June 2012 Drug Information Update - Pharmacy Benefits ...

June 2012 

Drug Information Update

Drug Information Update 

Table of Contents 

First-Time Generics 

New Drug Entities 

New Indications 

FDA News/Bulletins/Advisories/Safety Alerts 

Studies 

Recalls 

Current Drug Shortages 

Page 3 

Page 3-5 

Page 6-7 

Page 7-9 

Page 9-24 

Page 24-32 

Page 32-110 

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First-Time Generics 

GENERIC DRUG NAME 

GENERIC 

MANUFACTURER 

BRAND NAME 

APPROVAL 

DATE 

Carbidopa/Levodopa/Entacapone Wockhardt USA L Stalevo Tablet 04/09/12 

Enoxaparin Sodium 

Sandoz 

Lovenox 300mg/3mL 

Vial 

04/26/12 

Prenatal Vit #86/Iron Bisgly/F WH Nutritionals Nestabs Prenatal Tablet 05/08/12 

PNV #87/Iron Bisgly/FA/DHA 

Hydromorphone HCl 

Tranexamic Acid 

WH Nutritionals 

Roxane Labs 

APP Pharmaceuticals 

Nestabs DHA Combo 

Pack 

Dilaudid-5 1mg/mL 

Liquid 

Cyklokapron 100mg/mL 

Ampule 

05/08/12 

05/08/12 

05/09/12 

Genistein/Cit Zn Bisgly/Vit D Virtus Pharmaceuticals Fosteum Capsule 05/11/12 

Emollient Combination No. 53 Prugen Pharmaceuticals Hylatopic Plus Cream 05/17/12 

Clopidogrel Bisulfate Teva USA Plavix Tablet 05/18/12 

Clopidogrel Bisulfate Mylan Plavix Tablet 05/17/12 

Gruenhaupt, Mark R.Ph. Argus Health Systems, Inc. c2005 Available from: www.argushealth.com [cited May 10, 2012]. 


New Drug Entities 

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES 

PHOSPHATE 

REPLACEMENT 

LOCAL ANESTHETICS 

POTASSIUM 

PHOSPHATENS IV 

PIGGYBACK 

BUFFERED 

LIDOCAINENS DISP 

SYRIN 

POTASSIUM PHOS IN 

0.9 % NACL 

LIDOCAIN/ 8.4% 

NAHCO3/ 

0.9% NACL 

10MMOL/ 100 

New Strength and 

Dosage Form 

1% (0.25ML) New Strength 

GENERAL ANESTHETICS, 

INJECTABLE 

KETAMINE HCL DISP 

SYRIN 

KETAMINE HCL 20 MG/ 2 ML New Strength 

ANALGESICS, NARCOTICS 

FENTANYL CITRATE- 

NS IV PLAST BAG 

FENTANYL CITRATE- 

0.9% NACL/PF 

4MCG/ ML 

New Strength 


HYDROMORPHONE 

HCL-NS PCA VIAL 

HYDROMORPHONE 

HCL/0.9% NACL/PF 

6MG/ 30ML 

New Strength and 

Dosage Form 


MEPERIDINE HCL- 

0.9% NACL PCA 

SYRIN 

MEPERIDINE HCL IN 

0.9 % NACL 

550MG/ 55ML 

New Strength 

ANALGESICS NARCOTIC, 

ANESTHETIC ADJUNCT 

AGENTS 

SUFENTANIL 

CITRATE DISP SYRIN 

SUFENTANIL 

CITRATE/PF 

100MCG/ 2ML 

New Dosage Form 

3

SSRI & 5-HT1A PARTIAL 

AGONIST ANTI- 

DEPRESSANT 

VIIBRYD TAB DS PK 

VILAZODONE 

HYDROCHLORIDE 

10-20-40MG 

New Strength 

and Dosage Form 

BELLADONNA 

ALKALOIDS 

ATROPINE SULFATE 

DISP SYRIN 

ATROPINE SULFATE 

0.4 MG/ ML 

New Route and 

Dosage Form 

ROSACEA AGENTS, 

TOPICAL 

ROSADAN KIT 

CL&GEL 

METRONIDAZOLE/ 

SKIN CLEANSR #23 

0.75 % New Dosage Form 

HEPARIN AND RELATED 

PREPARATIONS 

HEPARIN SODIUM-NS 

IV SOLN 

HEPARIN SOD, 

PORCINE- 0.9% NACL 

5K/ 1000 ML New Strength 

ANTIDIU-RETIC AND 

VASOPRESSOR 

HORMONES 

ANTIDIURETIC AND 

VASOPRESSOR 

HORMONES 

URINARY TRACT 

ANTISPASMODIC/ 

ANTIINCONTINENCE 

AGENT 

PRENATAL VITAMIN 

PREPARATIONS 

VASOPRESSIN- D5W 

IV PLAST.BAG 

VASOPRESSIN- NS 

IV PLAST.BAG 

GELNIQUE GEL MD 

PM 

BAL-CARE DHA 

ESSENTIAL 

CMBPKGDRCP 

VASOPRESS IN D5W 0.6 UNIT/ 1 

VASO-PRESSIN IN 0.9% 

NACL 

0.6 UNIT/ 1 

New Strength 

Route and Dosage 

Form 

New Strength 

Route and Dosage 

Form 

OXYBUTYNIN 28MG/ 0.92G New Strength 

PNV100/IRON 

EDTA&PS/ FA/ 

OMEGA3 

27-1-374MG 

New Combination 

PRENATAL VITAMIN 

PREPARATIONS 

PRENATE MINI 

CAPSULE 

PRENATAL VIT 

NO.44/IRON/FA/DHA 

29-1-350MG 



METHADONE HCL 

ORAL DISP SYRIN 

METHADONE HCL 10 MG/ ML New Dosage Form 

ANTISEBORRHEIC 

AGENTS 

PROMISEB 

COMPLETE KIT 

CL&CRM 

EMOLLIENT #43/ SKIN 

CLEANSER #27 


RADIOACTIVE 

THERAPEUTIC AGENTS 

SODIUM IODIDE I-123 

CAPSULE 

SODIUM IODIDE-123 7.4 MBQ New Strength 

CHEMO-THERAPY 

RESCUE/ ANTIDOTE 

AGENTS 

ANTI-VIRAL HIVSPECIFIC, 

NONNUCLEOSIDE, RTI 

VORAXAZE VIAL GLUCARPIDASE 1000 UNIT New Entity 

INTELENCE TABLET ETRAVIRINE 25 MG New Strength 

BICARBONATE 

PRODUCING/ 

CONTAINING AGENTS 

SODIUM BICARB IN 

STERILE WATER DISP 

SYRIN 

SODIUM BICARB IN 

STERILE WATER 

5 MEQ/10ML New Strength 

ANTI- ULCER-H. PYLORI 

AGENTS 

OMECLAMOXPAK 

COMBO PK 

OMEPRAZOLE/ 

CLARITH/ 

AMOXICILLIN 

20(20)-500 New Combination 

4

ANTI-DIARRHEALS 

OPIUM TINCTURE 

DISP SYRIN 

OPIUM TINCTURE 10 MG/ ML New Dosage Form 

DIGITALIS GLYCOSIDES DIGOXIN SOLUTION DIGOXIN 0.25MG/ 5ML New Strength 

CALCIUM REPLACEMENT 

CALCIUM CHLORIDE- 

NS IV PIGGYBACK 

CALCIUM CHLORIDE 

IN 0.9% NACL 

1 G/ 100 ML New Strength 

CALCIUM REPLACEMENT 

CALCIUM CHLORIDE- 

NS IV PIGGYBACK 

CALCIUM CHLORIDE 

IN 0.9% NACL 

2 G/ 100 ML New Strength 


HYDRO MORPHONE 

HCL-NS PCA SYRING 

HYDROMORPHONE 

HCL/0.9% NACL/PF 

6MG/ 30ML 

New Strength 

ANALGESICS NARCOTIC, 

ANESTHETIC ADJUNCT 

AGENTS 

FENTANYL CITRATE 

DISP SYRING 

FENTANYL 

CITRATE/PF 

500 MCG/10 New Strength 

KERATOLYTICS 

URAMAXIN GT KT 

CRM GEL 

UREA/ EMOLLIENT 

COMBINATION #65 

45 % New Combination 


VASOPRESSOR 

HORMONES 


VASOPRESSOR 

HORMONES 


VASOPRESSOR 

HORMONES 


VASOPRESSOR 

HORMONES 


VASOPRESSOR 

HORMONES 


VASOPRESSOR 

HORMONES 

VASOPRESSIND5W IV 

PLAST. BAG 


PLAST. BAG 


PLAST. BAG 

VASOPRESSINNS IV 

PLAST. BAG 


PLAST. BAG 


PLAST. BAG 

VASO-PRESSIN IN 

D5W 


D5W 


D5W 


NACL 


NACL 


NACL 

50/250 ML New Strength 






HEPATITIS C TREATMENT 

AGENTS 

HEPATITIS C TREATMENT 

AGENTS 

RIBAPAK TAB DS PK RIBAVIRIN 200-400MG New Strength 

RIBAPAK TAB DS PK RIBAVIRIN 200-400 (7) New Strength 

METABOLIC DISEASE 

ENZYME REPLACEMENT, 

GAUCHER'S 

ELELYSO IV VIAL 

TALIGLUCERASE 

ALFA 

200 UNIT New Entity 



5

New Indications (Existing Drugs) 

Afinitor® 

April 26, 2012 

Novartis drug Afinitor® approved by FDA as first medication to treat patients with non-cancerous kidney 

tumors associated with TSC. 

Kidney tumors affect up to 80% of patients with tuberous sclerosis complex (TSC) and growing tumors 

may lead to unpredictable life-threatening complications. Prior to the approval of Afinitor, surgical 

intervention was the only treatment option for patients with these kidney tumors associated with TSC. 

Approval marks the second TSC-related indication for Afinitor in the US, where it is also approved to 

treat subependymal giant cell astrocytoma (SEGA) in TSC. Novartis announced today that the US Food 

and Drug Administration (FDA) approved Afinitor® (everolimus) tablets for the treatment of adult 

patients with kidney tumors known as renal angiomyolipomas and tuberous sclerosis complex (TSC), 

who do not require immediate surgery. This marks the first approval of a medical treatment in this patient 

population. 

Article link: http://www.novartis.com/newsroom/media-releases/en/2012/1606656.shtml 

Source website: http://www.novartis.com/index.shtml 

Votrient® 


FDA approves Votrient® for treatment of patients with certain types of advanced soft tissue sarcoma. 

GlaxoSmithKline announced today that the U.S. 

Food and Drug Administration (FDA) has approved Votrient® (pazopanib) for the treatment of patients 

with advanced soft tissue sarcoma who have received prior chemotherapy. The U.S. label contains the 

following limitations: The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or 

gastrointestinal stromal tumors has not been demonstrated. 

Article link: http://www.gsk.com/media/pressreleases/2012/2012-pressrelease-1064988.htm 

Source website: http://www.gsk.com/index.htm 

Levaquin® 


FDA approves antibiotic to treat, prevent plague 

U.S. regulators have approved use of a powerful Johnson & Johnson antibiotic to treat plague, an 

extremely rare, sometimes-deadly bacterial infection. The Food and Drug Administration also approved 

Levaquin, known generically as levofloxacin, to reduce risk of people getting plague after exposure to the 

bacteria that cause it. Called Yersinia pestis, the bacteria are considered a potential bioterrorism agent. 

Article link: http://www.usatoday.com/news/health/story/2012-04-28/plague-antibioticdrugfda/54609412/1 

Source website: http://www.usatoday.com/ 

ISENTRESS® 

May 21, 2012 

FDA Approves New Labeling for ISENTRESS® (raltegravir) to Include 156-Week Data Demonstrating 

Long-Term Efficacy, Safety and Tolerability with ISENTRESS in Combination Therapy in Previously 

Untreated Adult Patients Infected with HIV-1. 

Merck today announced the U.S. Food and Drug Administration (FDA) approved a labeling update for 

ISENTRESS® (raltegravir) Film-coated Tablets to include 156-week data from the STARTMRK study 

with ISENTRESS in combination therapy compared to efavirenz in combination therapy in previously 

untreated (treatment-naïve) adult HIV-1-infected patients. The analyses showed that the regimen 

containing ISENTRESS demonstrated long-term viral suppression, a greater immunologic response and a 

proven safety and tolerability profile at 156 weeks. ISENTRESS is the first and only integrase inhibitor 

6

indicated for the treatment of HIV-1 in adult treatment-experienced and treatment-naïve patients as part of 

a combination treatment regimen. 

Article link: http://www.merck.com/newsroom/news-release-archive/prescriptionmedicinenews/2012_0521.html 

Source website: http://www.merck.com/index.html 

Levemir® 


FDA Approves Levemir for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes 

Levemir® Is Now the First and Only Basal Insulin Analog Approved for Use in Patients as Young as 

two. 

Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug 

Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for use in 

children ages two to five years with type 1 diabetes. With the expansion of its pediatric indication, 

Levemir® is now available for type 1 diabetes patients from age two through adulthood and adult patients 

with type 2 diabetes. 

Article link: http://www.pharmalive.com/News/index.cfm?articleid=841002 

Source website: http://www.pharmalive.com/ 

FDA News/Bulletins/Advisories/Safety Alerts 

Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies 

[Updated 05/07/2012] 

FDA notified the public of an increased risk of second primary malignancies (new types of cancer) in 

patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials 

conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had 

an increased risk of developing second primary malignancies compared to similar patients who received a 

placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous 

leukemia, myelodysplastic syndromes, and Hodgkin lymphoma. 

This safety information has been added to the Warnings and Precautions section of the Revlimid drug 

label. The patient Medication Guide is also being updated to inform patients about this risk. Healthcare 

professionals should consider both the potential benefit of Revlimid and the risk of second primary 

malignancies when deciding to treat patients with this drug, and monitor patients for this risk. 

Article 

link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/u 

cm250606.htm 

Source website: http://www.fda.gov/default.htm 

Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death 

After the First Dose 


FDA has completed its evaluation of a report of a patient who died after the first dose of multiple 

sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and 

postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown 

causes. FDA could not definitively conclude that Gilenya was related to any of the deaths. However, 

based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya 

after the first dose. 

Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 

hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some 

patients. For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with 

certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain 

7

antiarrhythmic medications. In addition, FDA is now also recommending that the time of cardiovascular 

monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate 

bradycardia. Extended monitoring should include continuous ECG monitoring that continues overnight. 

Healthcare professionals are encouraged to review the updated drug label for Gilenya, and note specific 

FDA recommendations for monitoring patients and the new contraindications for use in certain patients. 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm28 

4355.htm 


The MedWatch April 2012 Safety Labeling Changes posting includes 43 products with safety 

labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, 

WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. 


