 2013.
 West-Ward discontinued deferoxamine in September 2014.
 Watson discontinued all deferoxamine presentations.
Article link:
99
Cefpodoxime
December 3, 2015
 Aurobindo could not provide a reason for the shortage.
 Pfizer has discontinued Vantin.
 Ranbaxy has an import ban on all solid medications including cefpodoxime.
 Sandoz could not provide a reason for the shortage.
Article link:
Acetylcysteine Oral and Inhalation Solution
December 3, 2015
 American Regent has a consistent supply of acetylcysteine oral and inhalation solution.
 Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
 Hospira states the reason for the shortage is manufacturing delay.
 Fresenius Kabi states the reason for the shortage is increased demand.
Article link:
Torsemide Injection
December 8, 2015
 Roche discontinued Demadex injection for business reasons. Demadex tablets are not affected
by this shortage.
 American Regent has torsemide on shortage due to manufacturing delays.
Article link:
Dextran Low Molecular Weight (Dextran 40), 10% Injection
December 8, 2015
 Hospira states the reason for the shortage is manufacturing delay and increased demand.
Article link:
100
Dexpanthenol Injection
December 8, 2015
 American Regent has dexpanthenol injection on shortage due to manufacturing delays.
 There are no other suppliers of dexpanthenol injection.
Article link:
Black Widow Antivenin (Latrodectus Mactans)
December 8, 2015
 Merck has low inventory of Antivenin Latrodectus Mactans.
Article link:
Ammonium Chloride Injection
December 8, 2015
 Hospira states the shortage of ammonium chloride is due to manufacturing delays.
 Hospira is the sole manufacturer of ammonium chloride injection.
Article link:
23.4% Sodium Chloride Concentrated Solution for Injection
December 8, 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:
101
14.6% Sodium Chloride Concentrated Solution for Injection
December 8, 2015
 Hospira has 14.6% sodium chloride solutions for injection on shortage due to manufacturing
delays.
Article link:
Tigecycline Injection
December 9, 2015
 Pfizer cannot provide a reason for the Tygacil shortage.
Article link:
Testosterone Cypionate Intramuscular Injection
December 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.
Article link:
102
Sincalide Injection
December 9, 2015
 Bracco Diagnostics had Kinevac injection on shortage due to manufacturing delays.
 There are no approved alternatives to Kinevac for the labeled indications.
Article link:
Phenazopyridine Hydrochloride
December 9, 2015
 Amneal Pharmaceuticals, Avkare, SDA Laboratories discontinued phenazopyridine tablets.
 Gemini Laboratories has new NDC numbers for Pyridium products.
 Marlex could not provide a reason for the shortage.
Article link:
Peginterferon alfa-2b Injection
December 9, 2015
 Merck discontinued the manufacture of PegIntron Redipen prefilled syringes in March 2015
based on a business decision.
 Merck is discontinuing all manufacture and distribution of PegIntron vials on February 1, 2016
based on a business decision.
Article link:
Mesna Injection
December 9, 2015
 Fresenius Kabi had mesna on shortage due to increased demand.
 Mylan could not give a reason for the shortage of mesna.
 Sagent had mesna on shortage due to manufacturing delays.
 Teva had a shortage of mesna injection due to manufacturing delays.
 West-Ward discontinued mesna injection in September 2014.
103
Article link:
Leuprolide Acetate 14-Day Kit
December 9, 2015
 Caraco states the reason for the shortage is increased demand.
 Sandoz states the reason for the shortage was increased demand.
Article link:
Heparin Premixed Bags
December 9, 2015
 Baxter had product on allocation due to increased demand.
 Hospira states the reason for the shortage is increased demand and manufacturing delays.
Article link:
Chlorpromazine Injection
December 9, 2015
 West-Ward is allocating chlorpromazine injection on a weekly basis.
Article link:
Cefotetan Disodium Injection
December 9, 2015
 BBraun has cefotetan on allocation due to current market conditions.
 Fresenius Kabi states the reason for the shortage is manufacturing delay.
104
Article link:
PCA Sterile Empty Vials and Injector
December 10, 2015
 Hospira has Lifecare PCA Sterile empty vials with injector on shortage due to quality assurance
issues.
 These vials are only compatible with Lifecare PCA systems.
Article link:
Morphine PCA Vials
December 10, 2015
 Hospira has morphine PCA vials on shortage due to quality assurance issues.
Article link:
Cytarabine Injection
December 10, 2015
 Fresenius Kabi had cytarabine on shortage due to increased demand.
 Mylan Institutional cannot provide a reason for the shortage.
 West-Ward discontinued cytarabine injection in September 2014.
 Hospira has all cytarabine injection available.
Article link:
105
Verapamil Injection
December 11, 2015
 Hospira has verapamil injection on shortage due to increased demand for the product.
 Hospira is the sole supplier of verapamil injection.
Article link:
Sterile Empty Vials
December 11, 2015
 Hospira states the shortage was due to increased demand.
 Fresenius Kabi reduced production of sterile empty vials to permit increased production of drug
products affected by critical shortages.
 Sterile empty vials may be available from medical supply distributors.
Article link:
Sodium Bicarbonate Injection
December 11, 2015
 Amphastar has sodium bicarbonate on shortage due to increased demand and has a new NDC
number for the product.
 Fresenius Kabi is not currently manufacturing sodium bicarbonate 4.2% 5 mL vials.
 Hospira has sodium bicarbonate on shortage due to manufacturing delays.
 Hospira is the sole supplier of the 4.2% 10 mL syringes used in pediatric patients.
Article link:
Oxytocin Injection
December 11, 2015
 Fresenius Kabi states the shortage was due to increased demand.
 Par Sterile Products (formerly JHP) discontinued generic oxytocin injection in July 2014. Par
Sterile Products discontinued Pitocin 10 unit/mL 50 mL vials in September 2015.
106


