April 2016 - PerformRx

Transcription

April 2016
Drug Information Update
Table of Contents
NEW GENERICS TO MARKET ........................................................................................................... 2
NEW DRUG ENTITIES....................................................................................................................... 3
NEW INDICATIONS (EXISTING DRUGS) ........................................................................................... 5
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ..................................................................... 6
STUDIES and RECENT TOPICS ........................................................................................................ 11
RECALLS ......................................................................................................................................... 27
CURRENT DRUG SHORTAGES ........................................................................................................ 44
NEW DRUGS COMING TO MARKET………………………………………………………………………………………. 106
Copyright© PerformRx, LLC 2016 All Rights Reserved
1
NEW GENERICS TO MARKET
GENERIC DRUG NAME
STRENGTH & DOSAGE
FORM
GENERIC
MANUFACTURER
Morphine Sulfate/0.9% NaCl/PF
2 mg/2ml Syr
Pharmedium
Oxycodone HCl ER
Oxycodone HCl ER
Oxycodone HCl ER
Darifenacin Hydrobromide
Mebendazole
Dicyclomine HCl
15 mg ER 12H Tab
30 mg ER 12H Tab
60 mg ER 12H Tab
7.5 mg ER 24H Tab
7.5 mg ER 24H Tab
15 mg ER 24H Tab
15 mg ER 24H Tab
100 mg Tab Chew
10 mg/ml vial
Impax
Impax
Impax
Actavis
Par
Actaivs
Par
Amedra
West-Ward
Cefazolin Sod-Water
2 g/20 ml
Cantrell Drug
Doxepin HCl
Oxiconazole Nitrate
5% cream
1% cream
2 mcg/mL-0.2% plastic
bag
25 mg-15 mg Tab
25 mg-30 mg Tab
25 mg-45 mg Tab
12.5 mg-15 mg Tab
12.5 mg-30 mg Tab
12.5 mg-45 mg Tab
12.5 mg-500 mg Tab
12.5 mg-1,000 mg Tab
25 mg Tab
12.5 mg Tab
6.25 mg Tab
1.75 mg Tab Subl
3.5 mg Tab Subl
100 mg Tab ER 12H
50 mcg spray/pump
Renaissance
Fougera
Fentanyl-Ropivacaine-0.9% NaCl
Alogliptin-pioglitazone
Alogliptin-metformin
Alogliptin-metformin
Alogliptin
Alogliptin
Alogliptin
Zolpidem tartrate
Zolpidem tartrate
Carbamazepine ER
Mometasone furoate
Pharmedium
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Perrigo
Gavis
Gavis
Sandoz
Sandoz
BRAND NAME
Morphine Sulfate0.9% NaCl
OxyContin
OxyContin
OxyContin
Enablex
Enablex
Enablex
Enablex
Emverm
Dicyclomine HCl
Cefazolin
Sodium/water
Zonalon
Oxistat
FentanylRopivacaine-NS
Oseni
Oseni
Oseni
Oseni
Oseni
Oseni
Kazano
Kazano
Nesina
Nesina
Nesina
Intermezzo
Intermezzo
Tegretol XR
Nasonex
APPROVAL
DATE
03/14/2016
03/16/2016
03/16/2016
03/16/2016
03/16/2016
03/15/2016
03/16/2016
03/15/2016
03/11/2016
03/25/2016
03/31/2016
03/09/2016
03/51/2016
04/07/2016
03/22/2016
03/22/2016
03/22/2016
03/22/2016
03/22/2016
03/22/2016
03/22/2016
03/22/2016
03/18/2016
03/18/2016
03/22/2016
03/21/2016
03/21/2016
03/25/2016
03/30/2016
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NEW DRUG ENTITIES
DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
NOTES
Maintainence for severe
asthma in adults
Cinqair
reslizumab
3 mg/kg
New Entity
Plaque psoriasis
Taltz
ixekizumab
80 mg/mL
New Entity
Anthrax antitoxin
Anthim
obiltoxaximab
--
New Entity
Unmodified, fulllength
factor VIII compound
Kovaltry
Antihemophilic factor
(recombinant)
Alkylating agent
Evomela
Melphalan
st
Non-narc antitus-1 genantihist-decongest-expect
st
Non-narc antitus-1 gen
antihist-decongest-expect
st
antihist-fdecongetstexpect
st
st
st
Tussigen-N.F.
Tussilan
Chlor-pheniramnphenyleph-DM-GG
Chlorpheniarmnphenyleph-DM-GG
250,500,1000,
2000,3000 unit
vials
50 mg
reconstituted
New Entity
New Entity
--
New Combination
--
New Combination
Chem-Tuss-DME
Chlorpheniramnphenyleph-DM-GG
--
New Combination
Donatussin
--
New Combination
No cough plus
--
New Combination
Tonecol cough
--
New Combination
30 mg/30ml
New Dosage Form
& Strength
250, 500, 1000,
2000 (+/-)
New Entity
2000/ 500mL
New Stregnth
10 mg/ml
New Dosage Form
--
New Combination
250 mg/mL
(1 mL)
New Strength
100 mg
New Entity
Analgesics, narcotics
Hydromorphone HCl
-0.9% NaCl
Hydromorphone HCl/
0.9% NaCl/PF
Factor IX recom,
albumin fusion
Heparin Sod, Porcine/
0.9% NaCl
Dexamethasone
sodium phosp/PF
Emollient combination
No. 101
Hydroxyprogesterone
caproate
Botulism Immune
globulin, Humn
Factor IX preparations
Idelvion
Heparain and related
preparations
Heparin Sodium
0.9% NaCl
Glucocorticoids
Doubledex
Emollients
Ceramax Skin Barrier
Cream
Prenanacy/facilitating/mai
ntaining agent, hormonal
Makena
Antisera
Babybig
Antimigraine preparations
Zembrace Symtouch
Sumatriptan succinate
3 mg/0.5ml
New Strength
Adrenergic agents,
catecholamines
Epinephrine HCl –
0.9% NaCl
Epinephrine HCl In
0.9% NaCL
100 mcg/ 10
New Strength
Adrenergics, Aromatic,
non-catecholamine
Adzenys XR-ODT
Dextroamphetamine/
amphetamine
3.1,6.3,9.4,
12.5,15.7,18.8
mg
New Strength and
Dosage Form
3
DESCRIPTION
BRAND NAME
GENERIC NAME
STRENGTH
NOTES
Factor IX Preparations
Alprolix
Factor IX Rec, FC fusion
protein
250 unit
New strength
Calcium Channel Blocking
Agents
Nicardipine HCl
Nicardipine HCl
2.5 mg/mL
New Strength &
Dosage Form
Local Anesthetics
Ropivacaine HCl
Ropivacaine HCl/PF
0.2% 400 mL
New Dosage Form
Analgesics, Narcotics
Hydromorphone HCl
-0.9% NaCl
0.5 mg/mL
New Dosage Form
& Strength
Anti-convulsants
Active-PAC
300 mg-4%-1%
New Dosage Form
Topical anti-inflammatory
steroidal
Sernivo
Hydromorphone HCl/
0.9% NaCl/PF
Gabapentin/Lidocaine
Menthol
Betamethasone
dipropionate
0.05%
New Dosage Form
Topical Antibiotics
mupirocin
muirocin
2%
New Dosage Form
Neuromuscular blocking
agents
SuccinylcholineChloride
SuccinylcholineChloride
50 mg/2.5 mL
(20 mg/mL)
New Strength
4
NEW INDICATIONS (EXISTING DRUGS)
DRUG
Xalkori (crizotinib)
NEW INDICATION
ROS1 positive metastatic non-small
cell lung cancer (NSCLC)
DATE OF
APPROVAL
03/11/2016
LINKS
Xalkori [package insert] Pfizer.
March 2016
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FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS
FDA announces voluntary recall of all unexpired human and animal compounded drug products
produced by Reliable Drug Pharmacy, San Francisco
[Posted: 3/30/2016] The U.S. Food and Drug Administration (FDA) is alerting health care professionals,
patients,and pet owners of a voluntary recall of all unexpired compounded drug products produced and
distributed by Reliable Drug Pharmacy in San Francisco, due to concerns over mislabeled compounded
drug products. The recalled products were compounded for human and animal use and were distributed
between March 24, 2015, and March 24, 2016.
Source: U.S. Food and Drug Administration (FDA)
Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of
Heart Failure
[Posted: 4/05/2016]
Including:
• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin extended release)
• Nesina (alogliptin)
• Kazano (alogliptin and metformin)
• Oseni (alogliptin and pioglitazone)
ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and
alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney
disease. As a result, FDA is adding new warnings to the drug labels about this safety issue. This
Communication is an update to the 02/11/2014 FDA Drug Safety Communication.
BACKGROUND: Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor
drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
FDA evaluated two large clinical trials conducted in patients with heart disease. These clinical trials were
also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April
2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines
were hospitalized for heart failure compared to patients who received an inactive treatment called a
placebo (see Data Summary in the FDA Drug Safety Communication for additional information). In the
saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8%
of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28
out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the
alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the
placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000
patients.
RECOMMENDATION: Health care professionals should consider discontinuing medications containing
saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a
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patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines
may be required. Patients taking these medicines should contact their health care professionals right
away if they develop signs and symptoms of heart failure such as:
• Unusual shortness of breath during daily activities
• Trouble breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach
Patients should not stop taking their medicine without first talking to their health care professionals.
Sterile Drug Products by Medaus Pharmacy: FDA Alert - Lack of Sterility Assurance
[Posted: 04/01/2016]
ISSUE: FDA is alerting health care professionals and patients not to use unexpired drug products that are
intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of
sterility assurance. Medaus’ products were distributed nationwide and internationally.
BACKGROUND: During FDA’s recent inspection of Medaus’ facility, investigators observed insanitary
conditions, including poor sterile production practices, which raise concerns about Medaus’ ability to
assure the sterility of drug products that it produced. Administration of a non-sterile product, intended
to be sterile, may result in serious and potentially lifethreatening infections or death. The Alabama
Board of Pharmacy ordered Medaus to cease sterile compounding operations on March 22, 2016. On
March 29, 2016, FDA recommended Medaus recall all unexpired drug products that are intended to be
sterile. To date, Medaus has not voluntarily recalled any drug products intended to be sterile. Therefore,
FDA alerts health care professionals and patients not to use drug products marketed as sterile from
Medaus. To date, FDA is not aware of any adverse events associated with drug products made by
Medaus. Patients who have received drug products produced by Medaus and have concerns should
contact their health care professional.
RECOMMENDATION: Health care professionals and patients should immediately check their medical
supplies, quarantine any drug products marketed as sterile from Medaus, and not administer them.
OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety
Communication - Do Not Use
[Posted: 03/29/2016]
ISSUE: The FDA is recommending consumers, businesses, schools, and health care providers stop using
OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions,
including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to
explode. Due to adverse event reports to the FDA and the company’s failure to address the device’s
safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that
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patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for
serious adverse health consequences, such as burns and death. The FDA will continue to work with
OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public
informed if significant new information becomes available.
BACKGROUND: OxySure Portable Emergency Oxygen System is intended to produce oxygen for
emergency use. Since June 2013, OxySure Therapeutics, Inc. has distributed at least 1,000 units of the
OxySure Portable Emergency Oxygen System, Model 615 nationwide. These devices may be purchased
without a prescription and can be used in businesses, schools, and other public places (e.g.., gyms,
shopping malls, and airports). See the FDA Safety Communication for additional information.
RECOMMENDATION: The FDA recommends customers stop using the OxySure Portable Emergency
Oxygen System, Model 615 and immediately transition to an alternative FDAcleared emergency oxygen
device.
CMS caves to drugmakers' plea, partially delays enforcement of Medicaid drug rule
[Posted: April 5, 2016]
By Virgil Dickson
Drug manufacturers are breathing a sigh of relief after the CMS announced it will delay enforcement of
a rule that changes the way state Medicaid agencies reimburse pharmacies for prescription drugs.
The CMS pushed back the enforcement date for inhalation, infusion, instilled, implanted or injectable
drugs to July. Pharmaceutical companies wanted a delay until October.
Source:modernhealthcare.com
The Pain Points of Opioid Policy
[Posted: Apr 4, 2016]
By Vann R. Newkirk II
The federal government is pushing some modest reforms in its fight against the opioid epidemic, but
what will it really take to defeat addiction?
Source: theatlantic.com
Medicare Is Often Overbilled by Hospices, and Pays Twice for Some Drugs
[Posted: APRIL 2, 2016]
By Robert Pear
Hospices often bill Medicare for a higher level of care than patients need, and Medicare often pays
twice for the prescription drugs provided to people who are terminally ill, federal investigators say in a
new report. The extra cost to Medicare was put at more than $260 million a year.
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Source: nytimes.com
In Rare Turn, Competing Health Groups Agree on Drugs, Risk
[Posted: March 30, 2016]
Caitlin Owens The strange dance between the pharmaceutical industry, insurers and the Obama
administration has taken a new turn. When it comes to one of the wonkiest healthcare policies out
there, all three seem close to agreement. They want prescription drugs to be included in determinations
about whether a certain pools of patients are riskier than others.
Source: morningconsult.com
Sanders, other lawmakers seek NIH hearing to override drug patent
By Ed Silverman
Senator Bernie Sanders and several other Democratic lawmakers are urging the Obama administration
to hold a public hearing to determine whether the National Institutes of Health should override the
patent on a prostate cancer drug in an effort to drive down prices.
Source: statnews.com
Obama Confronts Opiate Abuse Epidemic as Death Toll Mounts
By Alex Wayne
State Medicaid programs for the poor would have to cover treatment for drug abuse under a rule the
Obama administration will issue today, as the U.S. government grapples with an epidemic of painkiller
and heroin abuse that kills tens of thousands of Americans a year.
Source: bloomberg.com
Federal officials, advocates push pill-tracking databases
[Posted: Mar 28, 2016]
By Matthew Perrone
The nation's top health officials are stepping up calls to require doctors to log in to pilltracking databases
before prescribing painkillers and other high-risk drugs.
The move is part of a multi-pronged strategy by the Obama administration to tame an epidemic of
abuse and death tied to opioid painkillers like Vicodin and OxyContin. But physician groups see the
proposed requirement to check the databases as overly burdensome, another time-consuming task that
takes away from patient care.
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Source: ap.org
FDA outlines standards for anti-abuse generic painkillers
By Matthew Perrone
Federal officials are encouraging generic drugmakers to develop painkillers that are harder to abuse, the
latest in a string of steps designed to combat abuse of highly-addictive pain drugs like codeine and
oxycodone.
The Food and Drug Administration published draft guidelines outlining testing standards for harder-toabuse generic painkillers. The agency has already approved five brand-name opioid pain drugs which are
designed to discourage abuse. The current version of OxyContin, for example, is difficult to crush,
discouraging abusers from snorting or dissolving the tablets to get high.
Source: ap.org
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STUDIES and RECENT TOPICS
Drug dosing goes digital with software to personalize medication
By Leah Samuel
A new algorithm may take the guesswork out of medicating patients with cancer, bacterial infections,
organ transplants, and other conditions that require very precise drug dosing.
FDA warns patients to avoid drugs from compounding pharmacy in Austin
The U.S. Food and Drug Administration is advising health care professionals and patients not to use
products from I.V. Specialty, Ltd., an Austin-based compounding pharmacy where federal inspectors
reported unsanitary conditions.
Source: statesman.com
FDA: Two diabetes drugs may be linked to heart failure risk
By Steven Reinberg
Diabetes drugs containing saxagliptin and alogliptin may raise the risk of heart failure, particularly in
patients with heart or kidney disease, U.S. health officials warned Tuesday.
Drugs containing these ingredients are Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin
extended release), Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and
pioglitazone), the U.S. Food and Drug Administration said.
Source: medicalxpress.com
ACC: Pharmacist Intervention Can Cut Cardiovascular Risk
A community pharmacy-based intervention can reduce cardiovascular disease (CVD) risk among highrisk patients, according to a study published online April 4 in the Journal of the American College of
Cardiology. The research is being published to coincide with the annual meeting of the American College
of Cardiology, held from April 2 to 4 in Chicago.
Source: physiciansbriefing.com
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‘Truly terrifying’: Chinese suppliers flood US and Canada with deadly fentanyl
By David Armstrong
The dozen packages were shipped from China to mail centers and residences in Southern California. One
box was labeled as a “Hole Puncher.”
In fact, it was a quarter-ton pill press, which federal investigators allege was destined for a suburban Los
Angeles drug lab. The other packages, shipped throughout January and February, contained materials
for manufacturing fentanyl, an opioid so potent that in some forms it can be deadly if touched.
Exclusive: Makers took big price increases on widely used U.S. drugs
[Posted: Apr 5, 2016]
By Caroline Humer
Major drug companies took hefty price increases in the U.S., in some cases more than doubling listed
charges, for widely used medications over the past five years, a Reuters analysis of proprietary data
found.
Source: reuters.com
FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk
By Steven Reinberg
Diabetes drugs containing saxagliptin and alogliptin may raise the risk of heart failure, particularly in
patients with heart or kidney disease, U.S. health officials warned Tuesday.
Drugs containing these ingredients are Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin
extended release), Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and
pioglitazone), the U.S. Food and Drug Administration said.
Source: healthday.com
Big Drug Companies Hiked Prices on Popular Medications, Report Finds
By Daniel White
Big pharma says it uses the money to support new research Major U.S. drug manufacturers set steep
price increases on popular drugs for arthritis, high cholesterol, asthma and other common ailments,
according to an analysis of price data.
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Source: time.com
New cholesterol methods needed in wake of failed drugs, heart researchers say
By Ransdell Pierson
New ways of controlling cholesterol, including possibly directly injecting "good" HDL cholesterol into
patients, need to be studied following the failure of promising treatments from Eli Lilly, Pfizer Inc and
Roche Holding AG, according to top heart researchers.
Source: yahoo.com
Victoza® (liraglutide 1.8 mg) Provided Superior HbA1c Reductions in Adults with Type 2 Diabetes
Compared to Continued Sitagliptin Treatment
Findings from a clinical trial comparing Victoza® (liraglutide 1.8 mg) and sitagliptin (100 mg), both in
combination with metformin, demonstrated that switching from sitagliptin to Victoza® provided
superior HbA1c reductions vs continuing with sitagliptin treatment in adults with type 2 diabetes.
Results from the LIRA-SWITCH trial were presented at the Endocrine Society's 98th Annual Meeting and
Expo (ENDO 2016) in Boston, MA, US.
Source: yahoo.com
Studies show high out-of pocket costs limit access to lifesaving specialty drugs
"Specialty drugs" have become important treatment options for many serious and chronic diseases, and
in some conditions like cancer they represent the only chance for long-term survival. But, insurers
increasingly require patients to share the high costs of these medications. Two new studies led by
researchers at the Perelman School of Medicine at the University of Pennsylvania have found evidence
that such cost-sharing arrangements are associated with significant reductions in access to these drugs.
Both papers are published online in the American Journal of Managed Care.
BRILINTA Preferred Over clopidogrel In Updated American College of Cardiology and American Heart
Association Guideline in Acute Coronary Syndrome
AstraZeneca (AZN) today confirmed that the American College of Cardiology (ACC) and American Heart
Association (AHA) have released a treatment guideline on the duration of dual antiplatelet therapy
(DAPT). BRILINTA (ticagrelor) is now preferred over clopidogrel for the management of patients with
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acute coronary syndrome (ACS) who have received a coronary stent and in non-ST Elevation acute
coronary syndrome (NSTE-ACS) patients treated with medical therapy alone (Class IIa LOE: B-R). This
update is the first time the ACC/AHA has recommended BRILINTA over clopidogrel for patients who
have experienced a ST-elevation myocardial infarction (STEMI).