The "Summary Page" provides a listing of drug names and safety labeling sections 

revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm 

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and 

WARNINGS sections: 

Aceon (Perindopril Erbumine) 

Altace (Ramipril) 

Atacand (Candesartan Cilexetil) 

Sporanox (Itraconazole) 

Zortress (Everolimus) 

Advicor (Niacin Extended-release/Lovastatin) 

Altoprev (Lovastatin Extended-release) 

Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide) 

Premarin (Conjugated Estrogens,USP) 

Tekamlo (Aliskiren and Amlodipine) 

Tekturna (Aliskiren) 

Tekturna HCT (Aliskiren and Hydrochlorothiazide) 

Vagifem (Estradiol) 

Valturna (Aliskiren and Valsartan) 

Viracept (nelfinavir mesylate) 

Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium) 

Cimzia (Certolizumab Pegol) 

Krystexxa (Pegloticase) 

Levaquin (Levofloxacin) 

Levemir (Insulin Detemir [rDNA origin]) 

Neupro (Rotigotine) 

Nutropin (Somatropin [rDNA origin]) 

Prandimet (Repaglinide and Metformin HCL) 

Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium) 

Sutent (Sunitinib Malate) 

Synagis (palivizumab) 

Tarceva (Erlotinib) 

Victoza (liraglutide [rDNA]) 

Votrient (Pazopanib) 

Xgeva (Denosumab) 

Yasmin (Drospirenone and Ethinyl Estradiol) 

Yaz (Drospirinenone and Ethinyl Estradiol) 

Zegerid (Omeprazole and Sodium Bicarbonate) 

Article 

link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm?source=govdelivery 

8


FDA Statement regarding azithromycin (Zithromax) and the risk of cardiovascular death 

[Posted 05/17/2012] 

The U.S. Food and Drug Administration (FDA) is aware of the study published in the New England 

Journal of Medicine, on May 17, 20121, that compared the risks of cardiovascular death in patients 

treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), levofloxacin (Levaquin), and 

no antibacterial drug. The study reported a small increase in cardiovascular deaths, and in the risk of 

death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to 

persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated 

with levofloxacin treatment were similar to those associated with azithromycin treatment. FDA is 

reviewing the results from this study and will communicate any new information that results from the 

FDA review. Patients taking azithromycin should not stop taking their medicine without talking to their 

healthcare professional. Healthcare professionals should be aware of the potential for QT interval 

prolongation and heart arrhythmias when prescribing or administering antibacterial drugs. (See additional 

information below.) Azithromycin belongs to a class of antibacterial drugs called macrolides, which have 

been associated with cardiovascular effects; specifically, prolongation of the QT interval. Prolongation of 

the QT interval can lead to torsades de pointes (TdP), an abnormal heart rhythm, which can be fatal. 

Azithromycin was the only macrolide examined in the published study; the study did not address other 

macrolide antibacterial drugs, such as clarithromycin (Biaxin) and erythromycin, regarding the potential 

for cardiovascular death. 

In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. 

The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release 

for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval 

prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain 

information about QT interval prolongation in the WARNINGS section. FDA is in the process of 

updating risk information in the drug labels for additional macrolide antibacterial drugs. 

FDA-approved indications for azithromycin include: 

Acute bacterial exacerbations of chronic pulmonary disease 

Acute bacterial sinusitis 

Community-acquired pneumonia 

Pharyngitis/tonsillitis 

Uncomplicated skin and skin structure infections 

Urethritis and cervicitis 

Genital ulcer disease 

FDA will communicate any new information on azithromycin and this study or the potential risk of QT 

interval prolongation after the agency has completed its review. 

Article link: http://www.fda.gov/Drugs/DrugSafety/ucm304372.htm 


Studies 

Strokes Follow Xarelto to Warfarin Switch 


Atrial fibrillation patients who transition from rivaroxaban (Xarelto) to a vitamin K antagonist 

may have an increased risk of stroke, a subanalysis of the ROCKET-AF trial found. At the 

completion of the trial, the risk of stroke for those moving off rivaroxaban was 6.42 per 100 

patient-years compared with 1.73 per 100 patient-years for those on warfarin, Jonathan P. 

Piccini, MD, from Duke University Medical Center, and colleagues reported during an American 

9

Heart Associations's Emerging Science Series webinar. 

Article link: http://www.medpagetoday.com/Cardiology/Strokes/32373 

Source website: http://www.medpagetoday.com/ 

FDA extends review for Salix diarrhea drug 


Salix Pharmaceuticals Ltd said U.S. health regulators have extended the review date by three 

months for its experimental pill for HIV therapy-related diarrhea. The U.S. Food and Drug 

Administration was to review the drug, crofelemer, on June 5. The FDA has notified Salix that it 

requires additional time for a full review but did not seek any additional studies, the company 

said in a statement. 

Article link: http://www.reuters.com/article/2012/04/30/ussalixpharmaceuticalsidUSBRE83T13520120430 

Source website: http://www.reuters.com/ 

Obesity-Linked Diabetes Tougher to Treat in Children 


Type 2 diabetes is harder to treat in children ages 10 to 17 than it is in adults, according to one of 

the first large studies of the disease in younger people. The research also found that diabetes 

develops more rapidly in this age group. About 700 overweight and obese U.S. children and 

teens were given three therapies in the study: The oral drug metformin alone; that medicine 

combined with GlaxoSmithKline Plc (GSK)’s Avandia; and metformin used alone with diet and 

exercise. 

Article link: http://www.bloomberg.com/news/2012-04-30/obesity-linked-diabetes-tougher-totreatin-chindren.html 

Source website: http://www.bloomberg.com/ 

U.S. needs better way to track drug safety – study 


The U.S. Food and Drug Administration should review drugs on a regular basis for as long as 

they are on the market in order to catch any new safety issues, according to a report from an 

independent research body. The Institute of Medicine, which often advises the government on 

scientific matters, said the FDA should then create a comprehensive, publicly available 

document that reflects risks that crop up throughout the "lifecycle" of the drug. 

Article link: http://www.reuters.com/article/2012/05/01/us-fda-iom-safetyidUSBRE84015420120501 


Protalix Wins FDA Approval for Its First Drug on the Market 


The Food and Drug Administration cleared the product called Elelyso to treat a condition caused 

by lack of an enzyme that can lead to spleen and liver enlargement known as Gaucher disease. 

The drug, chemically known as taliglucerase, is approved for Type 1 Gaucher disease affecting 

about 6,000 people in the U.S., the agency said in a statement today. 

Article link: http://www.bloomberg.com/news/2012-05-01/protalix-wins-fda-approval-for-itsfirstdrug-on-the-market.htmll 


10

Testosterone Chases Viagra in Libido Race as Doctors Fret 


Eli Lilly & Co. and Abbott Laboratories are offering help to the 13.8 million American men who 

have low levels of testosterone. Doctors warn that demand for the treatments could lead to 

overuse with deadly side effects. In what may become one of the most sought-after sex 

enhancement treatments since the introduction of Viagra 14 years ago, new testosterone drugs 

from Abbott, Lilly and other drugmakers are in hot demand. Prescriptions for testosterone 

replacement therapies have more than doubled since 2006 to 5.6 million, according to data 

compiled by Bloomberg. 

Article link: http://www.businessweek.com/news/2012-05-02/testosterone-chases-viagra-inlibidorace-as-doctors-fret 

Source website: http://www.businessweek.com/ 

Scientists Spot How Cox-2 Painkillers Raise Heart Risks 


The drugs suppress an enzyme that relaxes blood vessels and guards against clotting, research 

finds. New research has uncovered how some cox-2 painkillers increase the risk for both heart 

attacks and stroke. The once popular cox-2 drugs, Vioxx and Bextra, were pulled off the market 

in 2004 and 2005, respectively, after research showed that both raised the chances of 

cardiovascular trouble. Meanwhile, Celebrex, a painkiller in the same drug class that remains on 

the market, carries a "black box" warning alerting patients to potential heart risks. 

Article link: http://consumer.healthday.com/Article.asp?AID=664338 

Source website: http://consumer.healthday.com/ 

Novartis Drug for Smoker’s Cough Boosts Lung Function in Study 


Novartis’ experimental drug for smoker’s cough helped patients in a late-stage trial, and was at 

least as good as a treatment sold by Boehringer Ingelheim and Pfizer Inc. In a trial among 1,066 

people, those receiving a daily dose of Novartis’s drug, known as NVA237, over 12 weeks were 

able to expel significantly more air from their lungs in one second than those who got a placebo, 

and more than those taking Boehringer and Pfizer’s Spiriva. The results were published in a 

summary of data scheduled to be presented at a conference this month. 

Article link: http://www.businessweek.com/printer/articles/59772?type=bloomberg 


Aspirin as Effective as Warfarin for Heart Failure: Study 


Doctors, patients may opt for cheaper, over-the-counter aspirin, researchers say Aspirin is just as 

effective as the blood-thinner warfarin in preventing stroke and death in heart failure patients 

with a normal heart rhythm, a landmark study indicates. Although the two treatments are equally 

effective, researchers from Columbia University in New York City said their findings could 

prompt more doctors and patients to choose aspirin because it is much cheaper. 

Article link: http://www.nlm.nih.gov/medlineplus/news/fullstory_124760.html 

Source website: http://www.nlm.nih.gov/medlineplus/ 

11

Bayer's Xarelto submitted to FDA for wider approval 


Bayer's oral blood thinner Xarelto has been submitted in the US for additional marketing 

authorization, asking approval for an indication that could add substantial ballast to the drug's 

sales. The group said its development partner Janssen Research and Development has handed in 

a supplemental New Drug Application to the US Food and Drug Administration seeking the all 

clear to market the drug for the treatment of patients with deep vein thrombosis (DVT) or 

pulmonary embolism (PE) and the prevention of recurrent venous thromboembolism (VTE). 

Article link: http://www.pharmatimes.com/Article/12-05- 

03/Bayer_s_Xarelto_submitted_to_FDA_for_wider_approval.aspx 

Source website: http://www.pharmatimes.com/ 

Roche moves forward with injectable Actemra 


Roche's bid to convert its leading biologic drugs to easy-to-use, subcutaneous injections just got 

another boost. The company's Genentech unit announced that Actemra, the rheumatoid arthritis 

treatment, delivered "clinically meaningful and comparable results" when administered under the 

skin. 

Article link: http://www.fiercepharma.com/story/roche-moves-forward-injectable-actemra/2012- 

05-03 

Source website: http://www.fiercepharma.com/ 

U.S. panel likely to back arthritis drug of Abbott rival 


Pfizer Inc.’s experimental rheumatoid arthritis drug goes before an advisory panel next week, a 

potential blockbuster medicine that would revive faith in the company’s research if its benefits 

are deemed to outweigh its side effects. Most industry analysts expect the Food and Drug 

Administration’s expert committee to recommend approval despite risks posed by higher-thannormal 

cholesterol and liver enzyme levels and infections for patients taking tofacitinib during 

clinical trials. 

Article link: http://www.chicagobusiness.com/article/20120503/NEWS03/120509892/u-s-panellikelyto-back-arthritis-drug-of-abbott-rival 

Source website: http://www.chicagobusiness.com/ 

Pfizer's Lyrica falls short in two pain studies 


Pfizer Inc's big-selling Lyrica drug failed to help HIV patients and diabetics relieve forms of 

nerve pain, according to separate clinical trial results released by the drugmaker on Friday. 

Pfizer said it stopped a late-stage study involving patients with HIV neuropathy, a form of nerve 

damage characterized by burning pain. An interim look at the data by independent advisers 

overseeing the study prompted Pfizer to halt the study. 

Article link: http://www.reuters.com/article/2012/05/04/us-pfizer-lyricaidUSBRE8430RH20120504 


12

Analytical Trend Troubles Scientists 


In 2010, two research teams separately analyzed data from the same U.K. patient database to see 

if widely prescribed osteoporosis drugs increased the risk of esophageal cancer. They came to 

surprisingly different conclusions. One study, published in the Journal of the American Medical 

Association, found no increase in patients' cancer risk. The second study, which ran three weeks 

later in the British Medical Journal, found the risk for developing cancer to be low, but doubled. 

Which conclusion was correct? 

Article 

link: http://online.wsj.com/article/SB10001424052702303916904577377841427001840.html?m 

od=ITP_pageone_0 

Source website: http://online.wsj.com/home-page 

A Cystic Fibrosis Treatment Is Called ‘Game-Changing’ 


A combination of a cystic fibrosis drug and an experimental treatment for the disease, both 

developed by Vertex Pharmaceuticals, led to significantly improved breathing ability in a 

midstage study. The data suggested that Vertex could have a multibillion-dollar franchise in 

treating cystic fibrosis, a life-threatening genetic disorder that affects about 70,000 people 

worldwide. 

Article link: http://www.nytimes.com/2012/05/08/business/vertexs-cystic-fibrosis-therapy-iscalledgame-changing.html?_r=2 

Source website: http://www.nytimes.com/ 

One in eight teens misuses prescription painkillers 


One in eight older teens has used powerful painkillers when they weren't prescribed -- and many 

of them start misusing the medications earlier than was previously assumed, according to new 

research. The findings are based on two nationally-representative surveys that asked teenagers 

about their recent or lifetime use of prescription painkillers, which include drugs such as 

oxycontin and codeine. 

Article link: http://www.reuters.com/article/2012/05/07/us-painkillersidUSBRE8460ZV20120507 


Pfizer Arthritis Pill Raises Safety Concerns, FDA Staff Says 


Pfizer Inc.’s experimental pill to treat rheumatoid arthritis, one of the company’s leading drug 

candidates, raised “serious safety concerns” in trials, U.S. regulators said today. The pill, 

tofacitinib, carried increased risks of serious infections and malignancies, in particular a higher 

chance of lymphoma, Food and Drug Administration staff wrote. The agency released the report 

ahead of a May 9 meeting of FDA medical advisers who will review tofacitinib’s benefits and 

risks. 

Article link: http://www.bloomberg.com/news/2012-05-07/pfizer-s-arthritis-pill-raisessafetyconcerns-fda-staff-says.html 


13

Many drug labels missing dose, safety info for kids 


Half of drug labels don't have information on the medication's safety and proper dosing in kids, 

according to a new study from researchers at the U.S. Food and Drug Administration. The 

finding, from an evaluation of over 500 drug labels in 2009, is an improvement over the one in 

five labels that had pediatric information in 1975 -- but it still leaves a lot of questions, 

researchers said. 

Article link: http://www.reuters.com/article/2012/05/08/us-drug-labelssafetyidUSBRE84717M20120508 


Gilead’s Truvada Pill Is Safe for HIV Prevention 


Gilead Sciences Inc.’s pill Truvada was safe and effective when used to protect uninfected 

people from getting HIV, U.S. regulators said in a report indicating the main concerns are when 

and how it should be used. Truvada was “well tolerated” and its ability to reduce the risk of 

infection was backed by two studies, the Food and Drug Administration staff said in a report 

today. Gilead, based in Foster City, California, is seeking to sell the drug as the first pill to keep 

people from becoming infected. 

Article link: http://www.bloomberg.com/news/2012-05-08/gilead-hiv-pill-shown-safe-instudies-fdastaff-report-says.html 


Regeneron’s Arcalyst Fails to Win Panel Backing for Gout 


Regeneron Pharmaceuticals Inc. failed to win the backing of advisers to the U.S. Food and Drug 

Administration to expand the use of the autoinflammatory drug Arcalyst to include patients 

undergoing gout treatments. An advisory panel voted 11-0 against approval of the injection, 

citing inadequate safety data, at a meeting today in Silver Spring, Maryland. The FDA isn’t 

required to follow the panel’s recommendations. Arcalyst was cleared for sale in February 2008 

to treat a rare genetic autoinflammatory disease. 