West-Ward cannot provide a reason for the shortage.
West-Ward has oxytocin on shortage due to manufacturing delays.
Article link:
Morrhuate Sodium Injection
December 11, 2015
 American Regent has morrhuate sodium injection on shortage due to manufacturing delays.
Article link:
Levetiracetam Injection
December 11, 2015
 American Regent states the reason for the shortage is manufacturing delay.
 Caraco has temporarily discontinued levetiracetam.
 Fresenius states the reason for the shortage is manufacturing delay.
 Hospira has product available.
 Sagent has product available.
 X-Gen states the reason for the shortage is change in manufacturing site.
Article link:
Ketorolac Tromethamine Injection
December 11, 2015
 BD Rx has ketorolac injection available.
 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.
107


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:
Furosemide Injection
December 11, 2015
 Fresenius Kabi has furosemide injection available.
 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:
Etomidate Injection
December 11, 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 on shortage due to manufacturing delays.
 Par Sterile Products discontinued etomidate in early 2015.
Article link:
Dextrose (50%) Injection
December 11, 2015
 Amphastar has 50% dextrose injection on shortage due to increased demand.
 Hospira has 50% dextrose injection on shortage due to increased demand and manufacturing
delays.
Article link:
108
Dextrose (25%) Injection
December 11, 2015
 Hospira has 25% dextrose syringes on shortage due to increased demand.
 Hospira is the sole supplier of 25% dextrose syringes.
Article link:
Carvedilol Tablets
December 11, 2015
 Glenmark cannot provide a reason for the shortage.
 Mylan cannot provide a reason for the shortage.
 Sun Pharma cannot provide a reason for the shortage.
 Teva cannot provide a reason for the shortage.
Article link:
Benztropine Injection
December 11, 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:
Propranolol Hydrochloride Tablets
December 15, 2015
 Actavis cannot provide a reason for the shortage.
 Heritage is not marketing propranolol tablets at this time.
 Northstar discontinued all propranolol tablets in February 2015.
109