Source: yahoo.com
GlaxoSmithKline promises reduced drug patents to help world's poor
By Ben Hirschler
GlaxoSmithKline is to adopt a graduated approach to patenting its medicines, depending on the wealth
of different countries, in order to make drugs more affordable in the developing world.
Britain's biggest drugmaker said on Thursday it would not file patents in low-income states, leaving the
way clear for generic companies to make cheap copies of its drugs without fear of being sued.
Source: reuters.com
The opioid crisis: Changing the culture of prescribing
[Posted: 03/29/16]
By POLITICO Staff
Opioid-related deaths have reached an all-time high in the United States. More than 47,000 people died
in 2014, and the numbers are rising. The Centers for Disease Control and Prevention this month released
prescribing guidelines to help primary care physicians safely treat chronic pain while reducing opioid
dependency and abuse. Given that the guidelines are not binding, how will the CDC and the Department
of Health and Human Services make sure they make a difference? What can payers and providers do to
encourage a countrywide culture shift?
Source: politico.com
IMS Health: Surge in Biosimilars to Drive Significant Change in Health System Costs, Patient Access and
Competition by 2020
By Tor Constantino
Greater acceptance of biosimilar medicines in a growing number of therapy areas and an active pipeline
of 56 new products in clinical development are expected to deliver total savings of as much as $110
billion to health systems across Europe and the U.S. through 2020, according to new research released
today by the IMS Institute for Healthcare Informatics. Biosimilars, which compete with original biologic
medicines, can provide physicians and patients with greater access to advanced treatments and offer
budgetary relief to payers in the face of intensifying healthcare cost pressures. Health systems best
positioned to capitalize on the benefits of biosimilars support functioning competitive markets—where
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manufacturers are motivated to participate over the long term, and where physicians are at the heart of
the decision-making process.
Source: imshealth.com
FDA says biosimilar labels should rely on reference drug data
By Adam Rubenfire
Biologic manufacturers may not be pleased with the long-awaited biosimilar labeling guidelines released
Thursday by the Food and Drug Administration. The agency is recommending that labeling for
biosimilars use the clinical data gathered by the product the biosimilar is intended to emulate.
Regulators would also allow biosimilar labels to state that the product is biosimilar to the reference
product but has product-specific modifications.
Source: modernhealthcare.com
Fridge-Sized Machine Makes Prescription Drugs 'On Demand'
By Amy Norton
Scientists have created a compact machine that can churn out thousands of doses of prescription
medication in a day -- putting the capabilities of a drug-manufacturing plant into a device the size of a
kitchen refrigerator.
Experts said the advance could eventually allow on-the-spot drug production in special circumstances -on the battlefield, during epidemics, after natural disasters, or in cases where a drug is needed for a rare
medical condition, for instance.
Report Shows Theranos Testing Plagued by Problems
[Posted: MARCH 31, 2016]
By Andrew Pollack
Medical testing done by the closely watched start-up Theranos was plagued by quality control problems
that could have led to inaccurate results for patients, according to an inspection report released by
federal regulators on Thursday.
Source: nytimes.com
15
There’s a Way to Treat Opiate Addiction, So Why Isn’t It Being Used?
By Alice Park
In the U.S., nearly two million people abuse prescription opioid painkillers. For many, an initial
prescription to treat pain leads to a dangerous dependence and misuse that contributes to around
14,000 deaths each year.
Source: time.com
Cash is not king: FTC sues drug maker over pay-to-delay deal
By Ed Silverman
In its latest effort to thwart pay-to-delay deals, the US Federal Trade Commission filed a lawsuit on
Wednesday against Endo Pharmaceuticals and three other drug makers for allegedly paying generic
rivals to delay launches of copycat versions of two painkillers. This is the first lawsuit, however, in which
the agency argues that a deal involving a so-called authorized generic thwarted competition.
Tainted Drug May Still Be in U.S. Almost Decade After Deaths
By Anna Edney
Heparin tainted with unauthorized Chinese-made ingredients may be on the market in the U.S. and the
Food and Drug Administration hasn’t moved swiftly enough to prevent it, according to a congressional
probe nearly a decade after hundreds of deaths were linked to sullied batches of the blood-thinning
drug.
Women being charged for birth control that should be free under Obamacare
By Paul Muschick
When she returns to the pharmacy in about a month to refill her daughter's birth control prescription, a
Northampton woman isn't sure what to expect.
The pills are supposed to be provided at no cost under the Affordable Care Act. Yet twice in the past
three months she was charged for them and had to fight with her prescription plan to get hundreds of
dollars back.
Source: mcall.com
16
The FDA just made the abortion pill easier to get
[Posted: March 30]
By Sandhya Somashekhar and Laurie McGinley
The Food and Drug Administration has changed its guidelines for use of the abortion pill, potentially
increasing access to a method of pregnancy termination that has been heavily restricted in some states.
Source: washingtonpost.com
Mortgages For Expensive Health Care? Some Experts Think It Can Work.
By Michelle Andrews
A Massachusetts Institute of Technology economist and Harvard oncologist have a proposal to get highly
effective but prohibitively expensive drugs into consumers’ hands: health care installment loans.
Writing last month in the journal Science Translational Medicine, the authors liken drug loans to
mortgages, noting that both can enable consumers to buy big-ticket items requiring a hefty up-front
payment that they could not otherwise afford.
Source: khn.org
FDA Review Times Steadily Decreasing, Report Finds
[Posted: March 29,2016]
By Zachary Brennan
Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined
since 2009, according to a report released Tuesday by the California Life Sciences Association and
Boston Consulting Group.
Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five
years later, that average has been cut by more than half to nine months in 2014. In addition, the number
of applicants waiting more than two years for an FDA review has fallen from more than 25% of
applicants in 2000 to none by 2013.
Source: raps.org
Pharmacies boost controlled substance e-scripts
By Russell Redman
ROCKVILLE, Md. — Last year, retail pharmacies greatly accelerated implementation of technology for
electronic prescribing of controlled substances (EPCS).
17
Eighty-two percent of U.S. retail pharmacies are now EPCS-enabled, up 21% from 2014, according to a
report released Thursday by e-prescribing solution provider DrFirst. Nearly all states have at least 60% of
retail pharmacies EPCS-enabled, with over half of states having more than 80% of retail pharmacies
capable of accepting and processing EPCS orders.
Source: chaindrugreview.com
Physician Group Calls On Government To Rein In Drug Prices
By Alison Kodjak
It's not just patients who are getting tired of ever rising drug prices. Doctors are joining the chorus of
frustration.The latest voice? The American College of Physicians, whose membership includes 143,000
internal medicine doctors. It published a position paper Monday calling for the government and industry
to take steps to rein in spiraling costs.
Source: npr.org
Drugmakers move to counteract expiring patents with new respiratory drugs
By Rebecca Mayer Knutsen
Recently plagued by patent expirations and generic competition, the respiratory space has found new
energy through innovative beyond-the-pill partnerships. Indeed, an enhanced understanding of disease
drivers continues to breathe new life — pun unabashedly intended — into a sector on the cusp of
rebound.
Source: mmm-online.com
Gov't panel backs drug for delusions in Parkinson's patients
By Matthew Perrone
WASHINGTON (AP) -- Federal health experts have endorsed an experimental drug intended to treat
psychotic delusions and behaviors that often afflict patients with Parkinson's disease, the debilitating
movement disorder.
Source: ap.org
Pros and cons of electronic prescriptions
New rules have gone into effect requiring doctors in New York to send prescriptions in to pharmacies
electronically instead of handing patients a handwritten prescription slip.The requirement is intended to
18
help fight prescription painkiller abuse and reduce errors. Eprescribing is part of a nationwide trend,
although it's voluntary, not required, most places. About 60 percent of prescriptions are now sent
electronically, Paul Uhrig, chief administrative officer of Surescripts, the leading network for transmitting
e-prescriptions, told the Associated Press.
Source: cbsnews.com
Fingerprint recognition, locks could be coming to pill bottles
By Christine Stapleton
ATLANTA — Imagine a prescription drug bottle that only can dispense your medication at the exact time
you should take it, in the proper amount and only after it scans your fingerprint and confirms your
identity. Or another bottle with a combination lock that looks like it came off a bicycle lock.
Source: palmbeachpost.com
Lack of competition leads to EpiPen pricing woes
By Adam Rubenfire
An epinephrine auto-injector can mean the difference between life and death for 1 in 50 Americans who
could suffer from an anaphylactic reaction. But the high cost of the devices can make it difficult for some
patients to obtain them.
Source: modernhealthcare.com
FDA Proposes a Tier-Based Approach to Evaluate “Bioequivalence” of Abuse Deterrence of Generic
SODF Opioids
By Kurt R. Karst
Ever since FDA Commissioner Dr. Robert M. Califf's February 2016 call for a sweeping review of FDA
policies concerning opioids (in response to growing pressure from Congress), the Agency has been on a
tear to meet that call with new policies and requirements. There's the recent announcement that the
Agency will require class-wide safety labeling changes for immediate-release opioid pain medications (as
well as a related citizen petition response - Docket No. FDA-2014-P-0205). And now FDA is tackling
generic opioids.
Source: fdalawblog.net
19
7 Potential Blockbuster Drugs May Hit the Market This Year
By Mark Terry
The analysts at Thomson Reuters have consulted their crystal balls and come up with seven drugs
coming out this year that will likely hit blockbuster status—defined as marking more than $1 billion
annually.
Source: biospace.com
UPDATE 1-FDA staff says Acadia's drug for Parkinson's disease psychosis is effective
U.S. Food and Drug Administration staff members said on Friday Acadia Pharmaceuticals Inc's drug to
treat psychosis associated with Parkinson's disease was an effective treatment for the condition. The
drug, Nuplazid, is a new chemical compound and could be the first drug specifically approved in the
United States for Parkinson's disease psychosis (PDP).
Source: reuters.com
Benlysta Found Steroid-Sparing in Lupus
[Posted: 03.26.2016]
By Diana Swift
The monoclonal antibody belimumab (Benlysta) may have potential as a corticosteroidsparing drug
when added to standard-of-care treatment for systemic lupus erythematosus (SLE), a post-hoc analysis
suggested.
Source: medpagetoday.com
Many patients with high stroke risk don’t get needed blood thinners
By Lisa Rapaport
Patients who have a heart rhythm disorder that can come with a high risk of stroke often don’t receive
blood-thinning medications that can make this complication less likely, a U.S. study suggests.
Researchers studied almost 430,000 people with a condition known as atrial fibrillation, an irregular
rapid heartbeat that can lead to stoke, heart failure and chronic fatigue.
Source: reuters.com
20
Older Americans are taking their vitamins — and that could be dangerous
[Posted: March 24]
By Carolyn Y. Johnson
The number of older Americans at risk for a potentially life-threatening drug interaction doubled
between 2005 and 2010, according to a new study -- but not just from the prescriptions they fill at the
pharmacy or the medicines they buy over the counter.
Antibiotics before age 2 increases risk for childhood obesity
While early antibiotic use has been associated with a number of rare long-term health consequences,
new research links antibiotics to one of the most important and growing public health problems
worldwide—obesity. A study published online in Gastroenterology, the official journal of the American
Gastroenterological Association, found that administration of three or more courses of antibiotics
before children reach an age of 2 years is associated with an increased risk of early childhood obesity.
Better inhaler lessons can prevent asthma emergencies
By Lisa Rapaport
Reuters Health - A major weakness of asthma care is that many patients don’t know how to use inhalers
to deliver life-saving medicine when they’re gasping for air. The fix may be as simple as taking more time
to teach patients how the devices work, a U.S. study suggests.
Source: reuters.com
Study Finds No Heart Risk From SSRI Antidepressants
By Alan Mozes
Widely used antidepressants known as selective serotonin reuptake inhibitors (SSRIs) don't appear to
raise the risk for heart trouble among young and middle-age patients, a large analysis suggests.
Commonly prescribed SSRIs include Celexa, Lexapro, Prozac, Paxil and Zoloft.
21
AstraZeneca's Brilinta Doesn't Best Aspirin in Stroke Trial
By Marthe Fourcade Ketaki Gokhale
AstraZeneca Plc’s heart medicine Brilinta didn’t outperform aspirin in a three-month long test on
preventing further attacks in patients who have suffered a stroke. In a clinical trial dubbed Socrates,
Brilinta taken twice daily was compared to a once-daily dose of aspirin in patients for two forms of
stroke. Those taking the drug had fewer heart attacks, other stroke or death, but the difference wasn’t
statistically significant, the Londonbased company said in a statement Wednesday.
How much should that drug cost?
Depends what disease it treats
By Ed Silverman
If a drug does a good job of treating lung cancer, but is less effective at combating pancreatic cancer,
you might think that the price should be lower for pancreatic cancer patients. But it doesn’t work that
way in the convoluted world of pharmaceutical pricing, where a one-size-fits-all approach is generally
used.
Many seniors using dangerous drug combinations
By Ashley Welch
One in six seniors in the U.S. regularly uses potentially dangerous combinations of prescription and overthe-counter medications and dietary supplements, according to new research. The study, published
today in JAMA Internal Medicine, showed a two-fold increase over a five-year period.
Source: cbsnews.com
FDA Approved 3D Printed Drug Available In The US
By Jennifer Hicks
A continued step forward in the treatment of epilepsy and the power of 3D printing. According to the
Centers for Disease Control (CDC), there were 2.4 million adults living with active epilepsy in 2013. In
2015, the U.S. Food and Drug Administration (FDA) approved Spritam, the first 3D printed prescription
drug to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.
Source: forbes.com
22
Antipsychotic Drugs Tied to Risk of Early Death in Parkinson's Patients
By Randy Dotinga
New research suggests that Parkinson's patients who are given antipsychotics to treat dementia and
psychosis may be more likely to die early. However, the medications provide important benefits and the
study authors aren't suggesting that these patients stop taking them. And it's still not clear exactly why
there seems to be an increased risk of early death.
FDA adds new warnings on risk of addiction, overdose and death for prescription opioids
By Lenny Bernstein
The Food and Drug Administration announced Tuesday that it will require new warnings about the risk
of addiction, abuse, overdose and death for short-acting opioid pain medications, a step toward curbing
the epidemic of narcotic use in the United States.
Studies warn of side effects from long-term use of heartburn medications
By David Templeton
For decades, people have spent billions on such drugs as Prevacid, Prilosec and Nexium to treat
heartburn; in fact, Nexium’s $6 billion in sales a year makes it one of nation’s topselling drugs.
But stop the music. Stomach acid isn’t a bad thing — if it stays in the belly. In fact, stomach acid is
necessary for proper digestion and absorption of minerals, vitamins, B-12 and nutrients, with further
responsibilities in killing bad, and fostering good, bacteria in the stomach and intestinal tract.
Source: post-gazette.com
Multidrug TB Prophylaxis Not Needed in Advanced HIV
[Posted: 03.20.2016]
By Salynn Boyles
Patients with advanced HIV infection initiating anti-retroviral therapy who were treated with isoniazid
alone to prevent tuberculosis had similar survival rates as patients treated with a standard four-drug
anti-tuberculosis regimen in a multi-national, randomized, controlled trial.
Source: medpagetoday.com
23
Common painkillers are more dangerous than we think
[Posted: 17-Mar-2016]
By Aarhus University
Many Danes are prescribed NSAIDs for the treatment of painful conditions, fever and inflammation. But
the treatment also comes with side effects, including the risk of ulcers and increased blood pressure. A
major new study now gathers all research in the area. This shows that arthritis medicine is particularly
dangerous for heart patients, and also that older types of arthritis medicine, which have not previously
been in focus, also appear to be dangerous for the heart.
Source: eurekalert.org
Glenmark Gets Final FDA Nod For Migraine Headache Relief Drug
Glenmark Pharma has received final nod from the USFDA to manufacture and market therapeutical
equivalent of Endo Pharmaceutical's Frova tablets, used to treat migraine headaches, in the American
market.
Source: ndtv.com
Patients in Pain, and a Doctor Who Must Limit Drugs
By Jan Hoffman
MILFORD, Neb. — Susan Kubicka-Welander, a short-order cook, went to her pain checkup appointment
straight from the lunch-rush shift. “We were really busy,” she told Dr. Robert L. Wergin, trying to smile
through deeply etched lines of exhaustion. “Thursdays, it’s Philly cheesesteaks.”
Her back ached from a compression fracture; a shattered elbow was still mending; her lefthip sciatica
was screaming louder than usual. She takes a lot of medication for chronic pain, but today it was just not
enough.
Source: nytimes.com
Heart Failure Drug Could Treat Herpes Virus, Suggests Study
[Posted: 03/15/2016]
By Ryan Bushey
Early research suggests the heart failure drug spironolactone hinders infection from the Epstein-Barr
virus, a pathogen linked to mono and different types of cancer. Spironolactone is a “potassium-sparing
diuretic” that prevents potassium levels from dropping too low and ensures the body doesn’t absorb
excess levels of salt. Congestive heart failure patients also take the drug to treat fluid retention.
Source: dddmag.com
24
New CDC Painkiller Guidelines: Go Slow, Use Less
[Posted: Mar 15 2016]
By Maggie Fox
New guidelines from the Centers for Disease Control and Prevention urge doctors to take it easy in
prescribing the potentially killer drugs, making it clear that overprescribing is driving an epidemic of
opioid addiction.
Source: nbcnews.com
Waste in Cancer Drugs Costs $3 Billion a Year, a Study Says
By Gardiner Harris
WASHINGTON — The federal Medicare program and private health insurers waste nearly $3 billion
every year buying cancer medicines that are thrown out because many drug makers distribute the drugs
only in vials that hold too much for most patients, a group of cancer researchers has found.
Source: nytimes.com
Five Companies Face Big FDA Decisions This Month
[Posted: 3/14/2016]
By Mark Terry
A decision by the U.S. Food and Drug Administration (FDA) has an enormous impact, both positive or
negative, on drug companies. At least five drug companies are facing big FDA decisions this month.
Source: biospace.com
Marijuana-Based Drug Found to Reduce Epileptic Seizures
By Andrew Pollack
An experimental drug derived from marijuana has succeeded in reducing epileptic seizures in its first
major clinical trial, the product’s developer announced on Monday, a finding that could lend credence to
the medical marijuana movement.
Source: nytimes.com
25
Shkreli's Strategy to Jack Up Drug Prices May Be Curbed by FDA
By Anna Edney
With a small regulatory change, the U.S. Food and Drug Administration may have just stopped the next
Martin Shkreli. The agency said Friday that it will prioritize review of new applications for generic drugs
that would compete with treatments made by only one company. That could help make it less profitable
for somebody like Shkreli, who was until last year the chief executive officer of Turing Pharmaceuticals
AG, from buying an old, patent-expired drug with no competition and jacking up the price.
VA expands hepatitis C treatment to all patients with the virus
By Patricia Kime
The Veterans Affairs Department will begin providing hepatitis C treatment to all veterans in its health
system who have the virus, regardless of their disease stage, VA officials said Wednesday.
Having received a boost in funding from Congress late last year for the costly medications needed to
cure hepatitis C, the VA is now able to treat the 174,000 veterans in its health system who have the
disease, according to a VA release.
Source: militarytimes.com
First generic version of Viagra approved by FDA
By Mary Brophy Marcus
The FDA has approved the first-ever generic version of Viagra. The Pennsylvania-based pharmaceutical
company Teva will be adding the drug, sildenafil citrate, for male erectile dysfunction to its roster of
hundreds of other generic medications. Teva told CBS News the drug will go on sale December 11, 2017.
Source: cbsnews.com
26
RECALLS*
Product
Type
Product Description
Code Info
Class
Reason for Recall
Recalling Firm
Drugs
CITRULLINE (L) in 25 g, 100 g,
500 g and 1 kg plastic bottles
Lot #s: 95482/A, 95482/B,
95482/C, 95482/D,
96453/A, 96453/B,
96453/C, and 96453/D,
Exp. 10/31/2014
Class I
Labeling: Label
Mix-Up: FDA
tested samples of
API from Medisca,
labeled as to
contain LCitrulline, and
results revealed
no L-Citrulline
was present.