Article link: http://www.businessweek.com/news/2012-05-08/regeneron-s-arcalyst-fails-to-winpanelbacking-for-gout 


Persistent Concerns About Lorcaserin (Lorqess) From FDA Reviewers 


The FDA has posted briefing documents for Thursday’s meeting of the Endocrinologic and 

Metabolic Drugs Advisory Committee to reconsider the new drug application for lorcaserin 

(Lorqess, Arena). The same panel recommended against approval of the drug in September 

2010, citing weak efficacy and safety concerns. 

Article link: http://www.forbes.com/sites/larryhusten/2012/05/08/persistent-concernsaboutlorcaserin-lorqess-from-fda-reviewers/?feed=rss_home 

Source website: http://www.forbes.com/ 

14

Testosterone supplements may help male weight loss 


Testosterone injections helped obese men with a hormone deficiency to lose weight. Older 

obese men could shift excess weight by taking testosterone supplements, suggest findings 

announced at the European Congress on Obesity. In a study, hormone-deficient men were given 

testosterone supplements in a similar way to HRT for older women. Men lost an average of 

16kg over five years when testosterone levels were increased back to normal. 

Article link: http://www.bbc.co.uk/news/health-17992440 

Source website: http://www.bbc.co.uk/ 

J&J seeks Xarelto approval to prevent stent clots 


Johnson & Johnson asked U.S. regulators to approve use of its Xarelto blood thinner for a new 

use, in reducing the risk of blood clots developing in heart stents. The U.S. drugmaker said it 

asked the U.S. Food and Drug Administration to approve the new use in patients with acute 

coronary syndrome, a group of conditions that include heart attacks and chest pain caused by 

clogged coronary arteries. 

Article link: http://www.reuters.com/article/2012/05/09/us-jj-xarelto-idUSBRE8480SI20120509 


Biogen MS drug application accepted by U.S., EU regulators 


Both U.S. and European regulators have accepted for review Biogen Idec's application for 

experimental multiple sclerosis drug BG-12. The pill is seen by some Wall Street analysis as 

having the potential to become the world's leading treatment for the chronic, disabling disease 

that attacks the central nervous system and can lead to numbness, paralysis and loss of vision. 

Article link: http://www.reuters.com/article/2012/05/09/us-biogen-idUSBRE8481F120120509 


Gilead’s Quad Pill Raises Kidney Questions, FDA Says 


Gilead Sciences Inc.’s experimental HIV pill Quad may need additional monitoring because of 

kidney damage seen in studies, U.S. regulators said. The four-in-one combination pill from 

Gilead, the largest maker of AIDS drugs, had a “generally acceptable” safety profile and retained 

more patients than standard treatments, Food and Drug Administration staff said in a report 

today. The agency asked advisers whether patients taking the drug should undergo extra testing 

to monitor for kidney complications. 

Article link: http://www.bloomberg.com/news/2012-05-09/gilead-s-quad-pill-raises-questionson-kidney-safety-fda-says.html 


New Drug Shows Promise for Myeloma Patients 


Studies found lenalidomide lengthened time disease did not worsen, but risk of second cancers 

was doubled. Three new studies confirm that the drug lenalidomide can significantly lengthen 

the time that people with multiple myeloma experience no worsening of their disease, either after 

having a stem cell transplant or getting chemotherapy. However, what isn't clear from the 

15

studies is whether or not the improved "progression-free" survival time will translate to a longer 

overall survival. 



Pfizer’s Arthritis Pill Backed by U.S. FDA Advisory Panel 


Pfizer Inc.’s experimental pill to treat rheumatoid arthritis, one of the drugmaker’s leading 

therapy candidates, should be approved by U.S. regulators, an advisory panel said. Pfizer, the 

world’s largest drugmaker, is seeking to sell the pill, tofacitinib, for patients who don’t respond 

to other rheumatoid arthritis treatments. A panel of advisers to the Food and Drug 

Administration recommended in an 8-2 vote today in Silver Spring, Maryland, that the agency 

clear the drug for sale. The FDA isn’t required to follow the panel’s advice. 

Article link: http://www.bloomberg.com/news/2012-05-09/pfizer-s-arthritis-pill-backed-by-u-sfdaadvisory-panel.html 


Bone Drugs May Not Help Women Long Term, FDA Review Says 


Bone-strengthening drugs such as Merck & Co’s Fosamax, used to treat and prevent osteoporosis 

in older women, may have little long-term benefit, U.S. regulators said in an analysis of 

previously released studies. Research from the Food and Drug Administration, published 

yesterday in the New England Journal of Medicine, renews a debate about whether use of the 

drugs after more than three to five years provides any protection against the risk of bone 

fractures. The agency has been evaluating the safety of the treatments since 2007 and last 

September an advisory panel suggested changes to the medicines’ labels to show the 

effectiveness may wear off over time. 

Article link: http://www.businessweek.com/news/2012-05-10/bone-drugs-may-not-helpwomen-longterm-fda-review-says 


Arena obesity pill wins over U.S. advisers 


An experimental obesity pill from Arena Pharmaceuticals Inc won the support of U.S. advisers 

on Thursday, as public health advocates push for new solutions to the nation's growing obesity 

epidemic. A panel of outside experts to the Food and Drug Administration voted 18 to 4 to 

recommend approval of lorcaserin, bringing the drug a step closer to U.S. approval as one of the 

first new weight-loss treatments in over a decade. 

Article link: http://www.reuters.com/article/2012/05/11/us-fda-arena-idUSBRE8491I120120511 


FDA panel backs Gilead's Truvada to prevent HIV 


A U.S. Food and Drug Administration panel of outside experts recommended Gilead Sciences 

Inc's Truvada as a treatment for preventing HIV infection among people at risk for contracting 

AIDS, including homosexual and bisexual men. In a move that could lead to a new milestone 

for treatment in the evolution of the worldwide AIDS epidemic, the FDA advisory committee 

16

voted 19-3 to endorse the drug's use for controlling HIV infection among the highest risk group - 

men who have sex with men. 

Article link: http://www.reuters.com/article/2012/05/11/us-usa-aidstruvadaidUSBRE84A00C20120511 


FDA Review Positive on Quad Pill for HIV 


A single-pill, once-daily regimen for HIV treatment, which includes two investigational drugs, 

did as well in clinical trials as two widely used regimens, FDA staff reviewers reported in 

documents prepared for an advisory committee review. On Friday, the agency's antiviral 

advisory committee will consider the so-called quad pill, which includes two widely used anti- 

HIV drugs – emtricitabine and tenofovir – as well as a novel integrase inhibitor, elvitegravir, and 

a new pharmacokinetic booster dubbed cobicistat. 

Article link: http://www.medpagetoday.com/HIVAIDS/HIVAIDS/32610 


Propofol drug shortages: The economic problem of a generic injectable 


Propofol might best be known as the anesthetic Michael Jackson used inappropriately as a 

sleeping aid. Administered properly, the drug widely is used in hospitals to sedate patients. It 

also happens to be part of an industry wide drug shortage affecting hospitals throughout the 

country. 

Article link: http://medcitynews.com/2012/05/propofol-drug-shortages-the-economic-problemof-ageneric-injectable/?edition=pharmaceuticals 

Source website: http://medcitynews.com/?edition=pharmaceuticals 

J&J opens up Doxil rationing on 'limited' new supply 


After months of restricting Doxil treatment to current patients, Johnson & Johnson has opened 

up its rationing program to new ones. A limited supply of the scarce treatment, used to treat 

ovarian and other cancers, has opened up, the company tells Dow Jones. The shortage arose 

after manufacturing problems at J&J's sole supplier, Ben Venue Laboratories, forced the 

company to stop production at an Ohio plant. J&J since has worked with FDA to release Ben 

Venue's stock of Doxil, and the FDA separately allowed temporary imports of Sun Pharma's 

Lipodox, a similar drug not yet approved in the U.S. 

Article link: http://www.fiercepharma.com/story/jj-opens-doxil-rationing-limited-newsupply/2012-05-10 

Source website: http://www.fiercepharma.com/ 

Heart Procedure More Effective Than Drug for Erratic Rate 


A procedure that destroys part of the cardiac tissue responsible for the most common type of 

heart rhythm disorder is more effective than drug therapy at keeping the erratic rate in check, a 

study found. The results presented at the Heart Rhythm Society meeting in Boston suggest the 

approach known as cardiac ablation should be considered as an initial treatment for atrial 

fibrillation, said lead researcher Carlos Morillo from Hamilton Health Sciences-McMaster 

17

University in Canada. It’s now used for patients who don’t benefit from standard drug therapy, 

he said. 

Article link: http://www.bloomberg.com/news/2012-05-11/heart-procedure-more-effective-thandrugfor-erratic-rate.html 


FDA says unsure if Novartis MS pill caused deaths 


Health regulators said on Monday they could not definitively link Novartis AG's multiple 

sclerosis pill Gilenya with the deaths of people who took the drug. The Food and Drug 

Administration said the deaths included a patient with extensive brainstem lesions from multiple 

sclerosis who died of unknown causes within 24 hours of taking the drug. Other deaths were 

linked to cardiovascular issues. 

Article link: http://www.chicagotribune.com/health/sns-rt-us-novartisbre84d13r- 

20120514,0,6256990.story 

Source website: http://www.chicagotribune.com/health/ 

ASCO Preview: Eight Cancer Drugs to Watch at the Big Show 


The pistons of the biggest publicity engine in cancer R&D will start firing this week. It’s time to 

behold the annual rite of the American Society of Clinical Oncology (ASCO) meeting, the 

biggest event for showing off what’s new and interesting in the treatment of cancer. 

Article link: http://www.xconomy.com/national/2012/05/14/asco-preview-eight-cancer-drugstowatch-at-the-big-show/ 

Source website: http://www.xconomy.com/ 

Orchestrating drug management (American College of Physicians annual scientific 

meeting) 


Managing medications is becoming more complicated due to the aging population, use of opioids 

for chronic pain and increased FDA drug safety messages. Before starting each office visit, 

geriatrician Holly M. Holmes, MD, reviews the medications documented in her patients’ medical 

records. The list often includes more than a dozen prescription drugs, over-the-counter 

medications and herbal supplements. Many of the substances interact. Most have potentially 

negative side effects. 

Article link: http://www.ama-assn.org/amednews/2012/05/14/hlsa0514.htm 

Source website: http://www.ama-assn.org/amednews/ 

FDA Panel Says Yes to Home HIV Test 


An FDA advisory committee has voted 17-0 to recommend approval for the OraQuick In-Home 

HIV test. If approved, it will be the first over-the-counter home HIV test. About 2.8 million 

people would use the OraQuick In-Home HIV Test, made by OraSure Technologies, each year, 

an FDA reviewer estimated. The review projected that the home-use test would lead to 45,000 

new positive test results and could avert more than 4,000 HIV transmissions in a year. 

Article link: http://www.medpagetoday.com/HIVAIDS/HIVAIDS/32713 


18

New Drug Trial Seeks to Stop Alzheimer’s Before It Starts 


In a clinical trial that could lead to treatments that prevent Alzheimer’s, people who are 

genetically guaranteed to develop the disease — but who do not yet have any symptoms — will 

for the first time be given a drug intended to stop it, federal officials announced Tuesday. 

Article link: http://www.nytimes.com/2012/05/16/health/research/prevention-is-goal-ofalzheimersdrug-trial.html?_r=2 


Asthma Cases Reach New High 


Asthma prevalence reached its highest level ever in 2010 -- 8.4% of the population, up from 

7.3% in 2001, according to the CDC. That translates into 18.7 million adults and 7 million 

children who had been diagnosed with asthma and still had the condition in 2010, the agency 

said in a report called Asthma's Impact on the Nation. 

Article link: http://www.medpagetoday.com/AllergyImmunology/Asthma/32703 


Plavix Set to Lose Patent Protection 


For more than a decade, cardiologists treating patients who have had a heart attack have 

routinely scribbled one drug onto their prescription pads: clopidogrel bisulfate, better known as 

Plavix. “It’s a mainstay,” said Dr. Steven Nissen, chairman of cardiovascular medicine at the 

Cleveland Clinic. Before Plavix arrived in 1997, aspirin was the standard treatment for 

preventing blood clots that led to heart attacks and stroke. Combining aspirin with Plavix, 

though, “tremendously improved” the results, Dr. Nissen said. 

Article link: http://www.nytimes.com/2012/05/17/business/plavix-set-to-lose-patentprotection.html 


Lundbeck Sees Lower Libido Risk With New Antidepressant 


H. Lundbeck’s experimental antidepressant may appeal to patients unhappy with the sexual, 

weight- and sleep-related side effects that can occur with existing treatments. The Danish 

company this week said LU AA21004 showed statistically significant results in eight of 10 latestage 

studies that will support regulatory filings in the U.S. and Europe this year. The drug 

addresses “a huge unmet need” as more than 40 percent of patients stop taking available 

medications because of side effects or because they don’t feel much better, Chief Executive 

Officer Ulf Wiinberg said in an interview in London today. 

Article link: http://www.bloomberg.com/news/2012-05-16/lundbeck-sees-lower-libido-riskwith-newantidepressant.html 


Targeted Cancer Drugs With Punch: The Next Big Class of Antibodies 


One of the big dreams in biotech over the past 35 years has been to make drugs that work like 

“smart bombs” by destroying tumors while minimizing collateral damage. Scientists have 

19

learned this is no easy thing, but now that a couple of these types of drugs have been shown to 

work, a new wave of companies is emerging to see if they can finally turn this vision into reality. 

Article link: http://www.xconomy.com/national/2012/05/16/targeted-cancer-drugs-with-punchthenext-big-class-of-antibodies/ 

Source website: http://www.xconomy.com/ 

Doubt Cast on the ‘Good’ in ‘Good Cholesterol’ 


The name alone sounds so encouraging: HDL, the “good cholesterol.” The more of it in your 

blood, the lower your risk of heart disease. So bringing up HDL levels has got to be good for 

health. Or so the theory went. Now, a new study that makes use of powerful databases of 

genetic information has found that raising HDL levels may not make any difference to heart 

disease risk. People who inherit genes that give them naturally higher HDL levels throughout life 

have no less heart disease than those who inherit genes that give them slightly lower levels. If 

HDL were protective, those with genes causing higher levels should have had less heart disease. 

Article link: http://www.nytimes.com/2012/05/17/health/research/hdl-good-cholesterol-foundnot-tocut-heart-risk.html?_r=1 


Popular Antibiotic May Raise Risk of Sudden Death 


A new study finds that a widely used antibiotic, azithromycin, may increase the likelihood of 

sudden death in adults, especially those who have heart disease or are at high risk for it. The 

increased odds of death are small, but significant enough that the authors of the study say doctors 

should consider prescribing a different drug, like amoxicillin, for high-risk patients who need 

antibiotics. People at high risk include those with heart failure, diabetes or a previous heart 

attack, and those who have undergone bypass surgery or have had stents implanted. In such 

patients, the drug may cause abnormal heart rhythms that can be fatal. Just how the drug might 

disrupt heart rhythm is not known, the researchers said. 