Mylan Institutional discontinued propranolol unit-dose tablets. The 10 mg tablets were
discontinued in March 2013, the 20 mg tablets were discontinued in May 2014, and the 40 mg
tablets were discontinued in January 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:
Prochlorperazine Edisylate Injection
December 15, 2015
 Heritage Pharmaceuticals states the reason for the shortage was manufacturing delay.
Article link:
Phenytoin Injection
December 15, 2015
 Hospira has phenytoin sodium injection on shortage due to manufacturing delay.
 X-Gen is no longer marketing phenytoin sodium injection. There may still be some short-dated
100 mg/2 mL vials available.
Article link:
Mitoxantrone Hydrochloride Injection
December 15, 2015
 Hospira has mitoxantrone injection on shortage due to manufacturing delays.
 Teva has mitoxantrone injection on allocation due to current market conditions.
Article link:
110
Metoprolol Injection
December 15, 2015
 American Regent has metoprolol injection on shortage due to manufacturing delays.
 Claris has metoprolol injection on allocation.
 Fresenius Kabi states the shortage is due to increased demand for the product.
 Hospira states the shortage is due to increased demand.
 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 has metoprolol injection on shortage due to increased demand.
Article link:
Methylprednisolone Acetate Injection
December 15, 2015
 Sandoz and Teva could not provide a reason for the shortage.
 Pfizer has Depo-Medrol injection available and is supplying the market.
Article link:
Methylene Blue Injection
December 15, 2015
 American Regent has methylene blue on back order due to manufacturing delays.
Article link:
111
Memantine Hydrochloride
December 15, 2015
 Actavis (formerly Forest) states the reason for the shortage of Namenda XR capsules is
manufacturing delay.
 Actavis launched generic memantine immediate release tablets in July 2015. There are several
other manufacturers of generic memantine immediate release tablets and supplies are
available.
Article link:
Electrolyte Concentrate
December 15, 2015
 American Regent has Nutrilyte and Nutrilyte II on back order due to manufacturing delays.
Article link:
Yellow Fever Vaccine Injection
December 16, 2015
1
 Sanofi Pasteur could not provide a reason for the shortage of YF-Vax.
 There are no other suppliers of yellow fever vaccine.
 Additional information is available
Article link:
Theophylline Extended-Release Tablets
December 16, 2015
 Major has theophylline extended-release tablets on shortage due to increased demand.
 Teva cannot provide a reason for the shortage.
Article link:
112
Source link: http://www.ashp.org
Tamsulosin Hydrochloride Capsules
December 16, 2015
 Boehringer Ingelheim has tamsulosin capsules on shortage due to production delays.
 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:
Pantoprazole Injection
December 17, 2015
 Pfizer has Protonix on shortage due to increased demand.
 Pfizer is the sole supplier of pantoprazole injection.
Article link:
Morphine Injections
December 17, 2015
 Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing
sites and cannot estimate if Astramorph will return.
 West-Ward launched several new morphine sulfate products in late-September 2015.
Article link:
113
Leucovorin Calcium Injection
December 17, 2015
 Fresenius Kabi has leucovorin on shortage due to increase demand.
 Teva had leucovorin on allocation due to increased demand.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired leucovorin
calcium injection from Bedford in July 2014. West-Ward is not actively marketing leucovorin
calcium injection at this time.
 Sagent has leucovorin on shortage due to manufacturing delay.
Article link:
Imipenem Cilastatin Injection
December 17, 2015
 Fresenius has imipenem-cilastatin injection on shortage due to increased demand.
 Hospira has imipenem-cilastatin injection on shortage due to manufacturing delays.
 Merck cannot provide a reason for the shortage of Primaxin injection.
Article link:
Famotidine Injection
December 17, 2015
 West-Ward states the shortage was due to manufacturing delays.
 Oral famotidine products are not affected by this shortage.
 Pfizer launched famotidine injections in March, 2012.
 Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.
 Baxter has famotidine premixed bags available.
Article link:
114
Cefazolin Injection
December 17, 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 had cefazolin on shortage due to manufacturing delays.
 Hospira has cefazolin available.
 Sagent has cefazolin on shortage due to increased demand.
Article link:
Carboplatin Solution for Injection
December 17, 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 states the reason for the shortage is increased demand for the product.
 Sandoz has discontinued carboplatin injection.
 Teva states the reason for the shortage is increased demand for the product.
Article link:
Tobramycin Injection
December 21, 2015
 Fresenius Kabi has tobramycin solution for injection on shortage due to increased demand.