Levels of N-acetylleucine were
found instead.
Medisca Inc
661 State Route 3
Unit C
Plattsburgh, NY
12901-6531
Drugs
Akttive High Performance Fat
Burner Gold dietary
supplement capsules, 30count bottle
Lot # 000815004400; Exp
12/17
Class I
Marketed
Without An
Approved
NDA/ANDA:
Dietary
supplements
contains
undeclared
sibutramine,
desmethylsibutra
mi ne and
phenolphthalein
based on FDA
sampling.
Life and More LLC
5771 NW 112th Ave
Apt 112
Doral, FL 33178-4161
Drugs
ACETAMINOPHEN EXTRASTRENGTH PAIN RELIEVER
tablets, 500 mg, 100-count
bottle
lot # 45810; Exp. 05/18
Class I
Medline Industries
Inc
1 Medline Pl
Mundelein, IL 600604485
Drugs
fentaNYL Citrate, Preservative
Free, 5 mcg per mL In 0.9%
Sodium Chloride, 1 mL Total
Volume For IV Use
Lot #: 15002077M, Exp
04-02-2015
Class I
Labeling: Label
Error on Declared
Strength- Bottles
containing 500
mg
acetaminophen
tablets mislabeled
to contain 325 mg
tablets.
Subpotent Drug
Drugs
fentaNYL Citrate, Preservative
Free, 10 mcg per 1 mL In 0.9%
Lot #: 15002250M, Exp
04-02-2015
Class I
Subpotent Drug
CLASS I
Pharmedium
Services, LLC
150 N Field Dr Ste
350
Lake Forest, IL
60045-2506
Pharmedium
Services, LLC
27
Product
Type
Product Description
Code Info
Class
Reason for Recall
Sodium Chloride, 1 mL Total
Volume For IV Use
Recalling Firm
150 N Field Dr Ste
350
Lake Forest, IL
60045-2506
Premiere Sales Group
21446 Golden
Triangle Rd
Santa Clarita, CA
91350-2911
Drugs
Rhino 7 3000, 6 count bottles
All lots
Class I
Marketed without
an Approved
NDA/ANDA:
Products contain
undeclared active
pharmaceutical
ingredients;
desmethyl
carbondenafil and
dapoxetine.
Drugs
NATUREAL BURN FAT
NATURE, 30-count capsules,
packaged in clear plastic
bottle
All lots
Class I
Marketed
Without an
Approved
NDA/ANDA:
Product contains
undeclared
sibutramine.
Inaffit, LLC
356 Urban Ave
Gaithersburg, MD
20878-4054
Drugs
Rhino 7 Platinum 3000, 1
count Blister Pack
All lots
Class I
Marketed without
an Approved
NDA/ANDA:
Products contain
undeclared active
pharmaceutical
ingredients;
desmethyl
carbondenafil and
dapoxetine.
Premiere Sales Group
21446 Golden
Triangle Rd
Santa Clarita, CA
91350-2911
Drugs
ACETAMINOPHEN REGULARSTRENGTH PAIN RELIEVER
tablets, 325 mg, 100-count
bottle.
lot # 45810; Exp. 05/18
Class I
Labeling: Label
Error on Declared
Strength- Bottles
containing 500
mg
acetaminophen
tablets mislabeled
to contain 325 mg
tablets.
Medline Industries
Inc
1 Medline Pl
Mundelein, IL 600604485
Drugs
Vitamin Supplement (Vial) D3,
(cholecalciferol (vit D3)/lipoic
acid/ubiquinol/
methylcobalamin/py
ridoxine/methionin
e/inositol/choline bitartrate
AICACABF@3,
AICECABF@2,
AJBFCABF@4,
ABCCABF@4,
AICACABF@5,
AICECABF@3,
Class I
Superpotent
Drug: The vitamin
supplement
contains an
extremely high
level of vitamin
Glades Drugs Inc.
109 S Lake Ave
Pahokee, FL 334761803
28
Product
Type
Product Description
Code Info
Class
Reason for Recall
Recalling Firm
USP) capsules, 60, 120 or 180
count vials
AJBHCABF@2,
ABCCABF@5,
AICBCABF@1,
AICECABF@4,
AJCBCABF@1,
ABGCABF@4,
AICBCABF@2,
AICECABF@5,
JCBCABF@2,
BACDCABF@5,
AICBCABF@3,
AICICABF@3,
BAAGCABF@2,
BADACABF@3,
AICBCABF@4,
AJADCABF@1,
BAAICABF@1,
BACCABF@3,
AICECABF@1,
AJBECABF@6,
BABCCABF@2 and
BBAECABF@5, Exp
02/20/2016
Drugs
Ultimate Herbal Slimcap
Capsules, 350 mg*, 30-count
bottles
Lot #: 05/02/2015 to
05/01/2017
Class I
Marketed
Without An
Approved
NDA/ANDA:
product marketed
as a dietary
supplement was
found to be
tainted with
undeclared
sibutramine, a
previously
approved
controlled
substance that
was removed
from the U.S.
market in October
2010 for safety
reasons, in this
tainted product
renders it an
unapproved drug.
Fit Firm and Fabulous
1504 Lincoln Way
Apt 212
Mc Lean, VA 221025856
Drugs
Magnesium Sulfate in Water
for Injection, (0.325 mEq
Lot: 53-113-JT, Exp
1NOV2016
Class I
Labeling:
Incorrect
Hospira Inc.
275 N Field Dr
D3
(Cholecalciferol
29
Product
Type
Product Description
Code Info
Class
Mg++/mL) 40 mg/mL, 2 g
Total, 50 mL Single-Dose
Drugs
APEXXX tablets, 300 mg,
packaged in 1-count blister
cards
Reason for Recall
Recalling Firm
Barcode: Primary
bag labeling may
be mislabeled
with the wrong
barcode which
scans in as
heparin sodium.
Lake Forest, IL
60045-2579
All lots
Class I
Marketed
Without An
Approved
NDA/ANDA:
tainted product
marketed as a
dietary
supplement.
Product found to
be tainted with
sildenafil, an FDA
approved drug for
the treatment of
male erectile
dysfunction,
making this an
unapproved drug.
Nuway Distributors,
LLC
9020 Pecky Cypress
Way
Orlando, FL 328366562
CLASS II
Drugs
Haloperidol Oral Solution, USP
(Concentrate) 2 mg/mL 15 mL
amber bottle
Lot #846881; Exp 01/16
Class II
Defective
Container:
Confirmed
customer
complaints of
leaking bottles.
Safecor Health, LLC
317 New Boston St
Woburn, MA 018016231
Drugs
Pramipexole Dihydrochloride
Tablets 0.125 mg, 90 Ct
Bottles
Lot #: BPA512A; Expiry:
06/2017.
Class II
Presence of
Foreign
Tablets/Capsules:
Presence of a
comingled
Carbimazole 5 mg
tablet.
Macleods Pharma
Usa Inc
666 Plainsboro Rd
Bldg 200 Ste 230
Plainsboro, NJ 085363030
Drugs
Midazolam HCl Syrup, 10
mg/5 mL, 5 mL unit dose cups
Lot: 932333, Exp
08/04/16
Class II
Presence of
Foreign
Substance:
customer
complaint that
one unit dose cup
contained a small
Safecor Health, LLC
317 New Boston St
Woburn, MA 018016231
30
Product
Type
Product Description
Code Info
Class
Reason for Recall
Recalling Firm
piece of
cardboard
contaminant.
Drugs
SyrSpend SF, Suspending Base
Lot #s: 15J26-U05027457; 15J26-U05027473
Class II
Microbial
Contamination of
Non-Sterile
Products:
Syrspend SF and
Syrspend SF
Grape Flavor are
being recalled
due to the
presence of yeast
Microbial
Contamination of
Non-Sterile
Products:
Syrspend SF and
Syrspend SF
Grape Flavor are
being recalled
due to the
presence of yeast.
Fagron, Inc
2400 Pilot Knob Rd
Saint Paul, MN
55120-1118
Drugs
Lot #s: 15A05-U03022765; 15G29-U03025975
Class II
Drugs
Lot #s: 15I21-U01027370; 15I21-U01026920; 15J19-U05027406
Class II
Microbial
Contamination of
Non-Sterile
Products:
Syrspend SF and
Syrspend SF
Grape Flavor are
being recalled
due to the
presence of yeast.
Fagron, Inc
2400 Pilot Knob Rd
Saint Paul, MN 55120
Drugs
Bupivacaine, 0.25%, 450 mL
All lots
Class II
Lack of Assurance
of Sterility: Firm is
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Berkeley, CA 947051973
Drugs
calcium elemental, 3 mg/10
mL, 200 mL unit
All lots
Class II
Lack of Assurance
Abbott's
Compounding
Fagron, Inc
2400 Pilot Knob Rd
Saint Paul, MN
55120-1118
31
Product
Type
Product Description
Code Info
Class
Drugs
Estradiol cypionate/Test
cyprionate; 2 mg/50 mg/ml,
unit size 5 mL
All lots
Class II
Drugs
Folic Acid, 5 mg/mL, 30 mL
unit size, refrigerate
All lots
Class II
Drugs
Folic Acid, 10 mg/mL, 6 mL
unit
All lots
Class II
Drugs
Hydroxycobalamine 30
mg/mL, 90 mL unit size
All lots
Class II
Reason for Recall
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
Recalling Firm
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
32
Product
Type
Product Description
Code Info
Class
Drugs
hydroxyprogesterone in
sesame 250 mg/mL, 2 mL, 5
mL, 6 mL, 8 mL unit sizes
All lots
Class II
Drugs
hydroxyprogesterone w/ pres;
1 mg/mL, 20 mL unit size
All lots
Class II
Drugs
Insulin, 70/30, 10 mL unit size
All lots
Class II
Drugs
methylcobalamine 10 mg/mL,
10 mL and 12 mL unit sizes
All lots
Class II
Drugs
methylcobalamine 1 mg/mL, 1
mL and 10 mL unit sizes
All lots
Class II
Reason for Recall
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
Recalling Firm
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
33
Product
Type
Product Description
Code Info
Class
Drugs
methylcobalamine 4 mg/mL, 5
mL and 30 mL unit sizes
All lots
Class II
Drugs
papaverine prostaglandin 30
mg/30 mcg/mL, 5 mL unit size
All lots
Class II
Drugs
progesterone/testosterone
(ss oil) 0.25/20 mg/mL, 10 mL
unit size
All lots
Class II
Drugs
testosterone cypionate, 200
mg/mL, 6 mL and 10 mL unit
sizes
All lots
Class II
Reason for Recall
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
Recalling Firm
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
34
Product
Type
Product Description
Code Info
Class
Drugs
testosterone cypionate, 100
mg/mL, 10 mL unit size
All lots
Class II
Drugs
papaverine phent, 25
mg/0.833 mg/mL, 20 mL unit
size
All lots
Class II
Drugs
Menthocin Patch with
Lidocaine-Strong (Menthol
5%, Capsaicin 0.0375%,
Methyl Salicylate 20%,
Lidocaine 0.5%)
Lot#: 20150326, Exp
03/2018
Class II
Drugs
TEARS Naturale FREE (dextran
70 and hypromellose 2910)
lubricant eye drops, 1% and
0.3%, Preservative Free, 0.9
mL (0.03 FL OZ) Single-Use
Vials, packaged in 60-count
Single-Use Vials
Lot #: KRJ006, Exp 09/17
Class II
Drugs
Medicated Better Braids, La
Laque (salicylic acid) Spray,
2%,12 Fl. OZ. (355 ml.) bottle
Lot #: 9AD5
Class II
Reason for Recall
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Lack of Assurance
recalling all
unexpired lots of
sterile
compounded
products after
FDA inspection
found concerns of
lack of sterility
assurance.
Marketed without
an approved
NDA/ANDA
Lack of Assurance
of Sterility: Some
single-use vials
may be filled with
water rather than
the product
solution and the
firm cannot
guarantee the
sterility of the
water-filled vials.
Microbial
Contamination of
a Non-Sterile
Products: The
product had a
positive
Staphylococcus
aureus test result.
Recalling Firm
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Abbott's
Compounding
Pharmacy, Inc.
2320 Woolsey St
Bonita
Pharmaceuticals, LLC
6380 Commerce
Drive
Westland, MI 481859120
Alcon Research, Ltd.
6201 South Fwy
Fort Worth, TX
76134-2099
Keystone
Laboratories Inc
1103 Kansas St
Memphis, TN 381061913
35
Product
Type
Drugs
Product Description
Code Info
Class
Reason for Recall
Recalling Firm
Capecitabine tablets USP 500
mg, Cytotoxic Agent, Rx Only,
120 tablets per bottle
Lot # 3A404012V, Exp.
4/2016
Class II
Failed Dissolution:
Out of
Specification test
results (low) at
the 18 month
time-point.
Teva North America
425 Privet Rd
Horsham, PA 190441220
Drugs
Baclofen, 2.5 mg/mL INJ, in
100 mL vial
Lot # 07142015#7192@1,
Exp 09/12/2015;
09112015#7192@1, Exp
11/10/2015;
10082015#7192@9, Exp
12/07/2015;
11302015#71920@1, Exp
1/30/2015
Class II
Lack of assurance
of sterility
TexasStar Pharmacy
3033 W Parker Rd Ste
100
Plano, TX 750238000
Drugs
0.9% Sodium Chloride
Irrigation, USP, 500 mL bottle
Lot # G120162, Exp 11/18
Class II
PRESENCE OF
PARTICULATE
MATTER: Product
complaint for the
presence of
particulate matter
identified as an
insect.
Baxter Healthcare
Corp.
1 Baxter Pkwy
Deerfield, IL 600154625
Drugs
Thyrogen (thyrotropin alfa for
injection), 0.9 mg/mL
Lot #: E4029Y02 (carton),
E4029 (vial) Exp 09/2016
Class II
Presence of
Particulate
Matter: Glass
particles found in
the product after
reconstitution.
Drugs
Thyrogen (thyrotropin alfa for
injection), 0.9 mg/mL after
reconstitution, For
intramuscular injection
Lot #s: E4029Y03,
E4029Y04, E4029Y06,
E4029Y07, Exp 12/2017
Class II
Presence of
Particulate
Matter: Glass
particles found in
the product after
reconstitution.
Drugs
Alendronate Sodium Tablets,
USP, 70 mg*, 4-count
Lot #s: JKP2234A,
JKP2235A, Exp 04/17
Class II
Failed
Impurities/Degrad
a tion
Specifications:
Observed levels
of highest
unknown impurity
exceeding
specification limit
at the 3 month
stability time
Genzyme
Corporation
500 Kendall Street
675 West Kendall/55
Cambridge Parkway
Cambridge, MA
02142-1108
Genzyme
Corporation
500 Kendall Street
675 West Kendall/55
Cambridge Parkway
Cambridge, MA
02142-1108
Sun Pharma Global
Fze
Office # 43 Block Y
Saif Zone
Sharm
36
Product
Type
Product Description
Code Info
Class
Reason for Recall
point.
Lack of Assurance
of Sterility
Drugs
Morphine Sulfate 6
mg/ml/Bupivacaine HCL 32
mg/ml, vol. 22 ml syringe
BUD: 5/3/2016
Class II
Drugs
Baclofen 5000 mcg/ml, vol. 20
ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Hydromorphone HCL 10
mg/ml/Baclofen 460
mcg/ml/Bupivacaine HCL, vol.
40 ml
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Morphine Sulfate 0.5
mg/ml/Baclofen 1000
mcg/ml/, vol. 20 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Hydromorphone 12
mg/ml/Baclofen 450 mcg/ml,
vol. 20 ml, syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Morphine Sulfate 9
mg/ml/Sufentanil Cit 180
mcg/ml/Bupivacaine HCL 33
mg/ml, vol. 20 ml vial
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Sufentanil Cit 1000
mcg/ml/Baclofen 300 mcg/ml,
vol. 20 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Morphine Sulfate 0.6 mg/ml,
vol. 200 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Morphine Sulfate 20
BUD: 5/3/2016
Class II
Lack of Assurance
Recalling Firm
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
37
Product
Type
Product Description
Code Info
Class
mg/ml/Bupivacaine HCL 11.3
Reason for Recall
of Sterility
Drugs
Morphine Sulfate 20
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Morphine Sulfate 10 mg/ml,
vol. 20 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Baclofen 2000 mcg/ml, vol. 20
ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
mg/ml/Fentanyl Citrate 0.15
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Recalling Firm
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
38
Product
Type
Product Description
Code Info
Class
Reason for Recall
Drugs
vol. 20 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Fentanyl Citrate 1.275
mg/ml/Baclofen 150
mg/ml/ Clonidine HCL 450
mcg/ml, vol. 40 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Hydromorphone HCL 1
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
vol. 20 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Hydromorphone HCL 7
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Sufentanil Cit 200
mcg/ml/Clonidine HCL 1600
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Recalling Firm
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
39
Product
Type
Product Description
Code Info
Class
Reason for Recall
Drugs
Sufentanil Cit 200
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
vol. 42 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
vol. 20 ml syringe
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Hydromorphone HCL 0.5
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Drugs
Sufentanil Cit 50
BUD: 5/3/2016
Class II
Lack of Assurance
of Sterility
Recalling Firm
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
Hartley Medical
Center Pharmacy,
Incorporated
113 W Victoria St
Long Beach, CA
90805-2162
CLASS III
Drugs
Candesartan Cilexetil Tablets,
16 mg, a) 30 count (NDC
00781-5938-31) and b) 90
count (NDC 00781-5938-92)
bottles
a) 3022288 12/2015
3025988 03/2016
3025989 04/2016
3030459 08/2016
3030460 08/2016
3032087 10/2016
3032088 10/2016
3034506 12/2016
3035952 01/2017
3035953 01/2017 b)
3022287 12/2015
3025990 04/2016
3030458 08/2016
3032086 09/2016
3035954 01/2017
Class III
Failed
Impurities/Degrad
a tion
Specifications; 9
month stability
timepoint
Sandoz Inc
100 College Rd W
Princeton, NJ 085406604
Drugs
Paricalcitol Capsules, 1 mcg,
Lot #s: C404795,
Class III
Failed
Dr. Reddy's
40
Product
Type
Product Description
Code Info
Class
Reason for Recall
Recalling Firm
Tablet/Capsule
Specifications:
Product recalled
due to reports of
breakage and
leakage of
Paricalcitol
capsules.
Laboratories, Inc.
107 College Rd E
30 capsules per bottle
C404796, C404797, Exp
05/2016; C406272,
C406273, C406274,
C406518, Exp 07/2016;
C409586, C409587, Exp
11/2016; C409588, Exp
12/2016; C501835,
C501836 , C501837, Exp
02/2017; C503797,
C503798, Exp 05/2017;
C505009, Exp 06/2017;
C505568, C505569, Exp
07/2017
Drugs
Lot #s: C404653,
C404654, C404655, Exp
05/2016; C505010, Exp
06/2017
Class III
Failed
Tablet/Capsule
Specifications:
Product recalled
due to reports of
breakage and
leakage of
Paricalcitol
capsules.
Dr. Reddy's
Laboratories, Inc.
107 College Rd E
Drugs
Lot #s: C404440, Exp
04/2016; C404946, Exp
05/2016; C505704, Exp
07/2017
Class III
Failed
Tablet/Capsule
Specifications:
Product recalled
due to reports of
breakage and
leakage of
Paricalcitol
capsules.
Dr. Reddy's
Laboratories, Inc.
107 College Rd E
Drugs
Triamcinolone Diacetate
Injectable Suspension, 40
mg/mL, 10mL Multi-Dose Vial
for Injection
Lot Number:
12212015@8, Do Not Use
Beyond: 03/22/2016,
"Compounded on
December 21, 2015"
Class III
Labeling:
Incorrect or
Missing Lot
and/or Exp Date:
some vials may be
mislabeled with
an incorrect
"Compounded"
date, lot number,
and "Do Not Use
Beyond " date or
BUD (Before Use
Date) that may be
longer than
intended.