Article link: http://www.nytimes.com/2012/05/17/health/research/popular-antibiotic-may-raiseriskof-sudden-death.html?_r=2 


Study Shows MS Patients at Most Risk for Drug-Linked Brain Illness 


Small number of Tysabri users develop rare but potentially fatal infection. Drug company 

researchers say they've determined which multiple sclerosis patients are most vulnerable to 

developing a rare brain infection while taking a powerful drug called Tysabri (natalizumab). 



Roche melanoma drug extends life more than a yr-study 


Roche's new drug for advanced melanoma, Zelboraf, on average helped patients with the deadly 

disease live for more than a year, according to data from a late-stage trial. The results from an 

abstract, or brief summary, of the study showed that Zelboraf led to a median overall survival of 

13.2 months compared with 9.6 months for those who received dacarbazine chemotherapy. That 

20

translates into a 38 percent reduction in the risk of death from the disease, researchers said. 

Article link: http://www.reuters.com/article/2012/05/16/us-cancer-rochemelanomaidUSBRE84F1FC20120516 


J&J drug shows promise in high-risk prostate cancer 


Adding Johnson & Johnson's advanced prostate cancer drug, Zytiga, to hormone therapy before 

surgery has been shown for the first time to eradicate tumors in some men with high-risk forms 

of the disease. The mid-stage trial found that six months of treatment with the combination 

therapy completely or nearly eliminated the cancer in a third of patients, all of whom had 

localized, aggressive cancer. 

Article link: http://www.reuters.com/article/2012/05/16/us-cancer-jjprostateidUSBRE84F1FE20120516 


Doctors often unfamiliar with long-term chemo risks 


* Few doctors could name main risks from common drugs-study 

* US survey shows need for better primary doctor education 

Many of the 12 million Americans who have beaten cancer get routine care from primary care 

doctors, but a new survey suggests the vast majority of these physicians have very little 

knowledge about the long-term side effects these patients face. 

Article link: http://www.reuters.com/article/2012/05/16/cancer-survivorsidUSL1E8GGRW420120516 


Pfizer Lung Drug Stops Deadly Child Cancers in Study 


Pfizer Inc.’s Xalkori, a drug that targets lung cancer caused by a gene defect, wiped out all signs 

of malignancy in some children with different tumor types, in a study that proves aiming 

treatment at genes rather than disease sites may be more effective. 

Article link: http://www.businessweek.com/news/2012-05-16/pfizer-lung-drug-stops-deadlychildcancers-in-study 


Novartis lung drug superior to placebo over 1 year 


A Novartis experimental lung drug to treat smokers' cough was superior to a placebo in 

improving lung function over a one-year period and had similar efficacy to a rival drug from 

Pfizer and Boehringer Ingelheim, the Swiss drugmaker said on Thursday. The Phase III 

GLOW2 trial showed a 50 mcg once-daily dose of NVA237 improved lung function, symptom 

relief and quality of life over a one-year period in patients with chronic obstructive pulmonary 

disease (COPD), commonly referred to as smokers cough, compared with a placebo. 

Article link: http://www.chicagotribune.com/health/sns-rt-us-novartisbre84g0e0- 

20120517,0,1014099.story 

Source website: http://www.chicagotribune.com/ 

21

Abuse of opioid drugs hits all-time high 


The headlines are startling: 

• Some 210 million prescriptions were written last year for opioid medications, Nora Volkow, 

head of the National Institute on Drug Abuse, told CBS "60 Minutes." 

• In 2009, there were more than 13,000 babies born with neonatal abstinence syndrome after 

being exposed to opioids in utero, a three-fold increase since 2000, according to an article just 

published online by The Journal of the American Medical Association. 

Article link: http://www.post-gazette.com/stories/news/health/abuse-of-opioid-drugs-hits-alltimehigh-636405/?p=0 

Source website: http://www.post-gazette.com/ 

Trial Supports Earlier Use of a Prostate Cancer Drug 


A new drug used to treat advanced prostate cancer may also help men if used early in the course 

of the disease, before an operation, researchers reported Wednesday. In a small clinical trial, six 

months of treatment with the drug, Johnson & Johnson’s Zytiga, added to standard therapy, 

eliminated or nearly eliminated tumors in about one-third of men whose disease had not yet 

spread beyond the prostate gland but was considered likely to do so. 

Article link: http://www.nytimes.com/2012/05/17/health/zytiga-a-prostate-cancer-drug-doeswell-intrial.html?_r=2&ref=drugspharmaceuticals 


Glaxo’s Melanoma Cocktail Slows Cancer in Study 


GlaxoSmithKline’s combination of two experimental melanoma medicines slowed the progress 

of cancer with few skin complications in an early study, suggesting the combo may not have as 

many side effects as existing single- drug treatments. 

Article link: http://www.businessweek.com/news/2012-05-16/glaxo-s-melanoma-cocktailslowscancer-in-study 


Drugs Help Tailor Alcoholism Treatment 


If alcoholism is a disease, is there hope of finding the cure in a pill? Yes and no. Having mapped 

the physical changes the brain undergoes with years of habitual drinking, researchers in recent 

years have discovered a handful of promising — and some say underused — drugs that, 

combined with therapy, help alcoholics break the cycle of addiction. 

Article link: http://www.nytimes.com/2012/05/22/health/tailoring-treatments-foralcoholics.html?_r=1 


More Research Points to Long-Term Ills With Bone Drugs 


Bisphosphonates used for osteoporosis raise risk of rare fractures over time, study says. Adding 

more weight to concerns about possible long-term dangers of osteoporosis drugs, a new study 

finds that people who take the drugs, known as bisphosphonates, may be at increased risk for 

22

atypical fractures of the thigh bone (femur). 



Dr. Reddy’s Announces the Launch of Over-the-Counter Lansoprazole Delayed-Release 

Capsules 


Dr. Reddy’s Laboratories announced today that it has launched over-the-counter (OTC) 

Lansoprazole delayed-release capsules in the U.S. market on May 18, 2012, following Dr. 

Reddy’s ANDA approval by the United States Food & Drug Administration (USFDA). 

Article link: http://finance.yahoo.com/news/dr-reddy-announces-launch-over-042100403.html 

Source website: http://finance.yahoo.com/ 

UPDATE 3-FDA staff sends mixed message on J&J drug Xarelto 


* FDA staff cites missing data on drug studies 

* FDA's clinical reviewer recommends approval 

* FDA advisers to vote on Xarelto on Wednesday 

* J&J shares rise 0.2 pct, Bayer up 2.3 pct 

U.S. drug reviewers had mixed opinions about whether Johnson & Johnson blood thinner 

Xarelto reduced the risk of new heart attacks and strokes in people with heart problems, setting 

the stage for heated debate by outside experts later this week. 

Article link: http://www.reuters.com/article/2012/05/21/fda-johnsonxareltoidUSL1E8GL4GA20120521?type=companyNews&feedType=RSS&feedName=compan 

yNews&rpc=43 


Abbott’s New Use for Top Drug Humira Delayed by U.S. 


Abbott Laboratories’ bid to expand use of its best-selling arthritis treatment Humira to ulcerative 

colitis patients is being delayed by U.S. regulators. 

Article link: http://www.businessweek.com/news/2012-05-22/abbott-s-new-use-for-top-drughumiradelayed-by-u-dot-s-dot 


Asthma Meds May Be Linked to Irregular Heartbeat 


Early study found more arrhythmias in young people on certain inhalers. New research suggests 

that young asthma patients who use drugs known as inhaled anticholinergics -- such as 

ipratropium [Atrovent] -- could be more likely than others to suffer from potentially dangerous 

irregular heartbeat. 



Will Lundbeck's New Antidepressant Be a Major New Drug? 


There are a variety of medications available to treat depression, the most popular being selective 

23

serotonin re-uptake inhibitors (SSRIs) such as Prozac, Zoloft and Paxil. While effective, these 

and other antidepressants are not ideal. In general, the success rate for these drugs is on the order 

of 50%. In addition, weeks of treatment are needed before the beneficial effects begin to take 

effect, thus prolonging a patient’s medical problems. Finally, these drugs have a variety of sideeffects 

that impact one’s quality-of-life. 

Article link: http://www.forbes.com/sites/johnlamattina/2012/05/22/will-lundbecksnewantidepressant-be-a-major-new-drug/ 

Source website: http://www.forbes.com/ 

Takeda drug impresses in ulcerative colitis study 


More than 40 percent of patients with moderate to severe ulcerative colitis achieved clinical 

remission from the debilitating condition after a year of taking an experimental drug developed 

by Japan's Takeda Pharmaceutical Co, according to data from a pivotal late-stage trial. 

Article link: http://www.reuters.com/article/2012/05/22/us-takeda-colitisidUSBRE84L0VR20120522 

Source website: http://www.ama-assn.org/amednews/ 

Recalls 

PRODUCT (Class I) 

1) Mince Belle Dietary Supplement, 30 Capsules. Recall # D-1347-2012; 

2) Perfect Men Dietary Supplement, 10 Capsules. Recall # D-1348-2012; 

3) EVERLAX Dietary Supplement, 30 capsules. Recall # D-1349-2012; 

4) EVER Slim Dietary Supplement, 30 capsules. Recall # D-1350-2012; 

5) Herbal Drink Acai-man mangosteen Dietary Supplement, Contents 16.6 fl oz. Recall # D- 

1351-2012; 

6) EVER SLIM Shake Mix Dietary Supplement Strawberry, Net Weight 17.6 oz. Recall # D- 

1352-2012; 

7) EVER SLIM Shake Mix Dietary Supplement Chocolate, Net Weight 17.6 oz. Recall # D- 

1353-2012 

CODE 

1) Lot #: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10- 

021, and HPCMB/10-016; 

2) Lot #: HPCPM/002; 

3) Lot #: HPCEX/074, HPCEX/076, HPCEX/072, and HPCEX/032; 

4) Lot #: HPCES-079, HPCES-070, HPCES-071, and HPCES/038; 

5) Lot #: HPJAC/004; 

6) Lot #: HPESSF/168; 

7) Lot #: HPESSC/061 

RECALLING FIRM/MANUFACTURER 

Recalling Firm: Healthy People, Irwindale, CA, by press release on February 3, 2012. 

Manufacturer: Healthy Labs S. de R. L. de C. V., Irapuato, Mexico. Firm initiated recall is 

ongoing. 

REASON 

Marketed Without an Approved NDA/ANDA: FDA laboratory analyses found the products to 

24

contain Sibutramine, an appetite suppressant that was withdrawn from the market in October 

2010 for safety reasons, making these products unapproved new drugs. 

PRODUCT (Class II) 

MethylPREDNISolone Tablets, USP, 4 mg, 1 Unit For Dose Pack, 21 Tablets, Rx only, NDC 

0603-4593-15. Recall # D-1326-2912 

CODE 

Lot Number: S003M11, Exp 9/13 


Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, by letter 

beginning on April 4, 2012. Firm initiated recall is ongoing. 

REASON 

Labeling: Label-Mix Up: One unit dose package of Prednisolone, USP, 4 mg, was found with the 

back of the blister card which has the dosing instructions rotated 180 degrees such that there is 

one tablet in the row for Day 1 (versus 6 tablets) and six tablets in the row for Day 6 (versus 1 

tablet). 


Little Fevers Children's Fever/Pain Reliever (acetaminophen) liquid, 160 mg/ 5 mL, Natural 

Cherry Flavor, 4 fl. oz. (118 mL) bottle; UPC Code: 7 56184 10124 7. Recall # D-1327-2012 

CODE 

Lot #: 574-1913, 574-1938, 574-1943, Exp 09/12; 574-1979, 574-1980, 574-2008, Exp 10/12; 

574-2009, Exp 11/12 


Recalling Firm: Medtech Products, Inc., Irvington, NY, by letters dated April 10, 2012. 

Manufacturer: Guardian Drug Co. Inc.m Dayton, NJ. Firm initiated recall is ongoing. 

REASON 

Resuspension Problems: Little Fevers Children's Fever/Pain Reliever (acetaminophen) Liquid, 

160 mg/ 5 mL, Dye-Free Natural Cherry Flavor because of crystallization identified as 

acetaminophen may come out of suspension in the products. 


1) Tetracycline HCl Capsules USP, 250 mg, Rx only, packaged in a) 100-count capsules per 

carton (NDC 0172-2416-10), UPC 3 0172-2416-10 1, packaged in 10 cards of 10 x 1-count 

capsules per blister (NDC 0172-2416-00); b) 100-count bottles (NDC 0172-2416-60), UPC 3 

0172-2416-60 6; and c) 1000-count bottles (NDC 0172-2416-80), UPC 3 0172-2416-80 4. Recall 

# D-1330-2012; 

2) Tetracycline HCl Capsules USP, 500 mg, Rx only, packaged in a) 100-count capsules per 

carton (NDC 0172-2407-10), UPC 3 0172-2407-10 1, packaged in 10 cards of 10 x 1-count 

capsules per blister (NDC 0172-2407-00); b) 100-count bottles (NDC 0172-2407-60), UPC 3 

0172-2407-60 4; and c) 1000-count bottles (NDC 0172-2407-80), UPC 3 0172-2407-80 2. Recall 

# D-1331-2012 

CODE 

1) Lot #: a) 317297, Exp 08/12; 34000390A, Exp 11/12; 34002112A, Exp 03/13; b) 702101, Exp 

04/12; 33401717A, Exp 05/12; 33402259A, Exp 08/12; 33402394B, Exp 10/12; 315037, 

316165, Exp 05/13; 317237, 115032A, Exp 08/13; 34000391A, 34000392A, Exp 11/13; 

34002112B, 34002113A, Exp 03/14; 34002114A, Exp 04/14; c) 33401718A, Exp 05/12; 

25

33401719A, Exp 06/12; 33402144A, Exp 07/12; 33402258A, 33402259B, 702950, 702951, Exp 

08/12; 33402392A, 33402393A, Exp 10/12; 316512, 316513, Exp 05/13; 317238, 317338, 

115031B, Exp 08/13; 34000390B, Exp 11/13; 34002110A, 34002111A, Exp 02/14; 34002115C, 

Exp 04/14; 34000393A, Exp 11/14; 

2) Lot #: a) 115767B, Exp 10/12; 34000663A, Exp 01/13; 34002104A, Exp 04/13; b) 

33401714A, Exp 05/12; 33402143A, 702953, Exp 07/12; 33402422A, 33402423A, Exp 08/12; 

33402426A, Exp 09/12; 33402427A, 33402451A, 33402545A, Exp 10/12; 702836, 702954, Exp 

11/12; 33402664A, Exp 12/12; 315857, 315858, 315859, 315958, 315959, Exp 04/13; 315856, 

Exp 05/13; 316709, 316991, 316992, 316993, 317491, Exp 07/13; 317601, 317619, 317620, 

317621, 317622, Exp 09/13; 115764A, 115765A, Exp 10/13; 34000662A, 115768A, 

34000663B, 34000664A, 34000667A, Exp 01/14; 34002095A, 34002100B, 34002101A, Exp 

03/14; 34002108B, Exp 05/14; c) 33401715A, Exp 05/12; 33401716A, Exp 06/12; 33402424A, 

33402425A, Exp 09/12; 33402450A, Exp 10/12; 33402546A, 33402550A, Exp 11/12; 

33402665A, Exp 12/12; 316225, 316785, Exp 04/13; 315863, 316093, 316094, 316511, Exp 

05/13; 316994, 316995, 316996, Exp 07/13; 317236, 317813, 317814, 317815, Exp 09/13; 

115766A, 115767A, Exp 10/13; 34000665A, 34000666A, Exp 01/14; 34002096A, 34002098A, 

34002099A, 34002102A, Exp 03/14; 34002104C, 34002105B, 34002106B, Exp 04/14 


Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville. PA, by letter on February 9, 2012. 