 Hospira has tobramycin on shortage due to manufacturing delays.
 Mylan Institutional could not provide a reason for the shortage.
 Teva has tobramycin solution for injection on shortage due to manufacturing delays.
Article link:
115
Methyldopate Injection
December 21, 2015
 American Regent has methyldopate injection on shortage due to manufacturing delays.
 There are no other suppliers of methyldopate injection.
Article link:
Desmopressin Injection
December 21, 2015
 Teva and Hospira have desmopressin injection on shortage due to manufacturing delays.
 Ferring could not provide a reason for the shortage.
Article link:
Amikacin Injection
December 21, 2015
 West-Ward launched amikacin injection in 2 mL and 4 mL vials in December 2015.
 Teva's product is unavailable due to manufacturing delays.
 Heritage had amikacin injection on shortage due to manufacturing delays.
Article link:
Tropicamide 1% Ophthalmic Solution
December 22, 2015
 Akorn cannot provide a reason for the shortage of tropicamide 1% ophthalmic solution.
 Sandoz cannot provide a reason for the shortage of tropicamide 1% ophthalmic solution.
 Valeant cannot provide a reason for the shortage of tropicamide 1% ophthalmic solution.
Article link:
116
Methylphenidate Hydrochloride Extended Release Oral Presentations
December 22, 2015
 Actavis states the shortage of methylphenidate was due to increased demand. Actavis
discontinued methylphenidate LA 30 mg and 40 mg tablets in late-2015.
 Janssen states the shortage of Concerta was due to increased demand.
 Kremers Urban had Methylphenidate CD on allocation due to increased demand.
 Mallinckrodt states the shortage was due to delay in obtaining raw materials.
 Novartis discontinued Ritalin SR in October 2014.
 Teva introduced generic methylphenidate extended release capsules (CD) in late-September
2012, and these capsules are AB-rated to Metadate CD capsules.
 UCB states methylphenidate ER tablets were on shortage due to supply and demand.
Article link:
Indigo Carmine Injection
December 22, 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:
Hydralazine Injection
December 22, 2015
 Akorn has hydralazine injection on shortage due to increased demand.
 American Regent has hydralazine injection on shortage due to manufacturing delays.
 Fresenius Kabi has hydralazine injection on shortage due to manufacturing delays.
 X-Gen launched hydralazine injection in September 2015.
Article link:
117
Doxorubicin Injection
December 22, 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 on shortage due to manufacturing delays.
 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 manufacturing delay.
 Mylan cannot provide a reason for the reason for the doxorubicin solution for injection
available.
 Actavis has doxorubicin injection available.
Article link:
Cisplatin Injection
December 22, 2015
1
 Fresenius Kabi states the shortage was due to increased demand and manufacturing delays.
2
 Mylan Institutional could not provide a reason for the shortage.
3
 Teva was allocating cisplatin to prevent stockpiling.
 WG Critical Care could not provide a reason for the shortage.
Article link:
Bupivacaine Injection
December 22, 2015
 AuroMedics has not provided a reason for the shortage.
 Fresenius Kabi has Sensorcaine on shortage due to increased demand for the product.
 Hospira has bupivacaine on shortage due to manufacturing delays.
Article link:
118
BCG Vaccine Live Intravesical
December 22, 2015
 Sanofi Pasteur states the reason for the shortage is manufacturing delay.
 Merck states the reason for the shortage was manufacturing delay.
Article link:
Promethazine Injection
December 23, 2015
 West-Ward states the shortage was due to manufacturing delays.
 X-Gen is in the process of changing NDC numbers for promethazine injection and awaiting FDA
approval for two new presentations.
Article link:
Pramipexole Dihydrochloride Tablets
December 23, 2015
 Aurobindo, Mylan, and Sandoz cannot provide a reason for the shortage.
Article link:
Epinephrine Injection
December 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 manufacturing delays.
119
Article link:
Chlorothiazide Oral Suspension
December 23, 2015
 Valeant could not provide a reason for the shortage.
 Valeant recently acquired Diuril oral suspension from Salix.
Article link:
Cefepime Injection
December 23, 2015
 Apotex could not provide a reason for the shortage.
 BBraun has cefepime on allocation due to increased demand.
 Baxter has cefepime on shortage due to increased demand.
 Fresenius Kabi has cefepime injection on shortage due to manufacturing delays.
 Sagent had cefepime injection on shortage due to increased demand.
 Sandoz discontinued cefepime injection in December 2015.
 WG Critical Care has cefepime injection on shortage due to increased demand.
 Hospira has Maxipime on shortage due to increased demand.
Article link:
Calcium Chloride Injection
December 23, 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 manufacturing delay.
 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:
120
Atropine Sulfate Injection
December 23, 2015
 Amphastar had atropine on shortage due to increased demand.
Article link:
Zolpidem Tartrate Immediate Release Tablets
December 28, 2015
 Aurobindo could not provide a reason for the shortage.
 Major could not provide a reason for the shortage.
 Mylan could not provide a reason for the shortage.
 Torrent was unable to provide availability information.
Article link:
Haloperidol Lactate Injection
December 28, 2015
 Patriot Pharmaceuticals could not provide a reason for the shortage.
 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. WestWard is not actively marketing haloperidol lactate at this time.
 Janssen could not provide a reason for the shortage.
Article link:
121
Diltiazem Injection
December 28, 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:
Benzonatate Capsules
December 28, 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:
Milrinone Injection
December 29, 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:
122
Eptifibatide Injection
December 29, 2015
 Merck cannot provide a reason for the shortage.
 AuroMedics launched eptifibatide injection in December 2015.
Article link:
Sodium Nitroprusside Injection
December 30, 2015
 Valeant only has short-dated Nitropress available..
Article link:
Sodium Acetate Injection
December 30, 2015
 American Regent has sodium acetate injection on back order due to manufacturing delays.
 Fresenius Kabi only has short-dated product available.
 Hospira has sodium acetate injection on back order due to manufacturing delays.
Article link:
Potassium Acetate Injection
December 30, 2015
 American Regent has potassium acetate on shortage due to manufacturing delays.
 Hospira has potassium acetate on shortage due to manufacturing delays.
Article link:
123
Potassium Chloride Injection
January 4, 2016
 Baxter has a consistent supply of potassium chloride injection.
 Fresenius Kabi has potassium chloride injection available.
 Hospira has a consistent supply of potassium chloride injection.
Article link:
Nimodipine Oral Solution
January 4, 2016
 Arbor had Nymalize oral solution on temporary back order due to shortage of an active
ingredient.
Article link:
Mupirocin Calcium 2% Nasal Ointment
January 4, 2016
 GlaxoSmithKline states the shortage was due to manufacturing issues.
 Mupirocin ointment 22 gram tubes are not affected by this shortage.
Article link:
Dibucaine Ointment
January 4, 2016
 Perrigo and Fougera cannot provide a reason for the shortage.
 Geritrex introduced dibucaine 1% ointment in March 2014.
 Novartis divested the rights for all Nupercainal ointment products to Ducere Pharma in 2013.
 These products are available Over-The-Counter.
Article link:
124
Albuterol Sulfate Metered Dose Inhalers
January 4, 2016
 Teva has ProAir on allocation due to limited supplies.
Article link:
Vancomycin Hydrochloride Injection
January 6, 2016
 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 had vancomycin injection on allocation due to increased demand.
Article link:
Thrombin Topical Solution (Bovine)
January 6, 2016
 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:
125
Piperacillin Tazobactam Injection
January 6, 2016
 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.
 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 December 2015 for the single dose vials and 1st quarter 2017 for the bulk
vials.
 Sandoz discontinued piperacillin/tazobactam in late 2015.
 WG Critical Care states the reason for the shortage is increased demand.
Article link:
Meropenem Injection
January 6, 2016
 BBraun has meropenem on shortage due to increased demand.
 Hospira has meropenem injection on shortage due to a quality investigation concerning API
availability.
 Sandoz discontinued meropenem injection in January 2015.
 AstraZeneca has Merrem on shortage due to increase demand.
Article link:
Mannitol Injection
January 6, 2016
 American Regent has mannitol injection on shortage due to manufacturing delays.
 Hospira has mannitol injection on shortage due to increased demand.
Article link:
126
Lidocaine Injection
January 6, 2016
 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 generic lidocaine presentations on shortage due to a supply interruption of
API. Xylocaine products are not affected.
 Hospira has lidocaine presentations on shortage due to manufacturing delays and increased
demand.
Article link:
Haloperidol Decanoate Injection
January 6, 2016
 Teva products are on shortage due to manufacturing delays.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired haloperidol
decanoate injection from Bedford in July 2014. West-Ward is not actively marketing haloperidol
decanoate injection at this time.
Article link:
Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride Ophthalmic Solution
January 6, 2016
 Alcon has Cyclomydril ophthalmic solution on back order due to production delays.
Article link:
Clindamycin Injection
January 6, 2016
 Pfizer states the Cleocin Add-Vantage vials are on shortage due to manufacturing delays.
127