Isomeric Pharmacy
Solution, LLC
2401 S Foothill Dr
Salt Lake City, UT
84109-1479
41
Product
Type
Drugs
Product Description
Code Info
Class
Reason for Recall
Recalling Firm
risperiDONE ORALLY
DISINTEGRATING TABLETS, 2
mg, 30 Ct Bottles
Lot #: MP4967, Expiry:
04/2016.
Class III
Failed
Impurities/Degrad
a tion
Specifications:
Out of
specification for a
known degradant.
Zydus
Pharmaceuticals USA
Inc
73 Route 31 N
Pennington, NJ
08534-3601
Drugs
Normosol-M and 5% Dextrose
(multiple electrolytes and 5%
dextrose) Injection Type 1,
USP, 1000 mL Single-Dose
Container bag
Lot #: 56-853-FW, Exp
01AUG2017
Class III
Labeling:
Incorrect or
Missing Lot
and/or Exp Date:
Confirmed
customer report
of an incorrect
expiration date
printed on the
primary container
labeled
"01AUG1017"
rather than
"01AUG2017".
Hospira Inc.
275 N Field Dr
Lake Forest, IL
60045-2579
Drugs
sulfur8 medicated LIGHT
FORMULA (sulfur) antidandruff hair& scalp
conditioner, 2%, packaged in
a) 2 OZ (57g) jar (UPC 0 75610
43510 8), and b) 4 OZ (113g)
jar (UPC 0 75610 43610 5), 1
dozen jars per case, J.
Strickland & Co., PO Box 1637,
Olive Branch, MS 38654
Atorvastatin Calcium 10 mg,
10 tablets per blister,100count package
Lot #: 33UF
Class III
Subpotent Drug:
failed at the 3 and
6 month stability
time points.
J. Strickland and Co
10420 Desoto Rd
Olive Branch, MS
38654-5301
Lot #GS005602; Exp.
10/15 Lot #GS008855;
Exp. 09/17 Lot
#GS009074; Exp. 08/17
Lot #GS009393; Exp.
08/17 Lot #GS009760;
Exp. 10/17 Lot
#GS010599; Exp. 11/17
Class III
Failed
Impurities/Degrad
a tion
Specifications
Golden State Medical
Supply Inc.
5187 Camino Ruiz
Camarillo, CA 930128601
Drugs
Lot #GS008856; Exp.
09/17 Lot #GS010268;
Exp. 09/17 Lot
#GS010600; Exp. 11/17
Class III
Failed
Impurities/Degrad
a tion
Specifications
Drugs
Lot #GS009075; Exp.
09/17 Lot #GS009763;
Exp. 09/17 Lot
Class III
Failed
Impurities/Degrad
a tion
Supply Inc.
5187 Camino Ruiz
Supply Inc.
5187 Camino Ruiz
Drugs
42
Product
Type
Product Description
Code Info
Class
#GS010178; Exp. 10/17
Reason for Recall
Specifications
Drugs
Lot #GS005603; Exp.
10/15 Lot #GS006691;
Exp. 08/17 Lot
#GS009073; Exp. 08/17
Lot #GS009395; Exp.
08/17 Lot #GS009764;
Exp. 10/17
Class III
Failed
Impurities/Degrad
a tion
Specifications
Drugs
Scrub-Stat 4 (chlorhexidine
gluconate) Foam Forming
Solution, 4%, packaged in a)
800 mL Plastic (HDPE) Bottles
Lot #: a) L041051, Exp 04
/17; L060151, L061951,
Exp 06 /17; b) L060151,
L061951, Exp 06 /17
Class III
Subpotent drug
Recalling Firm
Supply Inc.
5187 Camino Ruiz
Ecolab Inc
370 Wabasha St N
Saint Paul, MN
55102-1323
BIOLOGICS
none
*Please refer to FDA website for further information; http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
43
CURRENT DRUG SHORTAGES
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Acetohydroxamic
Acid (Lithostat)
Tablets
7/15/2014
Currently
in Shortage
Mission
Pharmacal
(Reverified
01/21/2015)
250 mg (NDC 01780500-01)
Unavailable - no
product available
for release.
Shortage of an
active
ingredient.
Ammonium
Chloride Injection
3/8/2013
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5 mEq/mL; 20 mL vial
(NDC 0409-6043-01)
Next delivery and
estimated
recovery TBD
Other
Available
Name
1/6/2016
Currently
in Shortage
Shire US Inc.
(Reverified
03/11/2016)
AGRYLIN® (anagrelide
hydrochloride)
Dosage Form: 0.5 mg
capsules for oral
administration (NDC
54092-063-01)
1/6/2016
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
1mg 100 (NDC 001725240-60)
Estimated
availability: end of
March 2016
Other
1/6/2016
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
0.5 mg 10 (NDC
00172-5241-60)
Estimated
availability: end of
March 2016
Other
Atropine Sulfate
Injection
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
0.4 mg/mL 1 mL
single-dose vial
package of 25(NDC
00517-0401-25)
Available in
limited supply.
Demand
increase for the
drug
Atropine Sulfate
Injection
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
1 mg/mL 1 mL singledose vial package of
25 (NDC 00517-101025)
Available for NDC
00517-1010-25.
Other
Atropine Sulfate
Injection
Currently
in Shortage
Amphastar
Pharmaceuticals
Inc./IMS
(Reverified
03/15/2016)
0.1 mg/mL; 10 mL
Luer-Jet Prefilled
Syringe(NDC 763293339-1 Old NDC 05483339-00)
Product available
Demand
increase for the
drug
Atropine Sulfate
Injection
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.1 mg/mL; 10 mL
Ansyr syringe(NDC
0409-1630-10)
Next delivery:
Early April 2016;
Estimated
recovery: 2Q 2016
Other
Anagrelide
Hydrochloride
Capsules
Anagrelide
Hydrochloride
Capsules
Anagrelide
Hydrochloride
Capsules
44
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Atropine Sulfate
Injection
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.05 mg/mL; 5 mL
Ansyr syringe(NDC
0409-9630-05)
Next delivery: Mid
March 2016;
Estimated
recovery: 1Q 2016
Other
Atropine Sulfate
Injection
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.1 mg/mL; 5 mL
Lifeshield syringe(NDC
0409-4910-34)
Available
Releasing product
consistently
Other
Atropine Sulfate
Injection
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.1 mg/mL; 10 mL
Lifeshield syringe(NDC
0409-4911-34)
Available
Other
Atropine Sulfate
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Reverified
03/10/2016)
0.4 mg/mL 20 mL vial
(NDC 0641-6006-10)
West-Ward has
available
inventory.
Demand
increase for the
drug
Caffeine
Anhydrous
(125mg/mL);
Sodium Benzoate
(125mg/mL)
Injection
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
2 mL single-dose vial
package of 10 (NDC
00517-2502-10)
Unavailable for
(NDC 00517-250210).
Demand
increase for the
drug
Calcium Chloride Inj.
USP 10% 10mL LuerJet Prefilled Syringe
(NDC 0548-3304-00)
new (NDC 763293304-1)
Product available
Demand
increase for the
drug
Name
Calcium Chloride
Injection USP
5/11/2015
Currently
in Shortage
Amphastar
Pharmaceuticals
Inc./IMS
(Reverified
03/15/2016)
Calcium Chloride
Injection USP
5/11/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
100 mg/mL; 1 g/10 mL
Ansyr™ Plastic Syringe
(NDC 0409-1631-10)
Available
Releasing product
consistently
Other
Hospira Inc.
(Reverified
03/22/2016)
100 mg/mL; 1 g/10 mL
LifeShield™
Abboject™ Glass
Syringe (20 G x 1
1/2)(NDC 0409-492834)
Next delivery:
Early May 2016;
Estimated
recovery: 2Q 2016
Other
Calcium Chloride
Injection USP
5/11/2015
Currently
in Shortage
45
Date First
Reported
Name
Calcium
Gluconate
Injection
1/10/2013
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
10% 50 mL vial;
Calcium (0.465
mEq/mL) Preservative
Free (NDC 0517-395025)
American Regent
is currently
releasing Calcium
Gluconate 100 mL
vial (NDC 05173900-25).
Other
10% 100 mL vial;
Calcium (0.465
mEq/mL) Preservative
Free (NDC 0517-390025)
Unavailable for
NDC 00517-390025.
Demand
increase for the
drug
Calcium
Gluconate
Injection
1/10/2013
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
Calcium
Gluconate
Injection
1/10/2013
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
10% 100 mg/mL 10
mL single dose vial
(NDC 63323-311-19)
Available
Demand
increase for the
drug
Calcium
Gluconate
Injection
1/10/2013
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
10% 100 mg/mL 50
mL single dose vial
(NDC 63323-311-59)
Available
Demand
increase for the
drug
Calcium
Gluconate
Injection
1/10/2013
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
10% 100 mg/mL 100
mL pharmacy bulk
package (NDC 63323311-66)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Apotex Corp.
(Revised
03/25/2016)
1gm; (25 Vials) (NDC
60505-0749-5)
On backorder.
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Apotex Corp.
(Revised
03/25/2016)
1gm; (25 Vials)(NDC
60505-6093-5)
On backorder.
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Apotex Corp.
(Revised
03/25/2016)
10 gm; (10 Vials) (NDC
60505-0769-0)
Back order
expected to
resolve by April
2016
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Apotex Corp.
(Revised
03/25/2016)
10 gm; (10 Vials) (NDC
60505-6094-0)
On backorder.
Demand
increase for the
drug
4/1/2014
Currently
in Shortage
B. Braun Medical
Inc. (Reverified
06/18/2015)
2 g Cefazolin (NDC
0264-3105-11)
Product available
for contracted
customers based
on historical use.
Demand
increase for the
drug
4/1/2014
Currently
in Shortage
B. Braun Medical
Inc. (Reverified
06/18/2015)
1 g Cefazolin NDC
(NDC 0264-3103-11)
Product available
for contracted
customers based
on historical use.
Demand
increase for the
drug
Cefazolin
Injection
Cefazolin
Injection
46
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
USP 1 g/50 mL (NDC
0338-3503-41)
Available
Demand
increase for the
drug
4/1/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
500 mg / single dose
vial (NDC 63323-023610)
Available
Demand
increase for the
drug
4/1/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1 g / single dose vial
(NDC 63323-0237-10)
Available
Demand
increase for the
drug
4/1/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
10 g / PBP (NDC
63323-0238-61)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
20 g / PBP (NDC
63323-449-61)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
1 g; vial (NDC 04090805-01)
Available
Other
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 g; Pharmacy Bulk
Package (NDC 04090806-01)
Available
Other
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
1 g; Add-Vantage vial
(NDC 0409-2585-01)
Available
Other
4/1/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
500mg 10mL vial
(NDC 25021-100-10)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
1g 10mL vial (NDC
25021-101-10)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
500 mg (NDC 007819338-95)
Available
Other
Cefazolin
Injection
Cefazolin
Injection
Cefazolin
Injection
Cefazolin
Injection
47
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
500 mg (NDC 007813450-95)
Available
Other
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
1g (NDC 00781-345196)
Available
Other
Cefazolin
Injection
4/1/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
10g (NDC 007813452-95)
Available
Other
4/1/2014
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
1 g/10 mL vial (NDC
0143-9924-90)
Inventory
available
Demand
increase for the
drug
4/1/2014
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
10 mg/100 mL vial
(NDC 0143-9983-03)
Inventory
available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
500 mg/10mL vial
(NDC 0143-9923-90)
Inventory
available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
WG Critical Care
(Reverified
01/28/2016)
500mg vial (NDC
44567-0706-25)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
WG Critical Care
(Reverified
01/28/2016)
1g vial (NDC 445670707-25)
Available
Demand
increase for the
drug
Cefazolin
Injection
4/1/2014
Currently
in Shortage
WG Critical Care
(Reverified
01/28/2016)
10g vial (NDC 445670708-10)
Available
Demand
increase for the
drug
7/22/2015
Currently
in Shortage
Apotex Corp.
(Revised
03/25/2016)
Cefepime for Injection
USP 1 gm (10 Vials)
(NDC 60505-6030-4)
Backorder
expected to
resolve by May
2016
Demand
increase for the
drug
7/22/2015
Currently
in Shortage
Apotex Corp.
(Revised
03/25/2016)
Cefepime for Injection
USP 2 gm (10
Vials)(NDC 605056031-4)
Backorder
expected to
resolve by May
2016
Demand
increase for the
drug
Cefazolin
Injection
Cefazolin
Injection
Cefepime
Injection
Cefepime
Injection
48
Date First
Reported
Name
Status
Company
Presentation
Availability
Shortage
Reason
Demand
increase for the
drug
Cefepime
Injection
7/22/2015
Currently
in Shortage
B. Braun Medical
Inc. (New
07/22/2015)
Cefepime 1 g (NDC
0264-3193-11)
On allocation to
contract
customers only
due to increase in
product demand.
No interruption in
supply.
Cefepime
Injection
7/22/2015
Currently
in Shortage
B. Braun Medical
Inc. (New
07/22/2015)
Cefepime 2 g (NDC
0264-3195-11)
Available. No
interruption in
supply.
Demand
increase for the
drug
7/22/2015
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Cefepime Injection 1
gram/50mL GALAXY
Container (NDC 03381301-41)
Available for
existing
customers.
Demand
increase for the
drug
7/22/2015
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Cefepime Injection 2
gram/100mL GALAXY
Available for
existing
customers.
Demand
increase for the
drug
7/22/2015
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1 g single dose vial
sterile powder (NDC
63323-326-20)
Backordered.
Next release
anticipated April
2016
Demand
increase for the
drug
Cefepime
Injection
7/22/2015
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
2 g single dose vial
sterile powder (NDC
63323-340-20)
Backordered.
Next release
anticipated Q2 2016
Demand
increase for the
drug
Cefepime
Injection
7/22/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
2g Single Dose ADDVantage™ Glass Vial
(NDC 0409-0218-01)
Available
Other
Cefepime
Injection
7/22/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
(NDC 0409-0217-01)
Available
Other
Cefepime
Injection
7/22/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
1g Single Dose Glass
Fliptop Vial (NDC
0409-0219-01)
Available
Releasing product
consistently
Demand
increase for the
drug
Cefepime
Injection
Cefepime
Injection
Cefepime
Injection
49
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Cefepime
Injection
7/22/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
Fliptop Vial (NDC
0409-0220-01)
Available
Releasing product
consistently
Demand
increase for the
drug
7/22/2015
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
1 g vial (NDC 25021121-20)
Available
Demand
increase for the
drug
Cefepime
Injection
7/22/2015
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
2 g vial (NDC 25021122-50)
Product is on
allocation
Demand
increase for the
drug
Cefepime
Injection
7/22/2015
Currently
in Shortage
WG Critical Care
(Revised
01/28/2016)
1 g vial (NDC 445670240-10)
Available
Demand
increase for the
drug
Cefepime
Injection
7/22/2015
Currently
in Shortage
WG Critical Care
(Revised
01/28/2016)
2 g vial (NDC 445670241-10)
Available
Demand
increase for the
drug
2/17/2015
Currently
in Shortage
Sanofi-Aventis
(New 02/17/2015)
500mg Single Dose
Glass Fliptop Vial
(NDC 0039-0017-10)
Unavailable
Discontinuation
of the
manufacture of
the drug
2/17/2015
Currently
in Shortage
Sanofi-Aventis
(New 02/17/2015)
Fliptop Vial (NDC
0039-0018-10)
Inventory
available - under
allocation
Discontinuation
of the
manufacture of
the drug
2/17/2015
Currently
in Shortage
Sanofi-Aventis
(New 02/17/2015)
Fliptop Vial (NDC
0039-0019-10)
Unavailable
Discontinuation
of the
manufacture of
the drug
2/17/2015
Currently
in Shortage
Sanofi-Aventis
(New 02/17/2015)
10g Pharmacy Bulk
Package Glass Fliptop
Vial (NDC 0039-002001)
Inventory
available - under
allocation
Discontinuation
of the
manufacture of
the drug
2/17/2015
Currently
in Shortage
Sanofi-Aventis
(New 02/17/2015)
(NDC 0039-0023-25)
Inventory
available - under
allocation
Discontinuation
of the
manufacture of
the drug
Cefepime
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
50
Name
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotaxime
Sodium (Claforan)
Injection
Cefotetan
Disodium
Injection
Cefotetan
Disodium
Injection
Cefotetan
Disodium
Injection
Cefotetan
Disodium
Injection
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
2/17/2015
Currently
in Shortage
Sanofi-Aventis
(New 02/17/2015)
(NDC 0039-0024-25)
Unavailable
Discontinuation
of the
manufacture of
the drug
2/17/2015
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/17/2016)
500 mg/ 10 mL vial
(NDC 0143-9930-10)
Under allocation
Demand
increase for the
drug
2/17/2015
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/17/2016)
1 g/ 10 mL vial (NDC
0143-9931-25)
Under allocation
Demand
increase for the
drug
2/17/2015
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/17/2016)
2 g/ 10 mL vial (NDC
0143-9933-25)
Under allocation
Demand
increase for the
drug
2/17/2015
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/17/2016)
10 g/ 100 mL vial
(NDC 0143-9935-01)
Under allocation
Demand
increase for the
drug
1 gram/50 mL in
DUPLEX (NDC 002643173-11)
Due to demand
increase product
is on allocation to
contracted
customers based
on historical use.
Increased
demand for the
product.
Increased
demand for the
product.
8/14/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
8/14/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
2 gram/50 mL in
DUPLEX (NDC 002643175-11)
Due to demand
increase product
is on allocation to
contracted
customers based
on historical use.
8/14/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1 g SDV (NDC 633230385-10)
Available
Manufacturing
delay
8/14/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
2 g SDV (NDC 633230386-20)
Available
Manufacturing
delay
51
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
8/14/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
10 g PBP (NDC 633230396-61)
Backordered.
Next release
anticipated Q2 2016.
Manufacturing
delay
8/14/2014
Currently
in Shortage
Teligent (Revised
03/24/2016)
2 g SDV (NDC 52565053-10)
Product will be
launched at the
end of March
2016.
Other
Cefotetan
Disodium
Injection
8/14/2014
Currently
in Shortage
Teligent (Revised
03/24/2016)
1 g SDV (NDC 52565052-10)
Product will be
launched at the
end of March
2016.
Other
Chloramphenicol
Sodium Succinate
Injection
1/7/2014
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
EQ 1GM
base/vial(NDC 633230011-15)
Estimated
recovery: April
2016
Shortage of an
active
ingredient
Desmopressin
Acetate Injection
1/11/2016
Currently
in Shortage
Amring
Pharmaceuticals
(New 01/25/2016)
4 mcg/mL 10mL (NDC
69918-901-10)
Available
Other
Desmopressin
Acetate Injection
1/11/2016
Currently
in Shortage
Amring
Pharmaceuticals
(New 01/25/2016)
4 mcg/mL 1 mL (NDC
69918-899-01)
Available
Other
Desmopressin
Acetate Injection
1/11/2016
Currently
in Shortage
Ferring (New
01/12/2016)
4 mcg/mL 10 mL (NDC
55566-2300-0)
Product available
Other
Desmopressin
Acetate Injection
1/11/2016
Currently
in Shortage
Ferring (New
01/12/2016)
4 mcg/mL 1 mL (NDC
55566-2200-0)
Product available
Other
Desmopressin
Acetate Injection
1/11/2016
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
4 mcg/mL 1 mL (UNIAMP) (NDC 04092265-01)
Next delivery and
estimated
recovery TBD
Other
1/11/2016
Currently
in Shortage
Sun
Pharmaceutical
Industries Inc.