Manufacturer: Barr Laboratories, Inc. (div. Of Teva), Forest, VA. Firm initiated recall is 

ongoing. 

REASON 

Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. 


Campral (acamprosate calcium) Delayed-Release Tablets, 333 mg, packaged in a) 30-day supply 

(3 blister cards x 60 tablets) 180 tablets per carton, NDC 0456-3330-60, UPC 3 0456-3330-60 5; 

b) 10 x 10 blister cards (100 tablets) per carton hospital unit dose, NDC 0456-3330-63, UPC 0 

04563 33063 5; and c) 7-day supply (1 blister card x 42 tablets) per Patient Starter Kit, 

professional sample blister pack, NDC 0456-3330-42; Rx only. Recall # D-1332-2012 

CODE 

Lot #: a) 1069783, Exp 04/30/12; 1079546, 1082538, Exp 01/31/13; b) 1071614, Exp 04/30/12; 

1072823, Exp 10/31/12; 1077653, 1078959, Exp 01/31/13; and c) 1073308, Exp 10/31/12 


Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by letters dated March 19, 2012. 

Manufacturers: Merck Sante, Semoy, France; 

Forest Pharmaceuticals Inc., Cincinnati OH. 

Firm initiated recall is ongoing. 

REASON 

Failed USP Dissolution Test Requirements: Failing high results for the acid-stage dissolution test 

was obtained at the 18-month test interval. 


1) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Cherry Flavor 160 mg per 5 

mL pain reliever/fever reducer a) 1 fl oz,. 30 mL UPC 011673574095, b) 2 fl oz, 60ml, UPC 

011673574781, c) Twin Pack - 2 fl oz (60ml), UPC 011673574033, d) Twin Pack Promotion - 

26

2 fl oz UPC 011673257424. Recall # D-1335-2012; 

2) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Grape Flavor 160 mg per 5 

mL pain reliever/fever reducer 2 fl oz. 60 mL UPC 011673602781. Recall # D-1336-2012 

CODE 

1) Units: 574-3426 09/2013 574-3427 09/2013 574-3428 09/2013 574-3439 09/2013 574-3445 

09/2013 574-3446 09/2013 574-3502 10/2013 574-3669 11/2013 574-3670 12/2013 574-3671 

12/2013 574-3691 12/2013 574-3692 12/2013 574-3714 12/2013 574-3715 12/2013 574-3732 

12/2013 374-3760 01/2014 574-3761 01/2014; 

2) Unit: 602-3716 12/2013 


Guardian Drug Co. Inc., Dayton, NJ, by letter on April 16, 2012 and issued a web site 

notification on April 24, 2012. Firm initiated recall is ongoing. 

REASON 

Mislabeling: Infant acetaminophen suspension product labeling was missing the statement 

"Under 2 years ask doctor" and the weight-based dosing of the label provides for doses that are 

higher than what has been recommended for children 2 years and older. 


Kit for the Preparation of Technetium Tc99m Pyrophosphate Injection, a) 5-count multidose 

vials per box (NDC 45567-0060-1), b) 30-count multidose vials per box (NDC 45567-0060-2), 

Rx only. Recall # D-1342-2012 

CODE 

Lot #: 220053, Exp 06/12 


Pharmalucence, Inc., Bedford, MA, by telephone and/or letter dated May 2, 2012. Firm initiated 

recall is ongoing. 

REASON 

Lack of assurance of sterility - Raw material used in the manufacture of the finished product did 

not meet specification for endotoxins. 


1) SYMPT-X Glutamine Powder Regular Formula (glutamine), 480 gram jar, a) Product code 

2L5100: cartons of 12 jars each; b) Product code 2L5011E: single jar cartons for direct 

consumers only; Rx only, Made in USA; NDC 0338-9170-91. Recall # D-1345-2012; 

2) SYMPT-X Glutamine Powder Regular Formula (glutamine), 15 gram packets containing 10 

grams Glutamine, 60-count packets per box, Rx only, Made in USA; NDC 0338-9177-91; 

Product code 2L5107. Recall # D-1346-2012 

CODE 

1) Lot #: 0061E9, Exp 01/12; 0093G9, Exp 03/12; 0175B0, Exp 10/12; 0123F0, Exp 01/13; 

0284G0, Exp 02/13; 0197J0, Exp 05/13; 0449D1, Exp 11/13; and 0145F1, Exp 12/13; 

2) Lot #: 0319G9, Exp 02/12 


Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated April 24, 2012. 

Manufacturer: Garden State Nutritionals, Div. Vitaquest International, LLC, West Caldwell, NJ. 

Firm initiated recall is ongoing. 

REASON 

Labeling: Label w/Wrong or Incorrect EXP Date: The SYMPT-X Glutamine Powder is labeled 

27

with an incorrect expiry date, past the recommended shelf life from the date of manufacture. 


1) Topiramate Tablets, 100 mg, a) 60-count tablets per bottle (NDC 0093-7219-06, UPC 3 0093- 

7219-06 4), b) 1000-count tablets per bottle (NDC 0093-7219-10, UPC 3 0093-7219-10 1), Rx 

only. Recall # D-1339-2012; 

2) Topiramate Tablets, 50 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7540-10, UPC 

3 0093-7540-10 6. Recall # D-1340-2013; 

3) Topiramate Tablets, 200 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7220-10, 

UPC 3 0093-7220-10 7. Recall # D-1341-2012 

CODE 

1) Lot #: a) 29T097, 29T098, Exp 08/13; b) 29T093, 29T094, 29T096, Exp 07/13; 29T099, Exp 

08/13; 

2) Lot #: 16T023, 16T024, and 16T026, Exp 03/12; 

3) Lot #: 30T044, Exp 06/12; and 30T085, Exp 07/13 


Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 28, 2012. 

Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm initiated recall is 

ongoing. 

REASON 

Impurities/Degradation Products: The specified lots may not meet the impurity specification 

through expiry 


Ovcon 50 (norethindrone and ethinyl estradiol) tablets, USP, 1 mg/50 mcg, a) 3-count blister 

cards of 28 tablets each per carton (NDC 0430-0585-45, UPC 3 0430-0585-45 9), b) 6-count 

blister cards of 28 tablets each per Physician's Sample carton (NDC 0430-0585-95), Rx only. 

Recall # D-1344-2012 

CODE 

Lot #: a) 506964B, Exp 05/12; 509310A, Exp 09/12; 511071A, Exp 12/12; b) 506964C, Exp 

05/12 


Warner Chilcott Company LLC, Fajardo, PR, by letter dated April 3, 2012. Firm initiated recall 

is ongoing 

REASON 

CGMP Deviations: This recall is being initiated as part of the commitments to the response to the 

FDA concerns on lack of full shelf-life stability data supporting 12-months expiry date. 


Product is single dose vials of hepatitis B vaccine. Labeling reads in part: "***ENGERIX-B 20 

mcg/mL NDC 58160-821-01***EACH mL CONTAINS 20 mcg OF HEPATITIS B SURFACE 

ANTIGEN ADSORBED ON 0.5 mg ALUMINUM AS ALUMINUM HYDROXIDE***STORE 

AT 36 - 46 F. SEE USP. DO NOT FREEZE***DIST. BY: GLAXOSMITHKLINE RESEARCH 

TRIANGLE PARK, NC 27709 PRODUCT ID: CLEAR GLASS VIAL 

WHITE/BLACK/ORANGE/TEAL LABEL***NDC 58160-821-01***DISCARD IF FROZEN. 

Recall # B-1088-12 

CODE 

28

NDC 5816082101 (single dose vial); NDC 5816082111 (box of 10 vials). 


Recalling Firm: Normed, Seattle, WA, by letters beginning June 16, 2011. 

Manufacturer: Glaxo Smithkline – Rixensart, Rixensart, Belgium. FDA initiated recall is 

ongoing. 

REASON 

Engerix-B, lacking assurance of proper storage temperatures, was distributed. 


Celestone brand of betamethasone Oral Solution USP, 0.6 mg/ 5 mL, supplied in 4 fluid ounce 

(118 mL) amber glass bottles, Rx only, NDC 0085-0942-05. Recall # D-1354-2012 

CODE 

LOT 9 APR, 100 EXP MAR 12; LOT 9 APR 101, EXP AUG 12; LOT 9 APR 102, EXP SEP 

12; LOT 9 APR 103, EXP NOV 12; LOT 0 APR 100, EXP MAR 13; LOT 0 APR 101, EXP 

JUN 13; LOT 0 APR 102, EXP SEP 13; LOT 0 APR 103, EXP SEP 13 


Merck, Inc., Kenilworth, NJ, by letters on January 23, 2012. Firm initiated recall is ongoing. 

REASON 

Failed Content Uniformity Requirements; potential for dosing variability found during routine 

product stability testing. 

PRODUCT (Class III) 

1) buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, packaged in a) 30-count 

tablets per bottle (NDC 67767-142-30), b) 90-count tablets per bottle (NDC 67767-142-90), c) 

500-count tablets per bottle (NDC 67767-142-05), Rx only. Recall # D-1328-2012; 

2) buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, packaged in a) 30-count 

tablets per bottle (NDC 67767-141-30), b) 90-count tablets per bottle (NDC 67767-141-90), Rx 

only. Recall # D-1329-2012 

CODE 

1) Lot #: a) 759C11, 760C11, 761C11; Exp 01/12; CE0D06A, CE0D07A, CE0D08A, Exp 

04/12; 482K01, CH0D20A, CH0D23A, CH0D25A, CH0D28A, CH0D31A, Exp 07/12; 244K01, 

546K01, 547K01, 553K01, CJ0D05A, CJ0D12A, CJ0D13A, CJ0D14A, CJ0D15A, CJ0D18A, 

Exp 08/12; 332A11, Exp 12/12; b) CE0D09A, Exp 04/12; 481K01, Exp 07/12; 243K01, 

545K01, CJ0D09A, CJ0D11A, Exp 08/12; 248M01, 330A11, Exp 11/12; 333A11, Exp 12/12; c) 

CE0D10A, CE0D11A, CE0D12A, Exp 04/12; CH0D16B, CH0D17B, CH0D18A, CH0D19A, 

CH0D21A, CH0D22A, CH0D24A, CH0D29A, CH0D30A, Exp 07/12; 245K01, Exp 08/12, 

CJ0D23A, CJ0D24A, Exp 09/12; 

2) Lot #: a) 549K01, 584K01, 644L01, 645L01 646L01, 647L01 648L01, CK0D12A, 

CK0D13A, CK0D14A, CK0D15A, CK0D16A, CK0D17A, Exp 01/12; CL0D03A, CL0D04A, 

Exp 02/12; 303M01, Exp 03/12; 476B11, 477B11, 478B11, 479B11, 570B11, 571B11, Exp 

04/12; CF0D01A, CF0D02A, CF0D05A, CF0D21A, CF0D22A, Exp 05/12; CG0D07A, 

CG0D08A, CG0D09A, CG0D12A, CG0D26A, Exp 06/12; CG1D10A, Exp 10/12; 550K01, 

551K01, 552K01, Exp 11/12; b) 548K01, CK0D18A, CK0D19A, CK0D20A, Exp 01/12; 

CL0D01A, CL0D02A, Exp 02/12; 228A11, 229A11, 272M01, 273M01 304M02, CD0D15A, 

CM0D02A, Exp 03/12; 526B11, 553B11, Exp 04/12; CF0D06A, CF0D07A, CF0D08A, 

CF0D23A, CF0D24A, Exp 05/12; CG0D01A, CG0D02A, CG0D03A, CG0D04A, CG0D05A, 

CG0D06A, CG0D10A, CG0D11A, CG0D25A, CG0D27A, CG0D28A; 06/12; CH0D01A, 

29

CH0D02A, CH0D03A, CH0D05B, CH0D06B, CH0D07B, CH0D10B, Exp 07/12 


Recalling Firm: Actavis South Atlantic LLC, Sunrise, FL, by letters on December 27, 2011, 

January 13, 2012 and March 7, 2012. 

Manufacturer: CMIC CMO USA Corp., Cranbury, NJ. Firm initiated recall is ongoing. 

REASON 

Failed USP Dissolution Test Requirements: Out of specification results for dissolution were 

obtained at the 8-hour stability testing point, all other time points at 2, 3, and 16-hours met 

specification. 


Lorazepam Oral Concentrate, USP, 2 mg/mL, Rx Only, 30 mL bottle, NDC 0574-0163-30. 

Recall # D-1333-2012 

CODE 

Lot #s: 2010302121, Exp 07/2012; 2010392922, Exp 09/2012; 2010514031, Exp 12/2012; 

2011084759, Exp 02/2013; 2011145313, Exp 04/2013; 2011235889, Exp 06/2013 


Paddock Laboratories, Inc., Minneapolis, MN, by letter dated April 4, 2012. Firm initiated recall 

is ongoing. 

REASON 

Impurities/Degradation Products: This recall has been initiated due to non-conformance to the 

specification for a specified impurity (Related Compound C) at the 12-month stability test station 


Losartan Potassium Tablets USP, 50 mg, 1000 film coated tablets, NDC 16714-582-03. Recall # 

D-1334-2012 

CODE 

Lot #G00921A EXP AUG 2013 Lot #G00922A EXP AUG 2013 Lot #G00923A EXP AUG 

2013 


Actavis Pharma Manufacturing Private Limited, Kanchipuram, India, by letters dated January 5, 

2012. Firm initiated recall is ongoing. 

REASON 

Presence of Foreign Substance; magnesium stearate excipient used in the product was found to 

be contaminated with zeolite, calcium hydroxide, dibenzoylmethane and Bisphenol A (BPA). 


Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles. Recall # D- 

1337-2012 

CODE 

Lot # Exp Date: F48768 02/2013; F71099 03/2013; F74724 03/2013; 42281 03/2013; 42284 

03/2013; 42285 03/2013; 42288 03/2013; 42291 03/2013; 1355CB 03/2013; 1712FR 

03/2013;1412RR 03/2013 ; 1612RR 03/2013; 2010KA 03/2013 ; 1362KA 03/2013; 1361KA 

03/2013 ; 1712AR 03/2013; 1612AR 03/2013 ; 1112CRA 03/2013; 1812AR 03/2013; 1212CR 

03/2013; 1112CR 03/2013; 2005HA 03/2013; 2053DA 03/2013 


Recalling Firm: Pfizer Inc., New York, NY, by letter on March 16, 2012. 

30

Manufacturer: Catalent Argentina S.A.I.C., Villa Loma Hermosa, Argentina. Firm initiated recall 

is ongoing. 

REASON 

CGMP deviation; enzymatic hydrolysis time for the gelatin manufacturing process of these lots 

was increased which may have caused a stronger odor of the product. 