Hospira divested clindamycin injection to Alvogen in September 2015. Alvogen will sell Hospira
labeled product until supplies are gone and then will sell Alvogen labeled product.
Sandoz had clindamycin injection on shortage due to increased demand.
Sagent has clindamycin injection on shortage due to manufacturing delays.
Article link:
Ceftriaxone Sodium Injection
January 6, 2016
 Hospira states the reason for the shortage was manufacturing delay.
 Sagent states the reason for the shortage is increased demand.
 Sandoz cannot provide a reason for the shortage.
 WG Critical Care states the reason for the shortage is increased demand.
Article link:
Ceftazidime Injection
January 6, 2016
 IGI Laboratories changed its name to Teligent in late-October 2015.
 Covis divested Fortaz injection to IGI Laboratories in October 2015.
 Hospira has Tazicef on shortage due to increased demand.
 Sagent has ceftazidime injection on shortage due to manufacturing delays.
 Sandoz discontinued ceftazidime 1 gram and 2 gram vials in 2015.
Article link:
Cefotaxime Injection
January 6, 2016
 Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no
longer making the product.
 Baxter discontinued Claforan in late-2015.
 West-Ward has cefotaxime on shortage due to increased demand.
128
Article link:
Calcium Gluconate Injection
January 6, 2016
 American Regent has calcium gluconate on shortage due to manufacturing delays.
 Fresenius Kabi has replaced calcium gluconate glass vials with plastic vials.
 American Regent has issued a statement that all lots of calcium gluconate may contain glass
particles and filters must be used. Do not use if there are visible glass particles and filter all
other product.
Article link:
Atropine Sulfate Ophthalmic Solution
January 6, 2016
 Alcon has discontinued Isopto Atropine.
 Akorn received FDA approval for atropine sulfate 1% ophthalmic solution in July 2014; this new
product launched in January 2015.
 Sandoz has discontinued atropine sulfate ophthalmic solution.
 Valeant discontinued their atropine sulfate 1% ophthalmic solution products in 2015
Article link:
Ampicillin Sulbactam
January 6, 2016
 Hospira states that ampicillin sulbactam vials are on back order due to manufacturing delay.
 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.
Article link:
129
Tigecycline Injection
January 12, 2016
 Pfizer cannot provide a reason for the Tygacil shortage.
Article link:
Thiotepa for Injection
January 12, 2016
 West-Ward launched thiotepa in August 2015.
 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.
 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.
 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.
 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.
Article link:
Sumatriptan Nasal Spray
January 12, 2016
 Sandoz has sumatriptan nasal spray on shortage due to product constraints.
Article link:
130
Flumazenil Injection
January 12, 2016
 Fresenius Kabi had flumazenil on shortage due to short-term manufacturing delays.
 Sandoz discontinued flumazenil injection in 2015.
 West-Ward states the reason for the shortage is increased demand.
Article link:
Acetylcysteine Oral and Inhalation Solution
January 12, 2016
 American Regent has a consistent supply of acetylcysteine oral and inhalation solution.
 Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
 Hospira states the reason for the shortage is manufacturing delay.
Article link:
Acetazolamide Injection
January 12, 2016