(New 01/14/2016)
4 mcg/mL 1 mL (NDC
62756-529-26)
Unavailable.
Estimated
availability: April
2016
Other
1/11/2016
Currently
in Shortage
Sun
Pharmaceutical
Industries Inc.
(New 01/14/2016)
4 mcg/mL 10 mL
multiple-dose vial
(NDC 62756-529-40)
Unavailable.
Estimated
availability: April
2016
Other
Name
Cefotetan
Disodium
Injection
Cefotetan
Disodium
Injection
Desmopressin
Acetate Injection
Desmopressin
Acetate Injection
52
Date First
Reported
Name
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
1/15/2013
1/15/2013
1/15/2013
1/15/2013
1/15/2013
1/15/2013
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
4 mg/mL 1 mL single
dose vial (NDC 005174901-25)
Unavailable- no
product available
for release. No
plan to
manufacture.
Other
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
4 mg/mL 5 mL
multiple dose vial
(NDC 00517-4905-25)
Unavailable- no
product available
for release. No
plan to
manufacture.
Other
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
4 mg/mL 30 mL
multiple dose vial
(NDC 00517-4930-25)
Unavailable- no
product available
for release. No
plan to
manufacture.
Other
4 mg per mL 1 mL
single dose vial (NDC
55150-237-01)
package of 25
Aurobindo
Pharma Ltd. has
recently launched
Dexamethasone
Sodium
Phosphate
Injection
Other
4 mg per mL 30 mL
multiple dose vial
(NDC 55150-239-30)
package of 25
Aurobindo
Pharma Ltd. has
recently launched
Dexamethasone
Sodium
Phosphate
Injection
Other
4 mg per mL 5 mL
multiple dose vial
(NDC 55150-238-05)
package of 25
Aurobindo
Pharma Ltd. has
recently launched
Dexamethasone
Sodium
Phosphate
Injection
Other
Currently
in Shortage
Currently
in Shortage
Currently
in Shortage
Aurobindo
Pharma (Revised
03/14/2016)
Aurobindo
Pharma (Revised
03/14/2016)
Aurobindo
Pharma (Revised
03/14/2016)
53
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Dexamethasone
Sodium
Phosphate
Injection
1/15/2013
Currently
in Shortage
BD Rx (Reverified
01/19/2016)
4 mg/mL single-use
Pre-filled syringe (NDC
76045-106-10)
Available
Other
1/15/2013
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
4 mg/mL 1 mL single
dose vial (NDC 633230165-01)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
20 mg/5 mL single
dose vial (NDC 633230165-05)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
120 mg/30 mL
multiple dose vial
(NDC 63323-0165-30)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
10 mg/mL single dose
vial (NDC 63323-050601)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
100 mg/10 mL
multiple-dose vial
(NDC 63323-0516-10)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
120mg/30mL
(4mg/mL) Pkg of 25
(NDC 67457-421-30)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
20mg/5mL (4mg/mL)
Pkg of 25 (NDC 67457422-54)
Available
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
4mg/mL Pkg of 25
(NDC 67457-423-12)
Unavailable.
Estimated
Recovery: TBD
Demand
increase for the
drug
1/15/2013
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
100mg/10mL
(10mg/mL) Pkg of 10
(NDC 67457-420-10)
Available
Demand
increase for the
drug
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
54
Name
Dexamethasone
Sodium
Phosphate
Injection
Dexamethasone
Sodium
Phosphate
Injection
Dextrose 5%
Injection Bags
Dextrose 5%
Injection Bags
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
1/15/2013
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
4 mg/mL Pkg of 25
NOVAPLUS (NDC
67457-419-01)
Available
Demand
increase for the
drug
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
1 mL vial 10 mg/mL
(NDC 0641-0367-25)
West-Ward
currently has a
temporary back
order situation.
Increase in
prooduct
demand due to
market supply
issues.
5% Dextrose 1000 mL
(NDC 0264-7510-00)
Continued
intermittent
interruptions in
supply allocating
to contracted
customers.
Demand
increase for the
drug
Demand
increase for the
drug
1/15/2013
5/19/2014
5/19/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
5% Dextrose 250 mL
(NDC 0264-7510-20)
Continued
intermittent
interruptions in
supply allocating
to contracted
customers.
150 mL VIAFLEX
container (NDC 03380017-01)
Unavailable.
Production is
planned to
resume in 1Q
2016.
Demand
increase for the
drug
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
250 mL VIAFLEX
Available
Demand
increase for the
drug
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
500 mL VIAFLEX
Available
Demand
increase for the
drug
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
1000 mL VIAFLEX
Available for
current
customers.
Demand
increase for the
drug
55
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
250 mL AVIVA nonPVC container (NDC
0338-6346-02)
Available for
current
customers.
Demand
increase for the
drug
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
500 mL AVIVA nonPVC container (NDC
0338-6346-03)
Available for
current
customers.
Demand
increase for the
drug
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 150 mL Flexible
Available
Other
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 250 mL ADDVantage Flexible
Available
Other
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 250 mL Flexible
Container (2 port)
(NDC 0409-7922-02)
Available
Other
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 250 mL VisIV
Flexible Container
(NDC 0409-7922-25)
Available
Other
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 500 mL Flexible
Available
Other
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 500 mL Flexible
Container (2 port)
(NDC 0409-7922-55)
Available
Other
Dextrose 5%
Injection Bags
5/19/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5% 1000 mL Flexible
Available
Other
Dextrose Injection
USP 70%
10/3/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
01/07/2016)
70% Dextrose 1000
mL glass bottle (NDC
0262-1290-55)
Allocating product
to current
customers.
Dextrose Injection
USP 70%
10/3/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
01/07/2016)
70% Dextrose 2000
mL bags (NDC 02647387-50)
Allocating product
to current
customers.
56
Date First
Reported
Name
Status
Company
Presentation
Availability
Shortage
Reason
2000 mL Viaflex
plastic container.
Pharmacy Bulk
Available for
current
customers.
Increase
demand of the
drug
Dextrose Injection
USP 70%
10/3/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Dextrose Injection
USP 70%
10/3/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
2 L Flexible Container
(NDC 0409-7120-07)
Available
Other
Dextrose Injection
USP 70%
10/3/2014
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
500 mL Flexible
Available
Other
4/18/2014
Currently
in Shortage
Actavis Inc.
(Revised
10/20/2015)
Disopyramide
phosphate 100 mg
capsules bottle of 100
(NDC 00591-5560-01)
Unavailable
4/18/2014
Currently
in Shortage
Actavis Inc.
(Revised
10/20/2015)
Disopyramide
phosphate 150 mg
(NDC 00591-5561-01)
Unavailable
4/18/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
12/23/2015)
Norpace CR 100 mg
capsules; bottle of
100's (NDC 00252732-31)
Available
Other manufacturing
delay
4/18/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
12/23/2015)
Norpace CR 100 mg
capsules; bottle of
500's (NDC 00252732-51)
Available
Other manufacturing
delay
4/18/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
12/23/2015)
Norpace CR 150 mg
capsules; bottle of
100s (NDC 0025-274231)
Available
Other manufacturing
delay
4/18/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
12/23/2015)
Norpace CR 150 mg
capsules; bottle of
500s (NDC 0025-274251)
Available
Other manufacturing
delay
4/18/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
12/23/2015)
Norpace 100mg
capsules; bottle of
100 (NDC 0025-275231)
Available
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
57
Name
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Disopyramide
Phosphate
(Norpace)
Capsules
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Date First
Reported
Status
Company
Presentation
Availability
4/18/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
12/23/2015)
Norpace 150mg
capsules; bottle of
100 (NDC 0025-276231)
Available
4/18/2014
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
Disopyramide
phosphate 100 mg
(NDC 00093-3127-01)
Available
4/18/2014
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
Disopyramide
phosphate 150 mg
(NDC 00093-3129-01)
Available
12/2/2011
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
2 mg/mL 5 mL Single
Dose Vial (NDC 63323883-05)
Available
Other
12/2/2011
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
2 mg/mL 10 mL Single
Available
Other
12/2/2011
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
2 mg/mL 25 mL Single
Available
Other
12/2/2011
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
2 mg/mL 100 mL
Multi Dose Vial (NDC
63323-101-61)
Available
Other
12/2/2011
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
10mg vials;
Lyophilized Powder
(NDC 67457-478-10)
Unavailable.
Estimated
Recovery: TBD
Demand
increase for the
drug
12/2/2011
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
50mg vials;
Lyophilized Powder
(NDC 67457-436-50)
Unavailable.
Estimated
Recovery: TBD
Demand
increase for the
drug
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin
10mg/5mL (2mg/mL)
5mL CYTOSAFE™
Single Use Vial 1's
(NDC 00069-3030-20)
Available
Other
12/2/2011
Shortage
Reason
58
Date First
Reported
Name
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin
20mg/10mL (2mg/mL)
10mL CYTOSAFE™
Single Use Vial 1's
(NDC 00069-3031-20)
Available
Other
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin
50mg/25mL (2mg/mL)
25mL CYTOSAFE™
Single Use Vial 1's
(NDC 00069-3032-20)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin
150mg/75mL
(2mg/mL) 75mL
CYTOSAFE™ Multi
Dose Vial 1's (NDC
00069-3033-20)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin
200mg/100mL Vial 1's
(NDC 00069-3034-20)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Available
Other
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin 50mg/25
mL (2mg/mL) 25 mL
Single Use Cytosafe®
Vial 1's for Novaplus®
(NDC 00069-4032-01)
Available
Other
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin 50mg/25
mL (2mg/mL) 25 mL
Vial 1's for
PREMIERPro™ Rx
(NDC 00069-4026-25)
Available
Other
12/2/2011
12/2/2011
12/2/2011
12/2/2011
Doxorubicin
10mg/5mL (2mg/mL)
5 mL Single Use
Cytosafe® Vial 1's for
Novaplus® (NDC
00069-4030-01)
Doxorubicin
10mg/5mL (2mg/mL)
5 mL Single Use
Cytosafe® Vial 1's for
PREMIERPro™ Rx
(NDC 00069-4004-05)
59
Date First
Reported
Name
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Doxorubicin 20mg/10
mL (2mg/mL) 10 mL
(NDC 00069-4031-01)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Available
Other
12/2/2011
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Available
Other
12/2/2011
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
2 mg per mL / 5mL
vial (NDC 25021-20705)
Available
Demand
increase for the
drug
12/2/2011
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
2 mg per mL / 25mL
vial (NDC 25021-20725)
Available
Demand
increase for the
drug
12/2/2011
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
2 mg per mL / 100mL
vial (NDC 25021-20751)
Available
Demand
increase for the
drug
12/2/2011
Doxorubicin 20mg/10
mL (2mg/mL) 10 mL
Vial 1's for
PREMIERPro™ Rx
(NDC 00069-4015-10)
Doxorubicin
150mg/75 mL
(2mg/mL) 75 mL
Multidose Cytosafe®
(NDC 00069-4033-01)
Doxorubicin
200mg/100 mL
(2mg/mL) 100 mL
(NDC 00069-4034-01)
Doxorubicin
200mg/100 mL
(2mg/mL) 100 mL
Vial 1's for
PREMIERPro™ Rx
(NDC 00069-4037-01)
60
Name
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Doxorubicin
(Adriamycin)
Injection
Epinephrine
Injection
Epinephrine
Injection
Epinephrine
Injection
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
12/2/2011
Currently
in Shortage
Sun
Pharmaceutical
Industries Inc.
(New 03/13/2015)
2 mg/mL 25 mL vial
(NDC 62756-0826-40)
Available
Other
12/2/2011
Currently
in Shortage
Sun
Pharmaceutical
Industries Inc.
(New 03/13/2015)
2 mg/mL 100 mL vial
(NDC 62756-0827-40)
Available
Other
12/2/2011
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
2 mg/mL 5 mL vial
(NDC 00703-5043-03)
Product is
currently
available.
Pending
12/2/2011
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
2 mg/mL 25 mL vial
(NDC 00703-5046-01)
Product is
currently
available.
Pending
12/2/2011
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
2 mg/mL 100 mL vial
(NDC 00703-5040-01)
Product is
currently
available.
Pending
4/27/2012
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
30 mL vial package of
5 (NDC 00517-113005)
Unavailable
Other
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
1 mg/mL 1 mL ampule
preservative free
sulfite-freepackage of
25 (NDC 00517-107125)
Unavailable Product on
backorder and will
be made available
as it is released.
Other
Currently
in Shortage
Amphastar
Pharmaceuticals
Inc./IMS
(Reverified
03/15/2016)
Epinephrine Inj. USP
1mg/mL 30mL vial
(NDC 76329-9061-00)
Product available
Demand
increase for the
drug
4/27/2012
4/27/2012
61
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
4/27/2012
Currently
in Shortage
Amphastar
Pharmaceuticals
Inc./IMS
(Reverified
03/15/2016)
1:10000 10mL LuerJet Prefilled
Syringe(NDC 763293316-1)(old NDC
0548-3316-00)
Amphastar will
regularly release
products.
Demand
increase for the
drug
Epinephrine
Injection
4/27/2012
Currently
in Shortage
BPI Labs LLC
(Revised
01/12/2016)
1 mg/mL 1 mL ampule
preservative-free
sulfite-free (NDC
54288-103-10)
Available
Epinephrine
Injection
4/27/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1 mg/mL 1 mL ampule
(NDC 0409-7241-01)
Available
Other
Epinephrine
Injection
4/27/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1:10000; 10 mL
Abboject-1 ½ “ needle
(NDC 0409-4921-34)
Next delivery:
April 2016;
Estimated
recovery: 2Q 2016
Other
Epinephrine
Injection
4/27/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1:10000; 10 mL
Abboject-3 ½ “ needle
(NDC 0409-4901-18)
Next delivery:
TBD; Estimated
recovery: TBD
Demand
increase for the
drug
4/27/2012
Currently
in Shortage
Par
Pharmaceutical
(Revised
01/12/2016)
Available
Available
4/27/2012
Currently
in Shortage
Par
Pharmaceutical
(Revised
01/12/2016)
Available
Available
12/18/2015
Currently
in Shortage
Aurobindo
Pharma
(Reverified
01/15/2016)
100-mL vials
containing 75 mg of
Eptifibatide (NDC
55150-218-99)
Check wholesalers
for availability.
Other
12/18/2015
Currently
in Shortage
Aurobindo
Pharma
(Reverified
01/15/2016)
100-mL vials
containing 200 mg of
Eptifibatide (NDC
55150-220-99)
Check wholesalers
for availability.
Other
12/18/2015
Currently
in Shortage
Aurobindo
Pharma
(Reverified
01/15/2016)
10-mL vials containing
20 mg of Eptifibatide
(NDC 55150-219-10)
Check wholesalers
for availability.
Other
Name
Epinephrine
Injection
Epinephrine
Injection
Epinephrine
Injection
Eptifibatide
(Integrilin)
Injection
Eptifibatide
(Integrilin)
Injection
Eptifibatide
(Integrilin)
Injection
Adrenalin®
(epinephrine injection
USP) 1 mg/mL 1 mL
vial pack of 25 (NDC
42023-159-25)
Adrenalin®
(epinephrine injection
USP) 1 mg/mL 30 mL
vial pack of 1 (NDC
42023-168-01)
62
Date First
Reported
Name
Eptifibatide
(Integrilin)
Injection
Eptifibatide
(Integrilin)
Injection
12/18/2015
12/18/2015
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Merck Sharp &
Dohme Corp.
(New 12/18/2015)
10-mL vials containing
20 mg of Eptifibatide
(NDC 0085-1177-01)
Limited inventory
is available.
Inventory will be
re-supplied
periodically.
Other
Currently
in Shortage
Merck Sharp &
Dohme Corp.
(New 12/18/2015)
100-mL vials
containing 75 mg of
Eptifibatide (NDC
0085-1136-01)
Limited inventory
is available.
Inventory will be
re-supplied
periodically.
Other
Limited inventory
is available.
Inventory will be
re-supplied
periodically.
Other
Eptifibatide
(Integrilin)
Injection
12/18/2015
Currently
in Shortage
Merck Sharp &
Dohme Corp.
(New 12/18/2015)
100-mL vials
containing 200 mg of
Eptifibatide (NDC
0085-1177-02)
Ethiodized Oil
(Lipiodol)
Injection
6/24/2015
Currently
in Shortage
Guerbet LLC (New
06/24/2015)
Box of one 10 mL
ampoule (NDC 676841901-1)
Unavailable
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
2 mL ampule 10 pack
(NDC 17478-0030-02)
Readily Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
2 mL ampule; 25 pack
(NDC 17478-0030-25)
Readily Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
5 mL ampule 10 pack
(NDC 17478-0030-05)
Readily Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
20 mL ampule (NDC
17478-0030-20)
Readily Available
Other
63
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
5 mL ampule 25 pack
(NDC 17478-0030-55)
Readily Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 2 mL
Carpuject (NDC 04091276-32)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 2 mL
amp (NDC 0409-909332)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 5 mL
amp (NDC 0409-909335)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 20 mL
amp (NDC 0409-909338)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 2 mL vial
(NDC 0409-9094-22)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 5 mL vial
(NDC 0409-9094-25)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 10 mL
vial (NDC 0409-909428)
Available
Other
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 20 mL
vial (NDC 0409-909431)
Available
Releasing product
consistently
Demand
increase for the
drug
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
0.05 mg/mL; 50 mL
vial (NDC 0409-909461)
Available
Releasing product
consistently
Demand
increase for the
drug
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 2 mL
ampul (NDC 06416024-10)
Inventory
available
Demand
increase for the
drug
Name
64
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 5 mL
ampul (NDC 06416025-10)
Inventory
available
Demand
increase for the
drug
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 20 mL
ampul (NDC 06416026-05)
This presentation
is temporarily on
backorder.
Demand
increase for the
drug
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 2 mL
vial(NDC 0641-602725)
This presentation
is temporarily on
backorder.
Demand
increase for the
drug
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 5 mL
vial(NDC 0641-602825)
This presentation
is temporarily on
backorder.
Regulatory
delay
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 20 mL vial
(NDC 0641-6029-25)
Inventory
available
Demand
increase for the
drug
Fentanyl Citrate
(Sublimaze)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 50 mL
vial(NDC 0641-603001)
Inventory
available
Demand
increase for the
drug
Fomepizole
Injection
3/18/2015
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
1g/mL 1.5 ml vial
(NDC 39822-0710-1;
X-Gen label)
Available for NDC
39822-0710-1.
Shortage of an
active
ingredient.
3/18/2015
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
1g/mL 1.5 ml vial
(NDC 67457-211-02)
Available
Demand
increase for the
drug
1g/mL 1.5 ml vial 1s
(NDC 0781-3182-73;
Sandoz label)
Currently
unavailable.
Estimated
recovery is TBD.
Requirements
related to
complying with
good
manufacturing
practices.
Name
Fomepizole
Injection
Fomepizole
Injection
3/18/2015
Currently
in Shortage
Navinta LLC (New
03/18/2015)
65
Date First
Reported
Name
Status
Company
Presentation
Availability
Shortage
Reason
Requirements
related to
complying with
good
manufacturing
practices.
Fomepizole
Injection
3/18/2015
Currently
in Shortage
Navinta LLC (New
03/18/2015)
1g/mL 1.5 ml vial 4s
(NDC 0781-3182-84;
Sandoz label)
Currently
unavailable.
Estimated
recovery is TBD.
Gemifloxacin
Mesylate (Factive)
Tablets
5/27/2015
Currently
in Shortage
LG Life Sciences
Ltd. (Reverified
03/03/2016)
320mg 7 Tablets in 1
Blister Pack (NDC
44004-321-07)
Estimated
recovery to be
determined.
Other
Gemifloxacin
Mesylate (Factive)
Tablets
5/27/2015
Currently
in Shortage
LG Life Sciences
Ltd. (Reverified
03/03/2016)
320mg 5 Tablets in 1
Blister Pack (NDC
44004-321-05)
Estimated
recovery to be
determined.