Levonorgestrel and Ethinyl Estradiol Tablets USP (0.1 mg/0.02 mg) and Ethinyl Estradiol 

Tablets USP (0.01 mg), Rx Only, 2 X 28 Tablets and 1 X 35 Tablets per Pouch, NDC 68180- 

848-11 (pouch), 68180-848-13 (carton). Recall # D-1338-2012 

CODE 

Lot #: 118901386, Exp. 9/2013 


Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letters on March 30, 2012 with a 

follow-up telephone call. 

Manufacturer: Lupin Pharmacare Ltd., Indore Madhya Pradesh, India. Firm initiated recall is 

ongoing. 

REASON 

Impurity/Degradation Products: This product is being recalled due to an out of specification test 

result for an individual unspecified impurity, identified as Bisphenol-A, during the 3 month long 

term stability testing. 


Omnaris (ciclesonide) Nasal Spray 50 mcg, 7.1 g bottle, 60 metered actuations, Professional 

Sample, Rx only, NDC 63402-701-02, UPC 3 63402-702-02 0. Recall # D-1343-2012 

CODE 

Lot # 138122, Exp 08/12 


Recalling Firm: Sunovion Pharmaceuticals Inc., Marlborough, MA, by letter dated May 3, 2012. 

Manufacturer: Nycomed GmbH (frmly: Altana), Singen (hohentwiel), Germany. Firm initiated 

recall is ongoing. 

REASON 

Product Lacks Stability: Pinhole defects in the pouch surrounding the immediate container 

permit air ingress and results in a decrease of the preservative potassium sorbate and an increase 

in an associated impurity. 


Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM-197 Protein) --- Prevnar 13 --- 

One Dose (0.5 mL) FOR IM USE ONLY --- Wyeth Pharm, Inc. US Govt License No. 3 --- NDC 

0005-1971-01. Recall # B-1348-12 

CODE 

Lot: F73652 


Recalling Firm: Pfizer Inc., New York, NY, by letter on February 10, 2012. 

Manufacturer: Pfizer Inc., Pearl River, NY. Firm initiated recall is ongoing. 

REASON 

Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine 0.5mL, formulated and filled with an 

expired serotype 3 conjugate material, was distributed. 

31

Current Drug Shortages 

Rifampin for Injection 


Products Affected - Description 

Rifampin for injection, Bedford 

600 mg lyophilized vial (NDC 55390-0123-01) 

Reason for the Shortage 

• Akorn has sold rifampin to Pfizer who took over the product as of May 1, 2011. 

• Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a 

temporary basis. Product will become available in stages as production resumes. 

• Bedford Laboratories has temporarily suspended the distribution of Ben Venue Laboratories 

manufactured products. Availability of products is updated on the Bedford Laboratories website. 

Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=350 

Source website: www.ashp.org 

Potassium Phosphate Injection 



Potassium phosphate injection, American Regent 

3 mMol/mL, 5 mL vial (NDC 00517-2305-25) 


Potassium phosphate injection, Hospira 




• Hospira was discontinuing their potassium phosphate injections but will be returning to 

market with the 5 mL and 15 mL sizes to help meet demand. 

• American Regent had temporarily suspended manufacture of most drug products 

including all potassium phosphate presentations in April, 2011. 

• American Regent resumed manufacturing in Shirley, New York in early-May, 2011. 

• American Regent has issued a statement that all lots of potassium phosphate may contain 

glass particles and filters must be used. Do not use if there are visible glass particles and 

filter all other product. 



Methazolamide Tablets 



Methazolamide Tablets, Fera 

25 mg tablets, 100 count (NDC 48102-0100-01) 


Methazolamide Tablets, Sandoz 




32

• Fera cannot provide a reason for the shortage. 

• Sandoz cannot provide a reason for the shortage. 



Diazepam Injection 



Diazepam injection 5 mg/mL, Hospira 

2 mL iSecure syringes, package of 10 (NDC 00409-1273-05) 

10 mL vials, package of 10 (NDC 00409-3213-12) 


• Hospira has diazepam on back order due to manufacturing delays. 

• Hospira is the sole supplier of diazepam injection. 



Cyclosporine Injection 



Cyclosporine 50 mg/mL solution for injection, Bedford 

5 mL vial, 10 count (NDC 55390-0122-10) 

Cyclosporine 50 mg/mL solution for injection, Perrigo 

5 mL ampule, 10 count (NDC 00574-0866-10) 

5 mL ampule, 10 count (NDC 00574-0866-10) - discontinued 


• Perrigo acquired Paddock Laboratories in July 2011. Perrigo discontinued cyclosporine 

injection in late-November, 2011. 

• Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 

2011 on a temporary basis. Product will become available in stages as production 

resumes. 

• Bedford Laboratories has temporarily suspended the distribution of Ben Venue 

Laboratories manufactured products. Availability of products is updated on the Bedford 

Laboratories website. 



Terbutaline Sulfate Injection 



Terbutaline sulfate injection, 1 mg/mL, Akorn 

1 mL ampule (NDC 17478-0933-01) 

Terbutaline sulfate injection, 1 mg/mL, Bedford 

1 mL vial, package of 10 (NDC 55390-0101-10) 

1 mL Novaplus vial, package of 10 (NDC 55390-0193-10) 



33


resumes. 




• Akorn cannot provide a reason for the shortage. 



Sterile Empty Vials 



Sterile Empty Vials, Hospira 

30 mL, 50 count (List #05816-31) 

Empty Sterilized Vials, APP 

5 mL, 25 count (NDC 63323-0001-05) 

10 mL, 25 count (NDC 63323-0001-10) 

30 mL, 25 count (NDC 63323-0001-30) 

100 mL, 40 count (NDC 63323-0001-00) 


• Hospira states the shortage is due to manufacturing delays. 

• APP reduced production of sterile empty vials to permit increased production of drug 

products affected by critical shortages. 

• Sterile empty vials may be available from medical supply distributors. 



Labetalol Injection 



Labetalol injection 5 mg/mL, Bedford 

20 mL vials (NDC 55390-0130-20) 

40 mL vials (NDC 55390-0130-40) 

Labetalol injection 5 mg/mL, Hospira 

4 mL Carpuject syringe (NDC 00409-2339-34) 

Labetalol injection 5 mg/mL, Sagent 

20 mL vials (NDC 25021-0300-20) 

40 mL vials (NDC 25021-0300-40) 



2011 on a temporary basis for maintenance and requalification of equipment. Product 

will become available in stages as production resumes. 

• Bedford Laboratories has multiple products affected by this temporary suspension of 

manufacturing. Bedford will have the affected, as well as the available products, listed on 

their website and are updating this information as it changes. 

• Hospira has labetalol on shortage due to manufacturing delays. 

• Sagent could not provide a reason for the shortage. 

34

• Akorn states the reason for the shortage was demand exceeding supply. 

• Apotex discontinued their 4 mL vials (NDC 60505-0717-00) in February, 2010. The 

company could not provide a reason for the discontinuation. 



Argatroban Injection 



Argatroban injection, Medicines Company 

1 mg/mL, 50 mL vials, 1 count (NDC 42367-0203-07) 


• Medicines Company distributes argatroban supplied by Eagle Pharmaceuticals. Eagle 

Pharmaceuticals has voluntarily recalled all lots of argatroban due to the potential for 

visible particulates. 

• Sandoz had argatroban injection on shortage due to increased demand. 



Lansoprazole (OTC) 



Prevacid 24 Hr OTC capsules, Novartis 

15 mg, 14 count (NDC 00067-6286-14) 

15 mg, 28 count (NDC 00067-6286-28) 

15 mg, 42 count (NDC 00067-6286-42) 


• Novartis states the shortage is due to manufacturing delays. 1 

• Prescription lansoprazole 15 mg and 30 mg capsules are not affected by the shortage. 



Hepatitis A Virus Vaccine Inactivated 



Inactivated hepatitis A vaccine, 50 unit/mL, Merck (Vaqta) 

Adult formulation 1 mL single-dose vials, packages of 10 (NDC 00006-4841-41) 

Adult formulation 1 mL single-dose vial, package of 1 (NDC 00006-4841-00) 

Adult formulation 1 mL single-dose prefilled syringe, package of 1 (NDC 00006-4096-31) - 

discontinued 


discontinued 


discontinued 

Pediatric formulation 0.5 mL single-dose prefilled syringes, package of 6 (NDC 00006-4095-09) 

- discontinued 

Inactivated hepatitis A vaccine, 1440 unit/mL, GlaxoSmithKline (Havrix) 

35

Adult formulation, prefilled syringes, packages of 5 (NDC 58160-0826-48) - discontinued 

Pediatric formulation 0.5 mL single-dose prefilled syringe, package of 5 (NDC 58160-0825-46) - 

discontinued 


• Merck was waiting for regulatory approval of a manufacturing change. 

• Merck discontinued all adult and pediatric formulation prefilled syringe presentations. 

• GlaxoSmithKline could not provide a reason for the shortage. 



Azathioprine Injection 



Azathioprine injection, lyophilized powder, Bedford 

100 mg vial (NDC 55390-0600-20) 




resumes. 




• There are no other manufacturers of azathioprine injection. 

• The oral presentations are not affected by this shortage. 



Promethazine Injection 



Promethazine injection, West-Ward 

25 mg/mL 1 mL ampule (NDC 00641-1495-35) 


50 mg/mL 1 mL vial (NDC 00641-0929-25) 

50 mg/mL 1 mL Novaplus vial (NDC 00641-0956-25) 


25 mg/mL 1 mL Novaplus ampule (NDC 00641-0948-35) 

50 mg/mL 1 mL Novaplus ampule (NDC 00641-0949-35) 

Phenergan injection, West-Ward 



Promethazine injection, Hospira 

25 mg/mL 1 mL Carpuject syringe (NDC 00409-2312-31) 

25 mg/mL 1 mL iSecure syringe (NDC 00409-2312-02) - discontinued 

Promethazine injection, Teva 



36


• Teva states the shortage is due to manufacturing delays. 

• West-Ward states the shortage is due to manufacturing delays. The company has also 

changed the NDC numbers for products that were formerly Baxter products. 

• Hospira has promethazine products on back order due to supply interruption. Hospira 

discontinued promethazine 25mg/mL 1 mL iSecure syringe in September 2011. 



Etoposide Injection 



Etoposide solution for injection, 20 mg/mL, Bedford 

5 mL vial (NDC 55390-0291-01) 

25 mL vial (NDC 55390-0292-01) 

50 mL vial (NDC 55390-0293-01) 

5 mL Novaplus vial (NDC 55390-0491-01) 




• Teva had etoposide on shortage due to manufacturing delays. 

• APP had etoposide on shortage due to increased demand. 



resumes. 




• Accord could not provide a reason for the shortage. 



Dacarbazine Injection 



Dacarbazine powder for injection, APP 

100 mg vial (NDC 63323-0127-10) 

Dacarbazine powder for injection, Hospira 

100 mg vial (NDC 61703-0327-22) 

Dacarbazine powder for injection, Teva 

200 mg vial, 1 count (NDC 00703-5075-01) 


Dacarbazine powder for injection, Bedford 

200 mg vial (NDC 55390-0090-10) 


• Teva has dacarbazine on back order due to manufacturing delays. 


37


resumes. 




• Hospira has dacarbazine on shortage due to manufacturing delays. 

• APP has dacarbazine on shortage due to increased demand for the product. 



Aztreonam Injection 



Aztreonam injection 


• BMS acquired Azactam from Elan in April, 2010. 

• APP has increased production of aztreonam and is releasing product regularly to help 

• meet increased demand. 



Ampicillin Sulbactam 



Ampicillin Sulbactam powder for injection, Hospira 

1.5 gram vial, 10 count (NDC 00409-2988-01) 

1.5 gram ADD-Vantage vial, 10 count (NDC 00409-2689-01) 

3 gram vial, 10 count (NDC 00409-2998-03) 

3 gram ADD-Vantage vial, 10 count (NDC 00409-2987-03) 

3 gram Novaplus vial, 10 count (NDC 00409-2987-13) 

15 gram bulk vial, 1 count (NDC 00409-2687-15) 

Unasyn powder for injection, Pfizer 

1.5 gram Add-Vantage vial, 10 count (NDC 00049-0031-83) - discontinued 

1.5 gram bottles, 10 count (NDC 00049-0022-83) - discontinued 

3 gram ADD-Vantage vial, 10 count (NDC 00049-0032-83) - discontinued 

3 gram bottle, 10 count (NDC 00049-0023-83) - discontinued 

Ampicillin Sulbactam powder for injection, Sagent 



Ampicillin Sulbactam powder for injection, West-Ward 

1.5 gram vial, 10 count (NDC 10019-0631-01) – NDC discontinued 

3 gram vial, 10 count (NDC 10019-0630-02) – NDC discontinued 

15 gram bulk vial, 1 count (NDC 10019-0632-03) – NDC discontinued 


1.5 gram Novaplus vial, 10 count (NDC 10019-0636-01) 



38

15 gram Novaplus bulk vial, 1 count (NDC 10019-0638-03) 


• Hospira states that ampicillin sulbactam vials are on back order due to raw material 

shortages. 

• Sagent cannot provide a reason for the shortage. 

• Sandoz states the shortage was due to increased demand for the products. 

• Pfizer discontinued Unasyn 3 gram 10 count bottles in late, 2011. Pfizer discontinued all 

Unasyn Add-Vantage vials and bottles in early 2012. 

• West-Ward acquired several Baxter products in early 2011. 



Amphetamine Mixed Salts, Extended-Release Capsules 



Amphetamine mixed salts extended-release capsules, Teva 

30 mg capsules, 100 count (NDC 00555-0789-02) 

Amphetamine mixed salts extended-release capsules, Global Pharmaceuticals 








• Teva cannot provide a reason for the shortage. 

• Global Pharmaceuticals states the shortage is due to increased demand. 



Vinblastine Injection 



Vinblastine lyophilized powder for injection, Bedford 

10 mg vial (NDC 55390-0091-10) 

Vinblastine sulfate injection, APP 

1 mg/mL, 10 mL vial (NDC 63323-0278-10) 



2011. Product will become available in stages as production resumes. 

• Bedford Laboratories has multiple products affected by this suspension of manufacturing. 

Availability of all products, including those not manufactured at Ben Venue, is updated 

as information changes on the Bedford Laboratories website. 

• APP has their product in short supply due to increased demand for the product and a 

manufacturing delay. 



39

Etoposide 

Valsartan Tablets 



Diovan tablets, Novartis 

40 mg, 100 count, unit-dose (NDC 00078-0423-06) 

320 mg, 90 count (NDC 00078-0360-34) 


• Novartis is the sole supplier of valsartan tablets. 

• Novartis could not provide a reason for the shortage. 



Rocuronium Injection 



Rocuronium 10mg/mL injection, APP 



Rocuronium 10 mg/mL injection, Hospira 

5 mL Novaplus vials, package of 10 (NDC 00409-9558-49) 



10 mL Novaplus vials, package of 10 (NDC 00409-9558-50) 

Rocuronium 10 mg/mL injection, Sandoz 



Rocuronium 10 mg/mL injection, Teva 



Zemuron 10 mg/mL, Merck 




• Merck (formerly Schering-Plough) acquired Zemuron from Organon on July 1, 2008. 