 West-Ward is not actively marketing acetazolamide injection at this time.
 Sagent has acetazolamide injection on shortage due to manufacturing delay.
Article link:
* Please refer to ASHP website for more information
131
NEW DRUGS COMING TO MARKET
PRODUCT
MFR
ROUTE
Cotellic
(cobimetinib)
Genentech
Tablet
Adynovate
(recombinate
antihemophilic
factor PEGylated)
Tagrisso
(osimertinib)
Baxalta
Injection
AstraZeneca
Tablet
Darzalex
(daratumumab)
Janssen Biotech
Narcan (Naloxone
Hydrochloride)
Nasal Spray
Ninlaro (ixazomib)
INDICATION
PHARMACOLOG
Y
MARKET
RELEASE
BRAF V600E or
V600K mutation
positive
unresectable or
metastic
melanoma in
comination with
Zelboraf
Bleeding episodes
in patients with
hemophilia A
Mitogenactivated
extracellullar
kinase pathway
inhibitor
Approval
date11/10/15
Factor VIII
analog
Approval
date11/13/15
Injection
T790M positive
non-small cell
lung cancer
Multiple myeloma
Adapt Pharma
Limited
Intranasal
Opioid overdose
Irreversible EGFR
tyrosine kinase
inhibitor
Anti-CD38
monoclonal
antibody
Opioid
antagonist
Takeda
Capsule
Multiple myeloma
Proteasome
inhibitor
Portrazza
(necitumumab)
Eli Lilly
Injection
IgG1 EGFR
monoclonal
antibody
FLUAD (trivalent
influenza virus
vaccine)
Empliciti
(elotuzumab
Novartis
Injection
Bristol-Myers
Squibb and
AbbVie
Injection
Metastatic
squamous nonsmall cell lung
cancer
Influenza disease
prevention in ages
65 and older
Multiple myeloma
Approval
date11/13/15
Approval
date11/16/15
Approval
date11/19/15
Approval
date11/20/15
Approval
date11/24/15
Quillichew ER
Pfizer
Tablet
Attention deficit
hyperactivity
disorder (ADHD)
Trivalent (two
subtype A and
one subtype B)
IgG1
immunostimulat
ory monoclonal
antibody
Norepinephrine
and dopamine
reuptake
inhibitor
Approval
date11/24/15
Approval
date11/30/15
Approval
date12/7/15
132
PRODUCT
MFR
ROUTE
Vonvendi (von
Willebrand factor
recombinant)
Baxalta
Injection
Kanuma
(sebelipase alfa)
Alexion
Injection
Otiprio
(ciprofloxacin otic
suspension)
Otonomy
Otic
Alecensa (alectinib) Genentech
Capsule
Vistogard (uridine
triacetate)
Wellstat
Granules
Packet
Bridion
(sugammadex)
Merck
Injection
Basaglar (insulin
glargine
Eli Lilly and
Boehringer
Inhelheim
Injection
INDICATION
Treatment and
control of
bleeding episodes
associated with
Von Willebrand
disease
Lysosomal acid
lipase deficiency
Bilateral otitis
media with
effusion in
pediatric patients
undergoing
tympanostomy
tube placement
ALK positive
metastatic nonsmall cell lung
cancer
5-Fluorouracil
overdose and
severe toxicity
Reversal of
neumuscular
blockade induced
by rocuronium or
vecuronium
Control of high
blood sugar in
adults and
children with type
1 diabetes and
adults with type 2
PHARMACOLOG
Y
MARKET
RELEASE
Von Willebrand
factor analog
Approval
date12/8/15
Enzyne
replacement
therapy
DNA-gyrase
inhibitor
(fluoroquinolone
)
Approval
date12/8/15
Approval
date12/11/15
ALK/RET tyrosine Approval
kinase receptor
dateinhibitor
12/11/15
5-fluorouracil
antagonist
Approval
date12/11/15
Selective
relaxant binding
agent
Approval
date12/15/15
Long acting
insulin analog
Approval
date12/17/15
133

December 2015 – January 2016

Transcription

Similar documents

Halls Universal

english - Sunpan

Understanding USP 71 Sterility Tests and - Product Sign-in

McNeilus Fond du Lac Ad2

Calpine Northwest Geysers Enhanced Geothermal

Reinoud Vandervelden and Luk Indesteege

principles of injection coding

#7022NM Bud Pierce OCAPA Event Invite.7.27

Presentation - Muzzicycles

Allergy Bazaar – Station 2 Poster Layout Intracutaneous