Other
5/22/2015
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
250 mg/250 mg per
vial single dose vial
sterile powder (NDC
63323-349-25)
Backordered.
Next release
anticipated April
2016.
Demand
increase for the
drug
5/22/2015
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
500 mg/500 mg per
vial single dose vial
sterile powder (NDC
63323-322-25)
Backordered.
Next release
anticipated April
2016.
Demand
increase for the
drug
5/22/2015
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
500 mg/500 mg Single
Dose Glass Fliptop Vial
(NDC 0409-3507-01)
Next delivery: Mid
March 2016;
Estimated
recovery: 1Q 2016
Other
5/22/2015
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
250 mg/250 mg Single
(NDC 0409-3508-01)
Next delivery: Mid
March 2016;
Estimated
recovery: 1Q 2016
Other
Imipenem and
Cilastatin for
Injection USP
Imipenem and
Cilastatin for
Injection USP
Imipenem and
Cilastatin for
Injection USP
Imipenem and
Cilastatin for
Injection USP
Imipenem and
Cilastatin for
Injection USP
Imipenem and
Cilastatin for
Injection USP
5/22/2015
5/22/2015
Currently
in Shortage
Merck Sharp &
Dohme Corp.
(Revised
08/03/2015)
Currently
in Shortage
Merck Sharp &
Dohme Corp.
(Revised
08/03/2015)
250 mg imipenem
equivalent and 250
mg cilastatin
equivalent and 10 mg
sodium bicarbonate
as a buffer in trays of
25 vials (NDC 00063514-58)
500 mg imipenem
equivalent and 500
mg cilastatin
equivalent and 20 mg
sodium bicarbonate
as a buffer in trays of
25 vials (NDC 0006-
Demand
increase for the
drug
Limited inventory
is available.
Inventory will be
resupplied
periodically.
Demand
increase for the
drug
66
Date First
Reported
Name
Status
Company
Presentation
Availability
Shortage
Reason
Not available.
Estimated
recovery TBD
Shortage of an
active
ingredient.
Product currently
available
Requirements
related to
complying with
good
manufacturing
practices.
3516-59)
Indigotindisulfona
te Sodium (Indigo
Carmine)
Injection
L-Cysteine
Hydrochloride
Injection
6/20/2014
1/9/2015
Currently
in Shortage
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
11/13/2015)
Sandoz
(Reverified
03/14/2016)
5 mL ampoule (NDC
17478-0508-01)
50 mg/mL 10x10 mL
vial (NDC 66759-00402)
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
50 mg/mL 5x50 mL
vial (NDC 66758-00502)
Product currently
available
Requirements
related to
complying with
good
manufacturing
practices
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
200 mg SDV (NDC
63323-710-50)
Available
Demand
increase for the
drug
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
500 mg SDV (NDC
63323-711-00)
Product available
on allocation.
Manufacturing
delay
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
50 mg vial (NDC
25021-813-10)
Backordered
Demand
increase for the
drug
L-Cysteine
Hydrochloride
Injection
1/9/2015
67
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
100mg vial (NDC
25021-814-30)
Available
Demand
increase for the
drug
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
200mg vial (NDC
25021-815-30)
Available
Demand
increase for the
drug
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
350mg vial (NDC
25021-816-30)
Available
Demand
increase for the
drug
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
100mg/vial 20mL
(NDC 0703-5140-01)
Product is
currently
available.
Regulatory
delay
Leucovorin
Calcium
Lyophilized
Powder for
Injection
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
350mg/vial 30mL
(NDC 00703-5145-01)
Product is
currently
available.
Regulatory
delay
Leuprolide
Acetate Injection
Currently
in Shortage
Caraco (New )
1 mg/0.2 ml (NDC
41616-0936-40)
On intermittent
backorder.
Demand
increase for the
drug
Leuprolide
Acetate Injection
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
1 mg/0.2 ml (NDC
0781-4003-32)
Product currently
available
Shortage of an
active
ingredient
Leuprolide
Acetate Injection
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
1 mg/0.2 ml (NDC
00703-4014-18)
Teva expects to
have product
available Q1'18
Regulatory
delay
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
1% 50 mL vial package
of 25 (NDC 005170625-25)
Unavailable-No
product available
for release. No
plan to
manufacture.
Discontinuation
of the
manufacture of
the drug
Name
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
68
Date First
Reported
Name
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Status
Company
Presentation
Availability
Shortage
Reason
2/22/2012
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
2% 50 mL vial package
of 25 (NDC 005170626-25)
Unavailable-No
product available
for release. No
plan to
manufacture.
Discontinuation
of the
manufacture of
the drug
2/22/2012
Currently
in Shortage
Amphastar
Pharmaceuticals
Inc./IMS (Revised
03/15/2016)
2% 5mL Luer-Jet
Prefilled Syringe (NDC
76329-3390-1)(old
NDC 0548-3390-00)
Product available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
1% 2 mL Ampoule
(NDC 55150-158-22)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
1% 5 mL Ampoule
(NDC 55150-159-74)
Available
demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
2% 2 mL Ampoule
(NDC 55150-160-72)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
1% 2 mL Single Dose
Vial (NDC 55150-16102)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
1% 5 mL Single Dose
Vial (NDC 55150-16330)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
1% 30 mL Single Dose
Vial (NDC 55150-16330)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
2% 2 mL Single Dose
Vial (NDC 55150-16402)
Available
Demand
increase for the
drug
69
Name
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
2/22/2012
Currently
in Shortage
Aurobindo
Pharma
(Reverified
03/18/2014)
2% 5 mL Single Dose
Vial (NDC 55150-16505)
Available
Demand
increase for the
drug
Available
Demand
increase for the
drug
Available
Demand
increase for the
drug
Lidocaine 1.5%
Xylocaine 1.5% - MPF
injection 15 mg/mL 10
mL ampule (NDC
63323-0493-97)
Lidocaine 1.5%
mL ampule (NDC
63323-0493-91)
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Lidocaine 2%
Lidocaine 2% injection
20 mg/mL 2 mL vial
(NDC 63323-0202-02)
Backordered. No
release date
available at this
time.
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
20 mg/mL 5 mL SD
Tear Top vial
preservative-free
(NDC 63323-0208-05)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 2% injection
20 mg/mL 10 mL vial
(NDC 63323-0486-17)
Backordered. No
release date
available at this
time.
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
20 mg/mL 20 mL vial
(NDC 63323-0486-27)
Backordered.
Next release
anticipated April
2016.
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
20 mg/mL 50 mL vial
(NDC 63323-0486-57)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
20 mg/mL 10 mL vial
(NDC 63323-048610)discontinued
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Demand
increase for the
drug
70
Date First
Reported
Name
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Company
Presentation
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
NDC discontinued 20
mg/mL 20 mL vial
(NDC 63323-0486-20)NDC discontinued
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
20 mg/mL 50 mL vial
(NDC 63323-0486-50)NDC discontinued
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 2% - MPF
mL vial (NDC 633230495-27)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 2% - MPF
mL vial (NDC 633230495-07)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 2% - MPF
mL ampule (NDC
63323-0496-97)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Lidocaine 0.5%
Xylocaine 0.5%
mL vial (NDC 633230484-57)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
injection APP 5
mg/mL 50 mL vial
(NDC 63323-0491-57)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Lidocaine 1%
10 mg/mL 2 mL vial
(NDC 63323-0201-02)
Backordered. No
release date
available at this
time.
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Lidocaine 1%
10 mg/mL 10 mL vial
(NDC 63323-0201-10)
Backordered.
Next release date
not available at
this time.
Demand
increase for the
drug
Availability
Shortage
Reason
Status
71
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
10 mg/mL 20 mL vial
(NDC 63323-0485-27)
Backordered.
Next release
anticipated March
2016.
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
10 mg/mL 50 mL vial
(NDC 63323-0485-57
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 1% - MPF
mL vial (NDC 633230492-27)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 1% - MPF
mL glass ampule (NDC
63323-0492-80)
Backordered. No
release
expectations at
this time.
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 1% - MPF
mL glass ampule (NDC
63323-0492-89)
Backordered. No
release
expectations at
this time.
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 1% - MPF
mL vial (NDC 633230492-57)
Available
Demand
increase for the
drug
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 1% - MPF
mL vial (NDC 633230492-37)
Backordered.
Next release
anticipated April
2016.
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
Xylocaine 1% - MPF
mL vial sterile pack
(NDC 63323-0492-31)
Available
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.5% w/EPI 1:100000;
1.8 mL Carpule (NDC
0409-0996-01)
Estimated delivery
and recovery:
2016
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.5% w/EPI 1:200000;
50 mL vial (NDC 04093177-01)
Available
Other
Name
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
72
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1% w/EPI 1:100000;
20 mL vial (NDC 04093178-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1% w/EPI 1:100000;
30 mL vial (NDC 04093178-02)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1% w/EPI 1:100000;
50 mL vial (NDC 04093178-03)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1.5% w/EPI 1:200000;
5 mL amp (NDC 04091209-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1.5% w/EPI 1:200000;
30 mL amp (NDC
0409-3181-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2% w/EPI 1:100000;
20 mL vial (NDC 04093182-01)
Available
releasing product
consistently
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2% w/EPI 1:100000;
30 mL vial (NDC 04093182-02)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2% w/EPI 1:100000;
50 mL vial (NDC 04093182-03)
Available
releasing product
consistently
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2% w/EPI 1:200000;
20 mL vial (NDC 04093183-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2% w Epi 1:50000;
1.8mL syringe (NDC
0409-7263-01)
Estimated delivery
and recovery TBD
Other
73
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 5mL Ansyr Syringe
(NDC 0409-9137-05)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1.5%; 20mL Sterile
Pack Amp (NDC 04094056-01)
Discontinued
Discontinuation
of the
manufacture of
the drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 2 mL amp (NDC
0409-4713-32)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 20 mL vial (NDC
0409-4276-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 30 mL vial (NDC
0409-4279-02)
Available
releasing product
consistently
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 50 mL vial (NDC
0409-4276-02)
Available
releasing product
consistently
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 30 mL Sterile Pack
vial (NDC 0409-427001)
Next delivery &
Estimated
recovery TBD
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2%; 2 mL amp (NDC
0409-4282-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2%; 10 mL amp (NDC
0409-4282-02)
Available
Other
74
Date First
Reported
Name
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 5 mL Abboject
syringe (NDC 04094904-34)
Next delivery:
Early May 2016;
Estimated
recovery: 2Q
2016.
Other
2%; 5 mL Abboject
syringe (NDC 04094903-34)
Next delivery:
Late April 2016;
Estimated
recovery: 2Q
2016.
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2%; 5 mL vial (NDC
0409-2066-05)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2%; 20 mL vial (NDC
0409-4277-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2%; 50 mL vial (NDC
0409-4277-02)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
4%; 5 mL amp (NDC
0409-4283-01)
Available
Other
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.4% in 5% Dex;
500mL flex (NDC
0409-7931-24)
Discontinued
Discontinuation
of the
manufacturer
of the drug
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.4% in 5% Dex;
250mL flex (NDC
0409-7931-32)
Discontinued
Discontinuation
of the
manufacturer
of the drug
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.8% in 5% Dex;
250mL flex (NDC
0409-7939-32)
Discontinued
Discontinuation
of the
manufacturer
of the drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
Lidocaine
Hydrochloride
(Xylocaine)
Injection
75
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2%; 5mL Ansyr syringe
(NDC 0409-1323-05)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.5%; 50 mL FT vial
(NDC 0409-4275-01)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
5% w/7.5% Dex; 2mL
amp (NDC 0409-471201)
Available
Other
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
0.5%; 50 mL TT vial
(NDC 0409-4278-01)
Available
Releasing product
consistently
Demand
increase for the
drug
Lidocaine
Hydrochloride
(Xylocaine)
Injection
2/22/2012
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1%; 5 mL amp (NDC
0409-4713-02)
Available
Releasing product
consistently
Demand
increase for the
drug
LifeCare PCA™
Sterile Empty Vial
and Injector
12/14/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
LifeCare PCA Pump
Accessory
Next delivery and
estimated
recovery TBD
Other
Liotrix (Thyrolar)
Tablets
Currently
in Shortage
Forest
Laboratories Inc.
(Reverified
08/11/2015)
Thyrolar-1/4 (NDC
0456-0040-01)
Product currently
unavailable;
estimated
duration: 1 year
Shortage of an
active
ingredient
Liotrix (Thyrolar)
Tablets
Currently
in Shortage
Forest
Laboratories Inc.
(Reverified
08/11/2015)
Thyrolar-1/2 (NDC
0456-0045-01)
Product currently
unavailable;
estimated
duration: 1 year
Shortage of an
active
ingredient
Liotrix (Thyrolar)
Tablets
Currently
in Shortage
Forest
Laboratories Inc.
(Reverified
08/11/2015)
Thyrolar-1 (NDC 04560050-01)
Product currently
unavailable;
estimated
duration: 1 year
Shortage of an
active
ingredient
Liotrix (Thyrolar)
Tablets
Currently
in Shortage
Forest
Laboratories Inc.
(Reverified
08/11/2015)
Thyrolar-2 (NDC 04560055-01)
Product currently
unavailable;
estimated
duration: 1 year
Shortage of an
active
ingredient
76
Date First
Reported
Name
Liotrix (Thyrolar)
Tablets
Mecasermin
[rDNA origin]
(Increlex)
Injection
Meropenem for
Injection USP
4/26/2012
8/25/2015
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Forest
Laboratories Inc.
(Reverified
08/11/2015)
Thyrolar-3 (NDC 04560060-01)
Product currently
unavailable;
estimated
duration: 1 year
Shortage of an
active
ingredient
Currently
in Shortage
Ipsen
Biopharmaceutica
ls Inc. (Revised
10/19/2015)
INCRELEX(mecasermi
n [rDNA origin]
injection) 10
mg/mL(NDC-150541040-5)
Limited supply
available.
Shortage of an
active
ingredient
500 mg/20mL (NDC
0310-0325-20)
Limited stock
available in
September;
shortage duration
4Q 2015
Demand
increase for the
drug
Demand
increase for the
drug
Currently
in Shortage
AstraZeneca (New
09/09/2015)
Meropenem for
Injection USP
8/25/2015
Currently
in Shortage
AstraZeneca (New
09/09/2015)
1 gm/30mL (NDC
0310-0321-30)
Limited stock
available in
September;
shortage duration
4Q 2015
Meropenem for
Injection USP
8/25/2015
Currently
in Shortage
B. Braun Medical
Inc. (New
12/18/2015)
500 mg Meropenem
50 mL (NDC 02643183-11)
Product available
under allocation
Demand
increase for the
drug
Meropenem for
Injection USP
8/25/2015
Currently
in Shortage
B. Braun Medical
Inc. (New
12/18/2015)
1 gram Meropenem
50 mL (NDC 02643185-11)
Product available
under allocation
Demand
increase for the
drug
8/25/2015
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
500 mg SDV (NDC
63323-507-20)
Available
Demand
increase for the
drug
Meropenem for
Injection USP
8/25/2015
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1 g SDV (NDC 63323508-30)
Available
Demand
increase for the
drug
Meropenem for
Injection USP
8/25/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
500 mg Single Dose
Glass Fliptop Vial
(NDC 0409-3505-01)
Available
Other
Meropenem for
Injection USP
8/25/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
Fliptop Vial (NDC
0409-3506-01)
Available
Other
Meropenem for
Injection USP
77
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Methyldopate
Hydrochloride
Injection
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
50 mg/mL 5 mL vial
10s (NDC 00517-890510)
Unavailable-No
product available
for release. No
plan to
manufacture
Shortage of an
active
ingredient
Methylprednisolo
ne Sodium
Succinate for
Injection USP
3/10/2016
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
40 mg Single Dose Vial
(NDC 63323-255-03)
Backordered.
Next release
anticipated late
April 2016.
Demand
increase for the
drug
3/10/2016
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
125 mg Single Dose
Vial (NDC 63323-25803)
Backordered.
Next release
anticipated late
April 2016.
Demand
increase for the
drug
3/10/2016
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1 g Single Dose Vial
(NDC 63323-265-30)
Available
Demand
increase for the
drug
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 40 mg
1 mL ACT-O-VIAL®
(NDC 0009-0039-28)
Weekly shipments
with full recovery
projected
beginning July
2016
Manufacturing
delay
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 125
mg 2 mL ACT-O-VIAL®
(NDC 0009-0047-22)
Weekly shipments
with full recovery
projected
beginning July
2016
Manufacturing
delay
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 500
mg 4 mL ACT-O-VIAL®
(NDC 0009-0003-02)
Available
Name
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
3/10/2016
3/10/2016
3/10/2016
Currently
in Shortage
Currently
in Shortage
Currently
in Shortage
78
Date First
Reported
Name
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Methylprednisolo
ne Sodium
Succinate for
Injection USP
3/10/2016
3/10/2016
3/10/2016
3/10/2016
3/10/2016
Status
Currently
in Shortage
Currently
in Shortage
Currently
in Shortage
Currently
in Shortage
Currently
in Shortage
Company
Presentation
Availability
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 1 gm 8
mL ACT-O-VIAL® (NDC
0009-0758-01)
Available
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 1 gm 8
mL ACT-O-VIAL® (NDC
0009-0018-20)
Available
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 1 gm
16 mL Vial (NDC 00090698-01)
Available
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection Rx 2 gm
Vial w/Diluent (NDC
0009-0796-01)
Available
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection for
NovaPlus® Rx 40 mg 1
mL ACT-O-VIAL (NDC
0009-0039-32)
Available
Shortage
Reason
79
Date First
Reported
Name
Status
Company
Presentation
Availability
Available
Shortage
Reason
3/10/2016
Currently
in Shortage
Pfizer
Pharmaceuticals
(New 03/10/2016)
Solu-Medrol®
(methylprednisolone
sodium succinate
USP) Sterile Powder
for Injection for
NovaPlus® Rx 125 mg
2 mL ACT-O-VIAL®
(NDC 0009-0047-26)
12/14/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
1 mg/mL; 30 mg/30
mL PCA Glass Vial
(without injector)
(NDC 0409-2029-02)
Next delivery and
estimated
recovery: No ETA
at this time
Other
12/14/2015
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
5 mg/mL; 150 mg/30
mL PCA Glass Vial
(without injector)
(NDC 0409-6028-04)
Next delivery and
estimated
recovery: No ETA
at this time
Other
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
INFUVITE Pediatric
Multiple Vitamins for
Injection. Single Dose
package. (NDC 546435646-1)
Available
Demand
increase for
drug
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Available
Demand
increase for
drug
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Available
Demand
increase for
drug
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Available
Demand
increase for
drug
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
MVI-12 Adult; 10 mL
vial (NDC 0409-42381)
TBD
Other
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
MVI-12 Adult; 2x50
mL PBP (NDC 0409423-83)
Next delivery and
estimated
recovery: TBD
Other
Methylprednisolo
ne Sodium
Succinate for
Injection USP
Morphine Sulfate
Injection USP CII
(PreservativeFree)(For PCA Use
Only)
Morphine Sulfate
Injection USP CII
(PreservativeFree)(For PCA Use
Only)
Multi-Vitamin
Infusion (Adult
and Pediatric)
INFUVITE Adult
Injection. Single dose
package. (NDC 546435649-1)
INFUVITE Adult
Injection. Bulk
package. (NDC 546435650-2)
INFUVITE Pediatric
Injection. Bulk
package. (NDC 546435647-0)
80
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
MVI Adult; 10 mL vial
(NDC 0409-422-81)
TBD
Other
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
MVI Adult; 2x5 mL
(NDC 0409-422-82)
Available
Other
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
MVI Adult 2x50 mL
PBP (NDC 0409-42283)
Available
Other
Multi-Vitamin
Infusion (Adult
and Pediatric)
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
MVI Pediatric; 5 mL
vial (NDC 0409-42153)
Available
Other
No supply
currently
available.Resupply
expected no
earlier than
March 2016
Requirements
related to
complying with
good
manufacturing
practices
Name
Mupirocin
Calcium Nasal
Ointment
Nimodipine
(Nymalize) Oral
Solution
Nimodipine
(Nymalize) Oral
Solution
Peritoneal Dialysis
Solutions
Peritoneal Dialysis
Solutions
10/14/2015
Currently
in Shortage
GlaxoSmithKline
(New 10/14/2015)
2% Nasal Ointment1
gram tubePackage of
10(NDC#
0029152611)
6/2/2015
Currently
in Shortage
Arbor
Pharmaceuticals
(Revised
11/03/2015)
60mg/20mL 20 mL
unit-dose cups (NDC
24338-200-20)
Available
Shortage of an
active
ingredient
6/2/2015
Currently
in Shortage
Arbor
Pharmaceuticals
(Revised
11/03/2015)
60mg/20mL 16 oz
bottles (NDC 24338200-16)
Available
Shortage of an
active
ingredient
Available to
current customers
by allocation.