The 5 mL vials were on back order at the time the company acquired the product. Some 

generic products have had intermittent supply problems due to increased demand for 

product. 

• Mylan Institutional (formerly Bioniche) acquired multiple products from Generamedix, 

including rocuronium. Mylan Institutional states the reason for the shortage was 

• increased demand. 

• Hospira has rocuronium on shortage due to a raw materials shortage. 

• Teva has rocuronium on shortage due to manufacturing delays. 

• APP and Sagent cite increased demand as the reason for this shortage. 



40

Milrinone Injection 



Milrinone injection, APP 



Milrinone injection, Baxter 

0.2 mg/mL, 200 mL premixed bags (NDC 00338-6011-37) 

Milrinone injection, Bedford 




1 mg/mL, 10 mL Novaplus vial (NDC 55390-0074-10) 





Milrinone injection, Hospira 



Milrinone injection, West-Ward 



1 mg/mL, 10 mL vial (NDC 10019-0070-01) - discontinued 





• APP states the reason for the shortage is increased demand for the product. 

• West-Ward cannot provide a reason for the shortage. 



resumes. 




• Apotex, Bioniche, and Teva discontinued milrinone 1 mg/mL vials. 

• Sanofi-Aventis discontinued Primacor injection. 



Metformin Oral Tablets 



Metformin tablets, Amneal 

500 mg extended release, 90 count (NDC 53746-0178-90) - discontinued 

500 mg, 1000 count (NDC 65162-0175-11) 

41

1000 mg, 100 count (NDC 65162-0177-10) 

1000 mg, 500 count (NDC 65162-0177-50) 

Metformin tablets, Aurobindo 

1000 mg, 500 count (NDC 65862-0010-05) 

Metformin tablets, Glenmark 

1000 mg, 90 count (NDC 68462-0161-90) 

Metformin tablets, Mutual Pharmaceuticals 

500 mg, 100 count (NDC 53489-0467-01) - discontinued 









Metformin tablets, Mylan 

500 mg, 100 count (NDC 00378-0234-01) 







Metformin tablets, Ranbaxy 




Metformin tablets, Sandoz 

850 mg, 12 x 60 package (NDC 00781-5051-61) 

850 mg, 500 count (NDC 00781-5051-05) 

Metformin tablets, Teva 

500 mg, 100 count, unit dose (NDC 00093-1048-93) - discontinued 



Metformin tablets, UDL 

850 mg, 100 count, unit-dose (NDC 51079-0973-20) - discontinued 




Metformin tablets, Watson 




• Apotex had metformin products unavailable due to an FDA import ban. Metformin 

immediate-release tablets are not being currently marketed at this time. 

• Sandoz has metformin products on shortage due to manufacturing delays. 

42

• Ranbaxy has all discontinued metformin oral tablets. 

• Mutual discontinued all metformin products. 

• Mylan has discontinued several metformin presentations. 

• Teva discontinued metformin unit dose presentations in early-August, 2011. 

• UDL discontinued metformin 500 mg 100 unit dose presentation in late-July, 2011. 

• Watson discontinued metformin 850 mg and 1000 mg presentations. 



Mesna Injection 



Mesna 100 mg/mL Injection, Bedford 


Mesna 100 mg/mL Injection, Teva 



• Teva had a shortage of mesna injection due to manufacturing delays. 




resumes. 






Leflunomide Tablets 



All presentations are available. 


• Apotex relaunched leflunomide tablets in August 2011. 

• Teva has had leflunomide tablets on shortage due to unavailability of raw material. 

• Sandoz has had leflunomide tablets on shortage due to increased demand and delay of 

raw material. 



Haloperidol Lactate Injection 



Haloperidol lactate 5 mg/mL injection, Bedford 

1 mL vial (NDC 55390-0147-10) 

10 mL vial (NDC 55390-0147-01) 

Novaplus 1 mL vial (NDC 55390-0447-10) - discontinued 

43

Haloperidol lactate 5 mg/mL injection, Pfizer 

1 mL vial (NDC 00069-0113-02) 

Haloperidol lactate 5 mg/mL injection, Teva 

1 mL vial (NDC 00703-7041-03) - discounted 

10 mL vial (NDC 00703-7045-01) 




resumes. 




• Teva has haloperidol lactate on shortage due to manufacturing delays. 



Fluconazole Injection 



Fluconazole Injection 2 mg/mL, Baxter 

200 mL premixed bag in NaCl (NDC 00338-6045-37) 

Fluconazole Injection, 2 mg/mL, Bedford 

50 mL vials (NDC 55390-0194-01) 

100 mL vials (NDC 55390-0012-01) 

200 mL vials (NDC 55390-0046-01) 

100 mL premixed bag (NDC 55390-0227-01) 


Fluconazole Injection, 2 mg/mL, Hospira 

100 mL PVC flexible bag (NDC 61703-0414-63) – discontinued 

200 mL PVC flexible bag (NDC 61703-0414-64) – discontinued 

Fluconazole Injection, 2 mg/mL, Teva 

100 mL vial (NDC 00703-1019-09) 


200 mL vial (NDC 00703-1010-09) 



• Teva has fluconazole injection on shortage due to manufacturing delays. 



resumes. 




• Pfizer discontinued their last available fluconazole premixed bags in May, 2011. 

• Sagent had fluconazole injection on shortage due to manufacturing delays. 



44

Doxorubicin Liposomal Injection 



Doxil 2 mg/mL, Janssen Products, LP 

2 mg/mL, 10 mL (20 mg) vial (NDC 59676-0960-01) 

2 mg/mL, 25 mL (50 mg) vial (NDC 59676-0960-02) 


• Janssen Products, LP is the sole supplier of doxorubicin liposomal injection and states the 

shortage is due to manufacturing issues. Janssen Products, LP has posted a Dear 

Healthcare Provider letter and other updates with information about the shortage on 

the Doxil website that is updated regularly. This letter may be accessed online. 

• Janssen Products, LP started an enrollment program called DOXIL C.A.R.E.S. (Creating 

Awareness and Reinforcing Education Support) Physician Access Program to allocate 

remaining supplies of Doxil. Janssen is re-opening enrollment as some allocation requests 

have changed, allowing product to be reallocated. This supply is not new and is the same 

supply produced before Ben Venue halted manufacturing. Physicians may submit 

enrollment forms starting at 12:00 noon Eastern Time on May 11. Enrollment is on a 

first- come first-served basis. The letter supplies additional details. 

• Ben Venue, the contracted manufacturer of Doxil, voluntarily suspended all 

manufacturing and distribution in mid-November, 2011 on a temporary basis for 

maintenance and requalification of equipment. Product will become available in stages as 

production resumes. Products made in the North facility of Ben Venue, including Doxil, 

are not expected to be available until late 2012. 

• FDA is allowing temporary importation of Lipodox (doxorubicin hydrochloride liposome 

injection) from Sun Pharma Global FZE. The product is available as 2 mg/mL 10 mL 

(Lipodox) and 25 mL (Lipodox 50) single use vials, which contain the same active 

ingredient and concentration as the US doxorubicin hydrochloride liposome injection 

(Doxil®). Sun Pharma’s Lipodox is manufactured at an FDA inspected facility in India. 

The authorized distributor, Caraco Pharmaceutical Laboratories is working with FDA to 

make product available to wholesalers in the US. Check your wholesaler for product 

availability. Contact the shortage response team for further information at 888-835-2237 

or fax 800-980-2237. Additional information can be found online, as well. 

• FDA has also posted some frequently asked questions regarding Lipodox online. 



Daunorubicin Hydrochloride Injection 



Daunorubicin hydrochloride solution for injection, 5 mg/mL, Bedford 

4 mL single-dose vial (NDC 55390-0108-10) 

4 mL single-dose vial, Novaplus (NDC 55390-0142-10) 

10 mL single-dose vial (NDC 55390-0108-01) 

Daunorubicin hydrochloride lyophilized powder for injection, Bedford 

20 mg single-dose vial, package of 10, Novaplus (NDC 55390-0805-10) 

Cerubidine lyophilized powder for injection, Bedford 

45

20 mg single-dose vial, package of 10 (NDC 55390-0281-10) 




resumes. 




• Teva had daunorubicin on shortage due to manufacturing issues. 



Amphetamine Mixed Salts, Immediate-Release Tablets 



Amphetamine mixed salts immediate-release tablets, Teva 


7.5 mg tablets, 100 count (NDC 00555-0775-02) 


12.5 mg tablets, 100 count (NDC 00555-0776-02) 




Adderall, Teva 





Amphetamine mixed salts immediate-release tablets, Sandoz 



Amphetamine mixed salts immediate-release tablets, CorePharma 






• Teva states the shortage is due to DEA quota restrictions. 

• CorePharma cannot provide a reason for the shortage. 

• Sandoz states the shortage is due to increased demand. 



Midazolam Injections 



Midazolam Injection, APP 

46

1 mg/mL, 2 mL vial, 25 count (NDC 63323-0411-12) 






5 mg/mL, 1 mL fill in 2 mL vial, 25 count (NDC 63323-0412-25) 

Midazolam Injection, Bedford 

1 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0137-02) 




5 mg/mL, 1 mL preservative-free, in 2 mL vial, 10 count (NDC 55390-0138-01) 



Midazolam Injection, Hospira 

1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 00409-2306-62) 

1 mg/mL, 2 mL preservative-free vial (NDC 00409-2305-17) 

1 mg/mL, 2 mL Novaplus preservative-free vial, 100 count (NDC 00409-2305-21) 


1 mg/mL Novaplus 5 mL preservative-free vial (NDC 00409-2305-50) 

1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 00409-2306-12) 

1 mg/mL Novaplus 10 mL vial (NDC 00409-2587-53) 




5 mg/mL, 1 mL preservative-free Luer-Lock syringe, 10 count (NDC 00409-2307-60) 


5 mg/mL, 2 mL preservative-free Novaplus vial (NDC 00409-2308-50) 

5 mg/mL, Novaplus 10 mL vial (NDC 00409-2596-53) 


Midazolam Injection, Sagent 








Midazolam Injection, West-Ward (formerly Baxter products) 

1 mg/mL, 2 mL vial, 10 count (NDC 10019-0028-02) - discontinued 

1 mg/mL, 2 mL dosette vial (NDC 10019-0028-03) - discontinued 

1 mg/mL, 5 mL vial, 10 count (new NDC 00641-6059-10, old NDC 10019-0028-05) 



1 mg/mL, 2 mL latex free vial, 10 count (new NDC 00641-6057-10, old NDC 10019-0028-01) 


47


5 mg/mL 10 mL vial, 10 count (new NDC 00641-6060-10, old NDC 10019-0027-10) 


• West-Ward acquired Baxter’s midazolam injection products in May, 2011. NDC codes 

began changing for these products in early, 2012. 



resumes. 




• Hospira has midazolam on shortage due to manufacturing delays and demand exceeding 

supply due to current market conditions. 

• Hospira discontinued midazolam 5 mg/mL 1 mL iSecure syringes in July 2011. 

• APP has midazolam on shortage due to increased demand. 



Leucovorin Calcium Injection 



Leucovorin Calcium Lyophilized Powder for Injection, Bedford 



100 mg Novaplus vial, 10 count (NDC 55390-0818-10) 





Leucovorin Calcium Solution for Injection, Bedford 



Leucovorin Calcium Lyophilized Powder for Injection, Teva 



Leucovorin Calcium Lyophilized Powder for Injection, APP 






resumes. 




• Teva has leucovorin on shortage due to manufacturing delays. 

• Spectrum has Fusilev (levoleucovorin) readily available. 

48

• APP has leucovorin on shortage due to increase demand. 

• Leucovorin oral tablets are not affected by the shortage. 



Esomeprazole Magnesium Oral Suspension 



Nexium Delayed-Release Oral Suspension, Astra Zeneca 

10 mg, 30 unit dose packets (NDC 00186-4010-01) 




• Astra Zeneca has Nexium oral suspension on shortage due to manufacturing delays. 

• Nexium oral capsules are not affected by the shortage. 



Butorphanol Injection 



Butorphanol injection, Bedford 







Butorphanol injection, Hospira 




Butorphanol injection, West-Ward 

1 mg/mL 1 mL vial (NDC 00143-9864-10) - discontinued 

2 mg/mL 1 mL vial (NDC 00143-9867-10) - discontinued 


• Apotex discontinued butorphanol injection in 2008. 



resumes. 


Laboratories manufactured products. Availability of products is updated on the 

Bedford Laboratories website. 

• Hospira states the shortage is due to increased demand. 

• West-Ward has discontinued butorphanol injection. 

• Sandoz discontinued Stadol injection in 2010. 


49


Ondansetron Injection 



Ondansetron 2 mg/mL vials 

Ondansetron injection, 2 mg/mL, APP 


Ondansetron injection, 2 mg/mL, Bedford 

20 mL vial (NDC 55390-0121-01) 

Ondansetron injection, 2 mg/mL, Hospira 

2 mL iSecure syringe (NDC 00406-1120-12) 

2 mL vials, packages of 25 (NDC 00409-4755-03) 

20 mL vials (NDC 00409-4759-01) 

Ondansetron injection, 2 mg/mL, West-Ward 

2 mL vials, packages of 5 (NDC 00143-9891-05) - discontinued 


20 mL vials (NDC 00143-9890-01) 

Ondansetron injection, 2 mg/mL, West-Ward (formerly Baxter) 

2 mL Novaplus vials, packages of 25 (NDC 00641-6078-25) 

20 mL Novaplus vials (NDC 00641-6079-01) 

Ondansetron injection, 2 mg/mL, Pfizer 


20 mL vials (NDC 00069-1340-02) 

Ondansetron injection, 2 mg/mL, Teva 



Ondansetron injection, 2 mg\mL, Wockhardt 


20 mL vials (NDC 64679-0727-01) 

Ondansetron 32 mg/50 mL premixed bags 

Ondansetron injection, premixed bags, Baxter 

32 mg/50 mL (NDC 00338-1762-41) 

Ondansetron injection, premixed bags, Claris 

32 mg/50 mL (NDC 36000-0014-06) 

Ondansetron injection, premixed bags, Teva 

32 mg/50 mL (NDC 00703-7239-39) 

Ondansetron injection, premixed bags, Hospira 

32 mg/50 mL (NDC 00409-4760-24) 



• Apotex, Sagent and Cura have discontinued their ondansetron injection. 

• APP has ondansetron on shortage due to increased demand for the product. 

• Teva discontinued ondansetron 2 mL vials in 5 count packages. 

• Caraco temporarily discontinued ondansetron injection. 

• Baxter has discontinued their ondansetron injection 1 mL vial. Baxter states the shortage 

of their 2 mL and 20 mL vials was due to increased demand for the product. 

50

• West-Ward acquired Baxter’s ondansetron vials for injection. West-Ward discontinued 

the ondansetron 20 mL vials in October, 2011 and discontinued ondansetron 2 mg/mL 

vials in packages of 5 in Spring, 2012. 

• Bedford discontinued ondansetron 2 mg/mL 2 mL vials in May, 2011 to concentrate on 

the manufacturing of other products. 



resumes. 




• GlaxoSmithKline have discontinued Zofran 2 mL vials. 

• Hospira has ondansetron on shortage due to quality improvement issues. 