Please see link.
Demand
increase for the
drug
Available. Please
see link.
Demand
increase for the
drug
8/8/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
8/8/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Peritoneal Dialysis
Solutions for
Automated Peritoneal
Dialysis (APD) therapy
(Dianeal and
Extraneal)
Peritoneal Dialysis
Solutions for
Continuous
Ambulatory
Peritoneal Dialysis
(CAPD) therapy
(Dianeal and
Extraneal)
81
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Peritoneal Dialysis
Solutions
8/8/2014
Currently
in Shortage
Fresenius Medical
Care North
America (New
08/08/2014)
Peritoneal Dialysis
Solutions (Delflex and
Stay Safe)
Available
Other
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Apotex Corp.
(Reverified
03/25/2016)
2.25 gm/vial (10 Vials)
(NDC 60505-0686-4)
On backorder
Demand
increase in the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Apotex Corp.
(Reverified
03/25/2016)
(NDC 60505-0687-4)
On backorder
Demand
increase in the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Apotex Corp.
(Reverified
03/25/2016)
(NDC 60505-0688-4)
On backorder
Demand
increase in the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Apotex Corp.
(Reverified
03/25/2016)
40.5 gm/vial (NDC
60505-0773-0)
On backorder
Demand
increase in the
drug
2.25 g SDV Cartons of
10 (NDC 55150-11930)
On intermittent
back order; the
company is
releasing product
as it becomes
available.
Other
3.375 g SDV Cartons
of 10 (NDC 55150120-30)
On intermittent
back order; the
company is
releasing product
as it becomes
available.
Other
4.5 g SDV Cartons of
10 (NDC 55150-12150)
On intermittent
back order; the
company is
releasing product
as it becomes
available.
Other
2.25 g single-dose vial
(NDC 63323-309-20)
Backordered.
Increasing
manufacturing
and shipping upon
release.
Demand
increase for the
drug
Name
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
4/2/2014
4/2/2014
4/2/2014
Currently
in Shortage
Currently
in Shortage
Aurobindo
Pharma (Revised
01/20/2015)
Aurobindo
Pharma (Revised
01/20/2015)
Currently
in Shortage
Aurobindo
Pharma (Revised
01/20/2015)
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
82
Date First
Reported
Name
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
4/2/2014
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
3.375 g single-dose
vial (NDC 63323-30030)
Backordered.
Increasing
manufacturing
and shipping upon
release.
Demand
increase for the
drug
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
4.5 g single-dose vial
(NDC 63323-320-50)
Backordered.
Increasing
manufacturing
and shipping upon
release.
Demand
increase for the
drug
40.5 g PBP (NDC
63323-304-74)
Backordered.
Increasing
manufacturing
and shipping upon
release.
Demand
increase for the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2.25 g Add-Vantage
Vial (NDC 0409-337402)
Available
releasing product
consistently
Demand
increase for the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
3.375 g; Add-Vantage
Vial (NDC 0409-337813)
Available
releasing product
consistently
Demand
increase for the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
4.5 g; Add-Vantage
Vial (NDC 0409-337904)
Available
releasing product
consistently
Demand
increase for the
drug
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2.25 g; Vial (NDC
0409-3383-02)
Next delivery:
Early May 2016
and Estimated
recovery Late 3Q
2016
Demand
increase for the
drug
3.375 g; Vial (NDC
0409-3385-13)
Next delivery:
Early April 2016
and Estimated
recovery Late 3Q
2016
Demand
increase for the
drug
4.5 g; Vial (NDC 04093390-04)
Available
releasing product
consistently
Demand
increase for the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
83
Name
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Piperacillin and
Tazobactam
(Zosyn) Injection
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
4/2/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
3.375 g Pkg of 10
(NDC 67457-522-37)
Available
Demand
increase for the
drug
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 2.25/50mL
Frozen Bag 24's (NDC
0206-8860-02)
Available
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 3.375/50mL
Frozen Bags 24's (NDC
0206-8861-02)
Available
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 4.5/100mL
Frozen Bags 12's (NDC
0206-8862-02)
Available
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 2.25g 10's (NDC
0206-8852-16)
Unavailable
Manufacturing
Delays
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 3.375g 10's
(NDC 0206-8854-16)
Unavailable
Manufacturing
Delays
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 4.5g 10's (NDC
0206-8855-16)
Unavailable
Manufacturing
Delays
4/2/2014
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Zosyn 40.5g Pharm
Bulk 1's (NDC 02068859-10)
Unavailable
Sourcing
Change
4/2/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
2.25mg 30mL vial
(NDC 25021-164-30)
Backordered
Demand
increase for the
drug
4/2/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
3.375g 30mL vial (NDC
25021-165-30)
Backordered
Demand
increase for the
drug
Increased
market
demand and
capacity
constraint
Increased
market
demand and
capacity
constraint
Increased
market
demand and
capacity
constraint
84
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
4.5g 48mL vial (NDC
25021-166-48)
Backordered
Demand
increase for the
drug
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
4.5g (NDC 007813114-95)
No more supply
from this vendor
Other
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
3.75g (NDC 007813113-95)
No more supply
from this vendor
Other
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
2025g (NDC 007813110-95)
Stock sold out. No
more supply from
this vendor.
Other
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
3.75g (NDC 007813350-95)
Supply in house.
Other
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
WG Critical Care
(Revised
01/28/2016)
2.25g (NDC 445670801-10)
Product on
backorder
Increased
demand for the
product.
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
WG Critical Care
(Revised
01/28/2016)
3.375g (NDC 445670802-10)
Product on
backorder
Increased
demand for the
product.
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
WG Critical Care
(Revised
01/28/2016)
4.5g (NDC 445670803-10)
Product on
backorder
Increased
demand for the
product.
Piperacillin and
Tazobactam
(Zosyn) Injection
4/2/2014
Currently
in Shortage
WG Critical Care
(Revised
01/28/2016)
40.5g (NDC 445670804-01)
Product on
backorder
Increased
demand for the
product.
Currently
in Shortage
Exela Pharma
Sciences LLC (New
03/01/2016)
2 mEq/mL; 40 mEq/20
mL Single Dose Fliptop
Vial (NDC 517542001-4)
Available; product
will be released
regularly and
manufacturing is
on-going.
Demand
increase for the
drug
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
2 mEq/mL; 100
mEq/50 mL Pharmacy
Bulk Package Glass
Fliptop Vial (NDC
0409-3294-51)
Available
releasing product
consistently
Demand
increase for the
drug
Name
Potassium
Acetate Injection
USP
Potassium
Acetate Injection
USP
2/3/2016
2/3/2016
85
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Potassium
Acetate Injection
USP
2/3/2016
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
2 mEq/mL; 40 mEq/20
mL Single Dose Plastic
Fliptop Vial (NDC
0409-8183-01)
Available
releasing product
consistently
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
B. Braun Medical
Inc. (Revised
01/07/2016)
KCl 2 mEq/mL 250 mL
bulk package (NDC
00264-1940-20)
Allocating product
to current
customers
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
10 mEq/100 mL in
sterile water (NDC
00338-0709-48)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/100 mL in
sterile water (NDC
00338-0705-48)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
40 mEq/100 mL in
sterile water (NDC
00338-0703-48)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/50 mL in
sterile water (NDC
00338-0703-41)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
10 mEq/50 mL in
sterile water (NDC
00338-0705-41)
Available
Demand
increase for the
drug
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/1000 mL in
lactated ringers and
dextrose 5% (NDC
00338-0811-04)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/1000 mL in
5% dextrose and 0.9%
sodium chloride (NDC
00338-0803-04)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/1000 mL in
0.9% sodium chloride
(NDC 00338-0691-04)
Available
Name
Potassium
Chloride Injection
86
Date First
Reported
Name
Status
Company
Presentation
Availability
40 mEq/1000 mL in
5% dextrose and
0.45% sodium
chloride (NDC 003380675-04)
Available
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/1000 mL in
5% dextrose (NDC
00338-0683-04)
Available
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
40 mEq/1000 mL in
0.9% sodium chloride
(NDC 00338-0695-04)
Available
20 mEq/1000 mL in
5% dextrose and
0.45% sodium
20 mEq/L in 5%
dextrose and 0.45%
sodium chloride 500
mL (NDC 00338-067103)
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/1000 mL in
0.45% sodium
Available
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
40 mEq/1000 mL in
00338-0807-04)
Available
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/L in 5%
dextrose and 0.2%
sodium chloride 500
mL (NDC 00338-066303)
Available
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
20 mEq/1000 mL in
00338-0663-04)
Available
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
10 mEq/1000 mL in
5% dextrose and
0.45% sodium
Available
Potassium
Chloride Injection
Potassium
Chloride Injection
Potassium
Chloride Injection
Potassium
Chloride Injection
Potassium
Chloride Injection
5/15/2012
Shortage
Reason
Available
Available
87
Date First
Reported
Name
Status
Company
Presentation
Availability
30 mEq/1000 mL in
5% dextrose and
0.45% sodium
Available
Shortage
Reason
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
2 mEq/mL 5 mL vials
(NDC 63323-0965-05)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
2 mEq/mL 10 mL vials
(NDC 63323-0965-10)
Backordered.
Next release
anticipated May
2016.
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
(NDC 63323-0965-15)
Unavailable
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
(NDC 63323-0965-20)
Backordered.
Next release
anticipated March
2016.
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
(NDC 63323-0967-30)
Available
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
2 mEq/mL; 250 mL
bottle (NDC 04091513-02)
Next delivery &
Estimated
recovery: No ETA
at this time
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
(NDC 0409-6636-01)
Next delivery and
estimated
recovery TBD
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
(NDC 0409-6651-06)
Available
releasing product
consistently
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
(NDC 0409-6653-05)
Available
releasing product
consistently
Demand
increase for the
drug
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 mEq/100 mL (NDC
0409-7074-26)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 mEq/50 mL (NDC
0409-7075-14)
Available
Other
88
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/100 mL (NDC
0409-7075-26)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/50 mL (NDC
0409-7077-14)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
40 mEq/100 mL (NDC
0409-7077-26)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
40 mEq/1000 mL
(NDC 0409-7116-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/1000 mL in
0.9% NaCl (NDC 04097115-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/1000 mL in
5% dextrose (NDC
0409-7905-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/1000 mL in
5% Dex/Lact Ringers
(NDC 0409-7111-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 mEq/500 mL in 5%
dex & 0.225%
NaCl(NDC 0409-790103)
Next delivery &
Estimated
recovery: No ETA
at this time
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 mEq/ 500 mL in 5%
dex 0.45% NaCl(NDC
0409-7902-03)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/1000 mL in
5% dex& 0.225%
NaCl(NDC 0409-790109)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/1000 mL in
5% dex& 0.45% NaCl
(NDC 0409-7902-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
30 mEq/1000 mL in
5% dex& 0.45% NaCl
(NDC 0409-7903-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
40 mEq/1000 mL in
5% dex& 0.45% NaCl
(NDC 0409-7904-09)
Available
Other
89
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 mEq/1000 mL in
5% dex & 0.45% NaCl
(NDC 0409-7993-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
20 mEq/1000 mL in
5% dex & 0.9% NaCl
(NDC 0409-7107-09)
Available
Other
Potassium
Chloride Injection
5/15/2012
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
40 mEq/1000 mL in
5% dex & 0.9% NaCl
(NDC 0409-7109-09)
Available
Other
Reserpine Tablets
Reserpine Tablets
Reserpine Tablets
Reserpine Tablets
Sacrosidase
(Sucraid) Oral
Solution
4/17/2013
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
0.25 mg 100s (NDC
0185-0134-01)
currently
unavailable
estimated
recovery TBD.
4/17/2013
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
0.25 mg 1000s (NDC
0185-0134-10)
currently
unavailable
estimated
recovery TBD.
4/17/2013
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
0.1 mg 100s (NDC
0185-0032-01)
currently
unavailable
estimated
recovery TBD.
4/17/2013
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
0.1 mg 1000s (NDC
0185-0032-10)
currently
unavailable
estimated
recovery TBD.
8500 I.U./mL 118 mL
per bottle 2
bottles/pack (NDC
67871-111-04)
Limited supply
available during
estimated
shortage from the
end of July 2015
until the end of
October 2015.
7/9/2015
Currently
in Shortage
QOL Medical LLC
(New 07/09/2015)
API and Raw
Material
changes.
required
changes
currently in
process
API and Raw
Material
changes.
required
changes
currently in
process
API and Raw
Material
changes.
required
changes
currently in
process
API and Raw
Material
changes.
required
changes
currently in
process
Requirements
related to
complying with
good
manufacturing
practices.
90
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Sodium Acetate
Injection USP
2/3/2016
Currently
in Shortage
Fresenius Kabi
USA LLC (New
03/23/2016)
32.8% 400 mEq
100mL PBP (NDC
63323-0032-61)
Available
Demand
increase for the
drug
Available
releasing product
consistently
Demand
increase for the
drug
Available
releasing product
consistently
Demand
increase for the
drug
Available
releasing product
consistently
Demand
increase for the
drug
Amphastar will
regularly release
products.
Demand
increase for the
drug
Available
Other
Next delivery: Mid
May 2016;
Estimated
recovery: 2Q 2016
Other
Next delivery:
Early May 2016;
Estimated
recovery: 2Q 2016
Other
Sodium Acetate
Injection USP
2/3/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Sodium Acetate
Injection USP
2/3/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Sodium Acetate
Injection USP
2/3/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Currently
in Shortage
Amphastar
Pharmaceuticals
Inc./IMS
(Reverified
03/15/2016)
Sodium
Bicarbonate
Injection USP
Sodium
Bicarbonate
Injection USP
Sodium
Bicarbonate
Injection USP
Sodium
Bicarbonate
Injection USP
2/4/2016
2/4/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2/4/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2/4/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
2 mEq/mL; 100
mEq/50 mL Pharmacy
Bulk Package Glass
Fliptop Vial (NDC
0409-3299-05)
2 mEq/mL; 200
mEq/100 mL
Pharmacy Bulk
Vial (NDC 0409-329906)
2 mEq/mL; 40 mEq/20
mL Single Dose Plastic
Fliptop Vial (NDC
0409-7299-73)
Sodium Bicarbonate
Inj. USP 8.4% 50mL
Luer-Jet Prefilled
Syringe (NDC 05483352-00) (new NDC
76329-3352-1)
[Neut™ (Sodium
Bicarbonate Additive
Solution)] 4%
(200mg/5mL) Single
(NDC 0409-6609-02)
(Infant) 4.2% (0.5
mEq/mL); 5 mEq/10
mL LifeShield™
Abboject™ Glass
Syringe with Male
Luer Lock Adapter and
20-Gauge protected
needle (NDC 04095534-34)
7.5% (0.9 mEq/mL);
44.6 mEq/50 mL
LifeShield™
Abboject™ Glass
Syringe with Male
18-Gauge protected
needle (NDC 04094916-34)
91
Name
Sodium
Bicarbonate
Injection USP
Sodium
Bicarbonate
Injection USP
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
2/4/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
8.4% (1 mEq/mL); 50
mEq/50 mL Single
(NDC 0409-6625-02)
Available
releasing product
consistently
Demand
increase for the
drug
Next delivery:
Early April
Estimated
recovery: 2Q 2016
Other
Next delivery:
April Estimated
recovery: 2Q 2016
Other
8.4% (1 mEq/mL); 50
mEq/50 mL
LifeShield™
Abboject™ Glass
Syringe (18 G x 1
1/2)(NDC 0409-663734)
(Pediatric) 8.4% (1
mEq/mL); 10 mEq/10
mL LifeShield™
Abboject™ Glass
Syringe with Male
20-Gauge protected
needle (NDC 04094900-34)
2/4/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Sodium
Bicarbonate
Injection USP
2/4/2016
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
0.9% NaCl 250mL bag
PVC/DEHP-free (NDC
00264-7800-20)
Intermittent
interruptions in
supply
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
0.9% NaCl 500mL bag
PVC/DEHP-free (NDC
00264-7800-10)
Intermittent
interruptions in
supply
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
B. Braun Medical
Inc. (Revised
06/18/2015)
0.9% NaCl 1000mL
bag PVC/DEHP-free
(NDC 00264-7800-00)
Intermittent
interruptions in
supply
Demand
increase for the
drug
B. Braun Medical
Inc. (Revised
06/18/2015)
Sodium Chloride 0.9%
w/v Intravenous
Infusion BP in the
Ecoflac® plus
container sizes: 500
mL (NDC 0264-999910)
Available
Available
Baxter Healthcare
(Reverified
03/25/2016)
w/v Intravenous
Infusion in Viaflo®
Non-PVC Containers
(UK/ English label)
Viaflo® container
sizes: 250 mL (NDC
0338-9542-01)
Product code FE1322
Available for
current
customers.
Other
Sodium Chloride
0.9% Injection
Bags
Sodium Chloride
0.9% Injection
Bags
1/15/2014
1/15/2014
Currently
in Shortage
Currently
in Shortage
92
Date First
Reported
Name
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
w/v Intravenous
Non-PVC Containers
(UK/ English label)
Viaflo® container
sizes: 250 mL 250 mL
(NDC 0338-9542-04)
Product code
FE1322D
Available for
current
customers.
Other
150mL (NDC 003380049-01)
Unavailable.
Production is
planned to
resume in 1Q
2016.
Demand
increase for the
drug
Status
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
250 mL (NDC 003380049-02)
Available
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
250mL PVC/DEHP-free
(NDC 00338-6304-02)
Available for
current
customers.
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
500 mL (NDC 003380049-03)
Available
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
500 mL PVC/DEHPfree (NDC 003386304-03)
Available for
current
customers.
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
1000 mL (NDC 003380049-04)
Available for
current
customers.
Demand
increase for the
drug
93
Date First
Reported
Name
Status
Company
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1/15/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1/15/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
Sodium Chloride
0.9% Injection
Bags
Sodium Chloride
0.9% Injection
Bags
Sodium Chloride
0.9% Injection
Bags
Sodium Chloride
0.9% Injection
Bags
1/15/2014
1/15/2014
Presentation
w/v Intravenous
Non-PVC Containers
(UK/ English label)
Viaflo® container
sizes: 500 mL (NDC
0338-9542-02) 250 mL
Product code FE1323;
500 mL (NDC 03389542-05) Product
code FE1323D
w/v Intravenous
Non-PVC Containers
(UK/ English label)
Viaflo® container
sizes: 1000 mL (NDC
0338-9542-06)
Product Code
FE1324D
0.9% Freeflex
Injection Solution for
Intravenous Infusion
(Australian label /
English) 100 mL (NDC
63323-623-00)
0.9% Freeflex
(Australian label /
English) 500 mL (NDC
63323-623-59)
0.9% Freeflex
(Australian label /
English) 1000 mL
(NDC 63323-623-10)
0.9% Freeflex
(Scandinavian label)
freeflex container: 50
mL (NDC 63323-62357)
Availability
Shortage
Reason
Available for
current
customers.
Other
Available for
current
customers.
Other
No further 100 mL
will be available.
Please check
wholesaler
inventory.
Other
No further 500 mL
will be available.
Please check
wholesaler
inventory.
Other
No further 1000
mL will be
available. Please
check wholesaler
inventory.
Other
No further
Scandinavian
inventory
available.
Other
94
Date First
Reported
Name
Status
Company
Presentation
0.9% Freeflex
freeflex container:
100 mL (NDC 63323623-09)
0.9% Freeflex
freeflex container:
500 mL (NDC 63323623-51)
0.9% Freeflex
(Australian label /
English) 50 mL (NDC
63323-623-50)
Availability
Shortage
Reason
No further
Scandinavian
inventory
available.
Other
No further
Scandinavian
inventory
available.
Other
No further 50 mL
will be available.
Please check
wholesaler
inventory.
Other
1/15/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1/15/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
1/15/2014
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Fresenius Medical
Care North
America (New
03/13/2014)
1000ml (NDC 49230300-10)
Fresenius has this
product on
allocation
Demand
increase for the
drug
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
50 mL flexible
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
100 mL flexible
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
100 mL flexible
container-4 pack (NDC
0409-7984-37)
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
150mL flexible
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
250mL Vis-IV
container PVC/DEHPfree (NDC 0409-798325)
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
250mL flexible
Available
Other
Sodium Chloride
0.9% Injection
Bags
Sodium Chloride
0.9% Injection
Bags
Sodium Chloride
0.9% Injection
Bags
95
Name
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
250mL flexible
container 2 port (NDC
0409-7983-53)
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
250mL ADD-Vantage
flexible container
(NDC 0409-7101-02)
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
500mL flexible
container 2 port (NDC
0409-7983-55)
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
500mL flexible
Available
Other
Sodium Chloride
0.9% Injection
Bags
1/15/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1000mL flexible
Available
Other
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
30 mL vials pkg of 25
(NDC 00517-2930-25)
Unavailable- no
product available
for release. No
plan to
manufacture.
Discontinuation
of the
manufacture of
the drug
Sodium Chloride
23.4% Injection
Currently
in Shortage
American
Regent/Luitpold
(Reverified
03/17/2016)
100 mL vials pkg of 25
(NDC 00517-2900-25)
Unavailable- no
product available
for release. No
plan to
manufacture.
Discontinuation
of the
manufacture of
the drug
Sodium Chloride
23.4% Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
30 mL vials (NDC
63323-0087-30)
Available
Demand
increase for the
drug
Sodium Chloride
23.4% Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
100 mL vials (NDC
63323-0088-61)
Backordered.
Next release date
not available at
this time.
Demand
increase for the
drug
Sodium Chloride
23.4% Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
200 mL vials (NDC
63323-0088-63)
Backordered.
Next release
anticipated March
2016.
Demand
increase for the
drug
Sodium Chloride
23.4% Injection
96
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Sodium Chloride
23.4% Injection
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
4 mEq/mL; 100 mL
bottle (NDC 04091141-02)
Next delivery: 2Q
2016; Estimated
recovery: Early 2Q
2016
Demand
increase for the
drug
Sodium Chloride
23.4% Injection
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
4 mEq/mL; 250 mL
bottle (NDC 04091130-02)
Next delivery &
Estimated
recovery: TBD
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
50 mcg/mL 1 mL
ampoule 10 pack(NDC
17478-0050-01)
Readily Available
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
50 mcg/mL 2 mL
ampoule 10 pack(NDC
17478-0050-02)
Readily Available
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Akorn
Pharmaceuticals
(Reverified
12/12/2014)
50mcg/ml 5ml ampule
10 pack (NDC 174780050-05)
Readily Available
Delay in
shipping of the
drug
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
50 mcg/mL; 1 mL
ampule (NDC 04093380-31)
Next delivery and
estimated
recovery TBD.
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
50 mcg/mL; 1 mL vial
(NDC 0409-3382-21)
Available
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
50 mcg/mL; 2 mL
ampule (NDC 04093380-32)
Next delivery and
estimated
recovery TBD.
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
50 mcg/m;L 2 mL vial
(NDC 0409-3382-22)
Next delivery and
estimated
recovery TBD.
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
50 mcg/mL; 5 mL
ampule (NDC 04093380-35)
Next delivery and
estimated
recovery TBD.
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
50 mcg/mL; 5 mL vial
(NDC 0409-3382-25)
Available
Other
Name
97
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 1 mL
ampul (NDC 06416110-10)
West-Ward has
inventory
available.
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 2 mL
ampul(NDC 06416111-10)
West-Ward has
inventory
available.
Other
Sufentanil Citrate
(Sufenta)
Injection
Currently
in Shortage
West-Ward
Pharmaceuticals
(Revised
03/10/2016)
50 mcg/mL 5 mL
ampul(NDC 06416112-10)
West-Ward has
inventory
available.
Demand
increase for the
drug
11/20/2015
Currently
in Shortage
GlaxoSmithKline
(Revised
03/11/2016)
Limited
availability. Next
resupply in April
2016.
Shortage of an
active
ingredient.
Sumatriptan
(Imitrex) Nasal
Spray
11/20/2015
Currently
in Shortage
GlaxoSmithKline
(Revised
03/11/2016)
Limited
availability. Next
resupply in April
2016.
Shortage of an
active
ingredient.
Sumatriptan
(Imitrex) Nasal
Spray
11/20/2015
Currently
in Shortage
GlaxoSmithKline
(Revised
03/11/2016)
Supply not
available until
April 2016.
Shortage of an
active
ingredient.
Sumatriptan
(Imitrex) Nasal
Spray
11/20/2015
Currently
in Shortage
GlaxoSmithKline
(Revised
03/11/2016)
Supply not
available until
April 2016.
Shortage of an
active
ingredient.
DMSA product is
currently not
available.
Estimated return
to market is
August 2016.
Delay in
shipping of the
drug
Name
Sumatriptan
(Imitrex) Nasal
Spray
Technetium
Tc99m Succimer
Injection (DMSA)
10/15/2014
Currently
in Shortage
GE Healthcare
(Revised
07/15/2015)
Sumatriptan
(Imitrex®) Nasal Spray
20 mg (6 doses per
device)(NDC 01730523-00)
Sumatriptan
(Imitrex®) Nasal Spray
5 mg (6 doses per
device)(NDC 01730524-00)
Sumatriptan Nasal
Spray 20 mg 6 doses
per device)(NDC
0781-6523-86)
Sumatriptan Nasal
Spray 5 mg (6 doses
per device)(NDC
0781-6524-86)
DMSA Kit for the
Preparation of
Technetium Tc99m
Succimer Injection
(NDC 17156-525-01)
98
Date First
Reported
Name
Status
Company
Presentation
Availability
Shortage
Reason
Manufacturing
delay
12/10/2015
Currently
in Shortage
Pfizer
Pharmaceuticals
(Reverified
02/05/2016)
Tygacil® (tigecycline)
for Injection
50mg/10ml vial (NDC
00008-4990-20)
Weekly shipments
of 50% of normal
demand will be
sent to
wholesalers and
drop shipments
are available for
all customers.
Projected
recovery expected
in May 2016
10/31/2013
Currently
in Shortage
Mission
Pharmacal
(Revised
09/04/2014)
100mg tablets(NDC
0178-0900-01)
Product has
started shipping.
Shortage of an
active
ingredient
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
10 mg/ml; 2ml vial
(NDC 63323-0305-02)
Available
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
40 mg/mL 2 mL vial
(NDC 63323-0306-02)
Available
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
40 mg/mL 30 mL vial
(NDC 63323-0306-30)
Available
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
40 mg/mL 50 mL vial
(NDC 63323-0307-51)
Backordered.
Next release
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
40 mg/mL 2 mL
Novaplus vial (NDC
63323-0306-55)
Backordered. No
estimated delivery
at this time.
Demand
increase for the
drug
Tigecycline
(Tygacil) Injection
Tiopronin (Thiola)
99
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
40 mg/mL 30 mL
Novaplus vial (NDC
63323-0306-56)
Backordered. No
estimated delivery
at this time.
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
Available
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Fresenius Kabi
USA LLC
(Reverified
03/23/2016)
Backordered.
Next release
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
80 mg/mL in 0.9%
NaCl; 100 mL (NDC
0409-3470-23)
Discontinued
Discontinuation
of the
manufacturer
of the drug
Tobramycin
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
10 mg/mL; 2 mL vial
(NDC 0409-3577-01)
Next delivery and
estimated
recovery TBD.
Other
Tobramycin
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
40 mg/mL; 2 mL vial
(NDC 0409-3578-01)
Next delivery:
Early April
Estimated
recovery 2Q 2016
Other
Tobramycin
Injection
Currently
in Shortage
Hospira Inc.
(Reverified
03/22/2016)
40 mg/mL; 50 mL vial
(NDC 0409-3590-02)
Discontinued
Discontinuation
of the
manufacturer
of the drug
Tobramycin
Injection
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
40 mg/mL 2 mL vial
(NDC 67457-473-22)
Unavailable.
Estimated
Recovery: TBD
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
40 mg/mL 30 mL vial
(NDC 67457-428-30)
Unavailable.
Estimated
Recovery: TBD
Demand
increase for the
drug
Tobramycin
Injection
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
40 mg/mL 2 mL vial
(NDC 00703-9402-04)
Teva expects to
have product
available Q4'16
Method
remediation
delays
Name
Tobramycin
Injection
Powder for solution
1.2 gram 50 mL vial
preservative-free 6
count (NDC 633230303-51)
Powder for solution
1.2 gram 50 mL
Novaplus vial
preservative-free 6
count (NDC 633230303-55)
100
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
40 mg/mL 30 mL vial
(NDC 00703-9416-01)
Teva expects to
have product
available Q4'16
Method
remediation
delays
Currently
in Shortage
X-GEN
Pharmaceuticals
INC (New
01/22/2015)
Powder for solution
1.2gm/pharmacy bulk
pack 6 pack carton
(NDC 39822-0412-6)
Both sizes are in
stock and being
distributed. No
shortages are
expected
Other
Tobramycin
Injection
Currently
in Shortage
X-GEN
Pharmaceuticals
INC (New
01/22/2015)
Powder for solution
1.2gm/pharmacy bulk
pack Single vial carton
(NDC 39822-0412-1)
Both sizes are in
stock and being
distributed. No
shortages are
expected
Other
Tretinoin
Capsules
2/19/2016
Currently
in Shortage
Cheplapharm
Arzneimittel
GmbH (Revised
03/28/2016)
VESANOID® 10 mg
Capsules (NDC 101532341-1)
Available
Other
2/19/2016
Currently
in Shortage
Par
Pharmaceutical
(Revised
03/10/2016)
Tretinoin 10 mg
Available
Delay in
shipping of the
drug
2/19/2016
Currently
in Shortage
Teva
Pharmaceuticals
(Revised
03/11/2016)
Tretinoin 10 mg
Available
Shortage of
active
ingredient
20 mg/mL (fill in a 2
mL vial) (NDC 07813085-71)
Currently
unavailable
estimated
recovery H1 2016.
Requirements
related to
complying with
good
manufacturing
practices.
20 mg/mL (fill in a 10
mL vial) (NDC 07813085-75)
Currently
unavailable
estimated
recovery H1 2016.
Requirements
related to
complying with
good
manufacturing
practices.
Name
Tobramycin
Injection
Tobramycin
Injection
Tretinoin
Capsules
Tretinoin
Capsules
Triamcinolone
Hexacetonide
Injectable
Suspension
(Aristospan)
Triamcinolone
Hexacetonide
Injectable
Suspension
(Aristospan)
10/3/2014
10/3/2014
Currently
in Shortage
Currently
in Shortage
Sandoz
(Reverified
03/14/2016)
Sandoz
(Reverified
03/14/2016)
101
Name
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
25 mg 30s (NDC
45963-293-30)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
25 mg 90s (NDC
45963-293-08)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
25 mg 270s (NDC
45963-293-27)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
50 mg 30s (NDC
45963-294-30)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
50 mg 90s (NDC
45963-294-08)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
50 mg 270s (NDC
45963-294-27)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Mikah Pharma LLC
c/o Epic Pharma
LLC (Reverified
01/22/2015)
100 mg 30s (NDC
45963-295-30)
Product currently
unavailable
Shortage of
active
ingredient
8/18/2014
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
SURMONTIL(R)
CAPSULES 50MG 100
(NDC 51285-0539-02)
Product is
currently
available.
Other
102
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
8/18/2014
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
SURMONTIL(R)
CAPSULES 25MG 100
(NDC 51285-0538-02)
Product is
currently
available.
Other
8/18/2014
Currently
in Shortage
Teva
Pharmaceuticals
(Reverified
01/13/2016)
SURMONTIL(R)
CAPSULES 100MG 100
(NDC 51285-0554-02 )
Product is
currently
available.
Other
11/7/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
500mg/100 mL
GALAXY Plastic
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
750 mg/150 mL
(underfill in 200 mL)
GALAXY Plastic
Available
Demand
increase for the
drug
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Baxter Healthcare
(Reverified
03/25/2016)
1 gram/200 mL
GALAXY Plastic
Available
Demand
increase for the
drug
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
500 mg / single dose
vial (NDC 63323-22110)
Available
Demand
increase for the
drug
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
1 g / single dose vial
(NDC 63323-284-20)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
5 g / PBP (NDC 63323295-61)
Backordered.
Next release
anticipated April
2016.
Demand
increase for the
drug
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Fresenius Kabi
USA LLC (Revised
03/23/2016)
10 g / PBP (NDC
63323-314-61)
Backordered.
Next release
anticipated March
2016.
Demand
increase for the
drug
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
500 mg Single Dose
Glass Fliptop Vial
(NDC 0409-4332-01)
Available
Other
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
750 mg Single Dose
Glass Fliptop Vial
(NDC 0409-6531-02)
Available
Other
Name
Trimipramine
Maleate
(SURMONTIL)
Capsules
Trimipramine
Maleate
(SURMONTIL)
Capsules
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
103
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
500 mg Single Dose
ADD-Vantage™ Glass
Vial (NDC 0409-653401)
Available
Other
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
750 mg Single Dose
ADD-Vantage; Glass
Vial (NDC 0409-653101)
Next delivery:
Early March 2016;
Estimated
recovery 2Q 2016
Demand
increase for the
drug
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1 g Single Dose Glass
Fliptop Vial (NDC
0409-6533-01)
Available
Other
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
1 g Single Dose ADDVantage™ Glass Vial
(NDC 0409-6535-01)
Available
Other
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
5 g Pharmacy Bulk
Vial (NDC 0409-650901)
Available
Other
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
Currently
in Shortage
Hospira Inc.
(Revised
03/22/2016)
10 g Pharmacy Bulk
Package Glass Bottle
(NDC 0409-6510-01)
Available
Other
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
500mg Pkg of 10 (NDC
67457-339-50)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
1g Pkg of 10 (NDC
67457-340-01)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
10g Pkg of 1 (NDC
67457-342-10)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
5g Pkg of 1 (NDC
67457-341-05)
Available
Demand
increase for the
drug
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
5g Pkg of 1 Novaplus
(NDC 67457-613-10)
Available
Demand
increase for the
drug
Name
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
11/7/2014
104
Name
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Vancomycin
Hydrochloride for
Injection USP
Date First
Reported
Status
Company
Presentation
Availability
Shortage
Reason
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
500mg Pkg of 10
Novaplus (NDC 67457611-10)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
1g Pkg of 10 Novaplus
(NDC 67457-612-20)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Mylan
Institutional
(Reverified
03/24/2016)
10 g Pkg of 1
NOVAPLUS (NDC
67457-614-10)
Available
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
10g vial Pharmacy
Bulk Package (NDC
25021-158-99)
Allocation
Demand
increase for the
drug
11/7/2014
Currently
in Shortage
Sagent
Pharmaceuticals
(Reverified
03/22/2016)
5g vial Pharmacy Bulk
Available
Demand
increase for the
drug
*Please refer to ASHP website for more information
105
NEW DRUGS COMING TO MARKET
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
Selective
serotonin inverse
agonist
NuplazidTM
(pimavanserin)
Acadia
Oral
Psychosis
associated with
parkinson’s disease
Obeticholic acid
Intercept
Oral
Rociletinib
(CO-1686)
Zinbryta
(daclizumab HYP)
Sarilumab
Clovis
Oncology
Biogen
Oral
Primary billary
cirrhosis
Mutant EGFR
T790M NSCLC
Multiple sclerosis
Subcutanous
Translarna™
(Ataluren)
Regeneron/
Sanofi
PTC
Therapeutics
Brodalumab
Valeant
Suncutanous
Andexanet
Pfizer
IV
Baricitinib
Eli-Lilly
Oral
Subcutanous
Oral
Daclatasvir/Asuna Bristol Myers Oral
previr/Beclabuvir Squibb
Buparlisib
Novartis
Oral
Ztilido (lidocaine
patch 1.8%)
Lupuzor™
(rigerimod)
Elagolix
Scilex
Topical patch
ImmunPharm
a PLC
Abbvie
Subcutanous
Oral
Farnesoid-X
receptor agoinst
Irreverable
inhibitor of EGFR
Interleukin-2R
receptor inhibitor
RA
Targets
interleukin-6r
Nonsence mutation Gene
Duchenne
transcription
Muscular
modulate,
Dystrophy and
protein
Cystic Fibrosis
restoration
Psorasis
Interleukin-17
inhibitor
Anticoagulant
Factor Xa
reversal
antidote
RA
Janus Kinase-1
and 2 inhibitor
HCV genotype 1
NS5B polymerase
inhibitor/ NS5A
inhibitor/
protease inhibitor
nd
2 line for
Pan-class 1 P13K
metastatic, ER+
inhibitor
breast cancer
resistant to
aromitase
inhibitors
Post-herpetic
Local anesthetic
neuralgia
Systemic lupus
P140 peptide
erythematosus
Uterine fibroids
GnRH antagonist
and endometiosis
MARKET
RELEASE
5/1/2016
5/29/2016
6/28/2016
Q2 2016
10/30/2016
Q4 2016
Q4 2016
Q4 2016
2016
2016
2016
2016
2016
2016
106
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
MARKET
RELEASE
Midostaurin
(PKC412)
Amigal
(Migalstat)
Baxdela
(delafloxacin)
Novartis
Oral
AML
Kinase inhibitor
2016
Amicus
Oral
Fabry disease
Binds alpha-Gal A
2016
Melinta
Oral and IV
Fluoroquinolone
2016
Glycopyrronium/f
ormoterol (PT003)
Eravacycline
AstraZeneca
Inhaler
Gonorrhea and
bacterial skin/soft
tissue infections
Asthma/COPD
Anticholinergic
combination
2016
Tetraphase
Oral and IV
Complicated UTIs
2016
MK-8342B
Hydrocodone ER
(CEP-33237)
Oxycodone/naltre
xone ER (ALO-02)
Ribociclib
Merck
Teva
Vaginal ring
Oral
Contraception
Pain
Pfizer
Oral
Pain
Novartis
Oral
Pacritinib
CTI BioPharma
Oral
HR+, HER2-,
postmenopausal
advanced breast
cancer
Myelofibrosis
Noval synthetic
tetracycline
Contraceptive
Opioid receptor
agonist
Opioid receptor
agonist
CDK4/6 inhibitor
2016
Surotomycin
Cubist
Oral
Janus Kinase-2/
FMS-like tyrosine
kinase-3 inhibitor
Antibacteral
lipopeptide
C. diff associated
diarrhea
2016
2016
2016
2016
2016
107

April 2016 - PerformRx

Transcription

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