• West-Ward has ondansetron on back order due to increased demand. 


• Hospira has ondansetron premixed bags on shortage due to changes in the manufacturing 

process. 

• Claris recalled all lots of their ondansetron premixed bags in mid-2010. 

• Pfizer discontinued their ondansetron premixed bags in January, 2012. 

• Sagent has discontinued their ondansetron premixed bags. 

• Teva has ondansetron premixed bags on shortage due to manufacturing delays. 

• West-Ward has discontinued their ondansetron premixed bags. 



Meperidine Injection 



Demerol hydrochloride injection, Hospira 

50 mg/mL, 30 mL multi-dose vial (NDC 00409-1181-30) 

100 mg/mL, 20 mL multi-dose vial (NDC 00409-1201-20) 


• Hospira has Demerol injection on shortage due to increased demand and manufacturing delays. 



Ketorolac Tromethamine Injection 



Ketorolac Injection, APP 

15 mg/mL 1 mL vial, 25 count (NDC 63323-0161-01) 


30 mg/mL 2 mL vial for intramuscular injection, 25 count (NDC 63323-0162-02) 

Ketorolac Injection, West-Ward (formerly Baxter products) 




51

Ketorolac Injection, Bedford 




30 mg/mL 2 mL vial for intramuscular use, 10 count (NDC 55390-0481-02) 

Ketorolac Injection, Hospira 

15 mg/mL 1 mL Carpuject syringe, 10 count (NDC 00409-2288-31) 


15 mg/mL 1 mL Novaplus vial, 25 count (NDC 00409-3793-49) 

30 mg/mL 1 mL Carpuject syringe, 10 count (NDC 00409-2287-31) 

30 mg/mL 1 mL vials, 25 count (NDC 00409-3795-01) 

30 mg/mL 2 mL iSecure syringe for intramuscular use, 10 count (NDC 00409-2287-22) 

30 mg/mL 2 mL vials for intramuscular use, 10 count (NDC 00409-3796-01) 

30 mg/mL 2 mL vial for intramuscular use, 25 count (NDC 00409-3796-49) 

30 mg/mL 1 mL Novaplus vial, 25 count (NDC 00409-3795-49) 

Ketorolac Injection, Wockhardt 








• American Regent discontinued all ketorolac injection presentations in 2010. 

• APP states the shortage is due to manufacturing delays. 

• Baxter and Wockhardt could not provide a reason for the shortage. 

• Cura filed for bankruptcy in 2010. 

• Hospira has ketorolac on shortage due to manufacturing delays for quality improvement 

activities and increased demand for the product. 



resumes. 






Ethinyl Estradiol 50 mcg and Norethindrone 1 mg Tablets 



Ovcon-50 (ethinyl estradiol/norethindrone) tablets, Warner Chilcott 

50 mcg/1 mg, 3x28 (NDC 00430-0585-45) 

50 mcg/1 mg, 6x28 (NDC 00430-0585-14) - discontinued 


• Warner Chilcott states the shortage is due to manufacturing delays. 

• There are no other manufacturers of ethinyl estradiol 50 mcg/norethindrone 1 mg tablets. 

52

• Ethinyl estradiol/norethindrone combination tablets are available from multiple 

manufacturers in other concentrations. 



Buprenorphine Injection 



Buprenorphine 0.3 mg/mL injection, American Regent 

1 mL vial (NDC 40042-0010-01) – discontinued 

1 mL vial (NDC 00517-0725-05) 

Buprenorphine 0.3 mg/mL injection, Bedford 

1 mL vial (NDC 55390-0100-10) 

Buprenorphine 0.3 mg/mL injection, Hospira 

1 mL Carpuject syringe (NDC 00409-2012-32) 




resumes. 




• American Regent had temporarily suspended distribution of most drug products including 

buprenorphine in April, 2011. 


• Hospira has buprenorphine on shortage due to product modifications. 



Acyclovir Injection 



Acyclovir lyophilized powder for injection, Bedford Laboratories 

500 mg vial (NDC 55390-0612-10) 

1 g vial (NDC 55390-0613-20) 

Acyclovir lyophilized powder for injection, APP 

500 mg vial (NDC 63323-0105-10) 


• APP is states the shortage is due to increased demand due to market shortage. The 

company has acyclovir lyophilized powder on shortage to concentrate on supplying the 

solution for injection. 



resumes. 




53



Sodium Chloride Concentrated Solution for Injection 



Sodium Chloride 23.4% Solution for Injection 

Sodium Chloride 23.4%, Hospira 

100 mL bulk glass container (NDC 00074-1141-02) 

250 mL bulk glass container (NDC 00074-1130-02) 

50 mL vial (NDC 00074-1141-01) - discontinued 

Sodium Chloride 23.4%, APP 

30 mL vials (NDC 63323-0187-30) 

100 mL vials (NDC 63323-0088-61) 

Sodium Chloride 23.4%, American Regent 

30 mL vials (NDC 00517-2930-25) 

100 mL vials (NDC 00517-2900-25) 

Sodium Chloride 14.6% Solution for Injection 

Sodium Chloride 14.6%, APP 

20 mL vials (NDC 63323-0139-20) 

Sodium Chloride 14.6%, Hospira 

250 mL vials (NDC 00409-4219-02) - discontinued 


• American Regent recalled several lots of concentrated sodium chloride 23.4% 30 mL and 

100 mL vials on March 15, 2011. 

• American Regent had temporarily suspended distribution of the majority of their drug 

• products including sodium chloride 23.4% injections in April, 2011. 


• Baxter discontinued their sodium chloride 250 mL presentation in 2008. 

• APP has sodium chloride concentrated solution on shortage due to increased demand. 

• Hospira has sodium chloride 23.4% solution for injection on shortage due to 

manufacturing delays. Hospira discontinued sodium chloride 14.6% solution 250 mL 

vials in February, 2011. 



Potassium Chloride Injection 



Potassium chloride for Injection, APP 

2 mEq/mL, 10 mEq/5 mL vials, package of 25 (NDC 63323-0965-05) 





Potassium chloride for injection, Baxter 

10 mEq/1000 mL in 5% dextrose (NDC 00338-0681-04) - discontinued 

54

Potassium chloride for injection, Hospira 





40 mEq/1000 mL in 5% dextrose and 0.9% sodium chloride (NDC 00409-7109-09) 

20 mEq/1000 mL in 0.45% sodium chloride (NDC 00409-9257-39) 


• APP states the reason for the shortage is increased demand. 

• Hospira states the reason for the shortage is manufacturing delays. 



Phenytoin Injection 



Phenytoin injection, 50 mg/mL, Hospira 


5 mL ampule (NDC 00409-1317-02) 

Phenytoin injection, 50 mg/mL, West-Ward (formerly Baxter products) 

5 mL vial (NDC 00641-2555-45) 


• West-Ward discontinued their phenytoin in early-June, 2011 for business reasons since 

the company took over several Baxter products including phenytoin. 

• Hospira has phenytoin on shortage due to increased demand for the product and 

prioritizing other Carpuject presentations. 



Oxymorphone Hydrochloride 



Immediate-Release Presentations 

Opana, Endo 



Oxymorphone, Qualitest 




• Novartis voluntarily suspended all manufacturing and distribution from its Lincoln, 

Nebraska facility in early-January 2012 due to a potential for mixing of different products 

within a single bottle. Novartis is gradually resuming manufacturing at this facility after 

manufacturing improvements were implemented. 

• Several Endo products that are manufactured at the Lincoln, Nebraska plant, are affected 

by this manufacturing suspension, including oxymorphone, Opana, and Opana ER. 

• Roxane could not provide a reason for this shortage. 

55



Nalbuphine Injection 



Nalbuphine injection, Hospira 

10 mg/mL 1 mL ampules (NDC 00409-1463-01) 

10 mg/mL, 1 mL Novaplus ampule (NDC 00409-1463-49) 

10 mg/mL 10 mL vials (NDC 00409-1464-01) 

20 mg/mL 1 mL ampules (NDC 00409-1465-01) 

20 mg/mL, 1mL Novaplus ampule (NDC 00409-1465-49) 



• Endo discontinued Nubain in 2008. 

• Teva discontinued all nalbuphine injections in July, 2010. 

• Hospira has nalbuphine on shortage due to manufacturing delays. 



Magnesium Sulfate Injection 



Magnesium sulfate injection, American Regent 




Magnesium sulfate injection, APP 




Magnesium sulfate injection, Hospira 

500 mg/mL, 10 mL syringe (NDC 00409-1754-10) 




magnesium sulfate injection in April, 2011. 


• APP has magnesium sulfate injection on shortage due to increased demand for the 

product. 

• Hospira has magnesium sulfate injection on shortage due to manufacturing delays. 



Labetalol Tablets 



56

Labetalol tablets, Sandoz 

100 mg, 100 count (NDC 00185-0010-01) 

100 mg, 500 count (NDC 00185-0010-05) 

200 mg, 500 count (NDC 00185-0117-05) 

300 mg, 100 count (NDC 00185-0118-01) 

300 mg, 500 count (NDC 00185-0118-05) 

Labetalol tablets, UDL 

200 mg, 100 count, unit dose (NDC 51079-0929-20) 

Labetalol tablets, Watson 

100 mg, 100 count (NDC 00591-0605-01) 

100 mg, 500 count (NDC 00591-0605-05) 

200 mg, 100 count (NDC 00591-0606-01) 

200 mg, 500 count (NDC 00591-0606-05) 

300 mg, 100 count (NDC 00591-0607-01) 

Trandate tablets, Prometheus 

100 mg, 100 count (NDC 65483-0391-10) 

200 mg, 100 count (NDC 65483-0392-10) 

300 mg, 100 count (NDC 65483-0393-10) 


• Major, Sandoz, Teva, Prometheus cannot provide a reason for the shortage. 

• Watson has labetalol tablets on back order due to increased demand. 



Cefpodoxime 



Cefpodoxime, Aurobindo 

100 mg tablet, 20 count (NDC 65862-0095-20) 


50 mg/5 mL, 50 mL suspension (NDC 65862-0140-50) 


100 mg/5 mL, 50 mL (NDC 65862-0141-50) 

100 mg/mL, 100 mL suspension (NDC 65862-0141-01) 

Cefpodoxime, Ranbaxy 








Cefpodoxime, Sandoz 



• Ranbaxy has an import ban on all solid medications including cefpodoxime. 

• Aurobindo cannot provide a reason for the shortage. 

57

• Pfizer has discontinued Vantin. 

• Sandoz could not provide a reason for the shortage. 



Sodium Lactate Injection 



Sodium lactate injection 5 mEq/mL, Hospira 

10 mL vials (NDC 00409-6664-02) 

Sodium lactate injection 167 mEq/L, Baxter 

1 L bags (NDC 00338-0129-04) - discontinued 



• Baxter discontinued sodium lactate 167 mEq/L injection in February, 2012. 



Desmopressin Injection 



Desmopressin injection, 4 mcg/mL, Ferring 

10 mL multi-dose vial (NDC 55566-5040-01) 

Desmopressin injection, 4 mcg/mL, Hospira 

1 mL ampule (NDC 00409-2265-01) 

Desmopressin injection, 4 mcg/mL, Teva 

1 mL vial (NDC 00703-5051-03) 



• Ferring cannot provide a reason for the shortage. 

• Teva and Hospira have desmopressin injection on shortage due to manufacturing delays. 



Chorionic Gonadotropin (Human) Injection 



Chorionic gonadotropin (human) injection, APP 

10,000 unit multiple-dose vial (NDC 63323-0025-10) 

Pregnyl, Merck (formerly Schering-Plough) 


Novarel, Ferring 



• APP cannot provide a reason for the shortage. 

• Merck (formerly Schering-Plough) states their product is on allocation to prevent use in 

58

the gray market. 

• Ferring has Novarel on allocation only to fertility clinics to limit use of their product to 

this patient population. 



Ceftazidime Injection 



Ceftazidime vials 

Ceftazidime injection, Pfizer 

500 mg vials (NDC 00069-0013-01) - discontinued 

1 gm vials (NDC 00069-0011-01) - discontinued 



Ceftazidime injection, Sagent 

1 gm vials, packages of 25 (NDC 25021-0127-20) 

2 gm vials, packages of 10 (NDC 25021-0128-50) 

Ceftazidime injection, Sandoz 

2 gm, vials, packages of 10 (NDC 00781-3178-95) 

Ceftazidime injection, West-Ward 

1 gm vials, packages of 25 (NDC 10019-0691-02) - discontinued 

2 gm vials, packages of 10 (NDC 10019-0692-03) - discontinued 

6 gm vials, packages 6 (NDC 10019-0693-04) - discontinued 

Tazicef injection, Hospira 

1 gm ADD-Vantage vials, packages of 25 (NDC 00409-5092-16) 

1 gm Novaplus ADD-Vantage vials, packages of 25 (NDC 00409-5092-52) 

2 gm ADD-Vantage vials, packages of 10 (NDC 00409-5093-11) 

2 gm Novaplus ADD-Vantage vials, packages of 10 (NDC 00409-5093-51) 


• Pfizer discontinued all of its ceftazidime injection products in late-November, 2011. 

• West-Ward discontinued all of its ceftazidime injection products in January 2012. 

• Hospira has ceftazidime on shortage due to manufacturing delays. 

• Sagent and Sandoz were not able to provide a reason for the shortage. 

• Covis purchased all rights to Fortaz from GlaxoSmithKline. 



Vasopressin Injection 



Vasopressin 20 units/mL Injection, American Regent 

0.5 mL multi-dose vial, 25 count (NDC 00517-0510-25) 

1 mL multi-dose vial, 25 count (NDC 00517-1020-25) 

10 mL multi-dose vial, 10 count (NDC 00517-0410-10) 

Vasopressin 20 units/mL Injection, APP 

1 mL vial (NDC 63323-0302-01) 

59

Pitressin 20 units/mL Injection, JHP 

1 mL single-dose vial, 25 count (NDC 42023-0117-25) 



including vasopressin injection in April, 2011. 1 

• American Regent resumed manufacturing in Shirley, New York in early-May, 2011. 2 

• American Regent recalled 17 lots of vasopressin in August, 2011 due to potential for 

decreased potency. 

• JHP has Pitressin on shortage due to increased demand for the product. 3 



Methylphenidate Hydrochloride 


Products Affected – Description 

Extended-Release Presentations 

Methylphenidate Sustained-Release, Sandoz 


Methylphenidate ER, Watson 





Methylin ER, Mallinckrodt 



Immediate Release Presentations 

Methylin, Mallinckrodt 


5 mg tablets, 1000 count (DC 00406-1121-10) 





Methylphenidate, Sandoz 


Methylphenidate, Watson 





• Novartis and UCB cannot provide a reason for the shortage. 

• Mallinckrodt states the shortage is due to delay in the release of their DEA quota. 

• Sandoz states that the shortage is due to delay in obtaining raw materials. 

• JOM could not provide a reason for the shortage. 

• Watson states the shortage is due to increased demand for their products. 


60


Lorazepam injectable presentations 



Lorazepam 2 mg/mL, Akorn 

1 mL vial (NDC 17478-0040-01) 

Lorazepam 2 mg/mL, Bedford 



Lorazepam 4 mg/mL, Bedford 



Lorazepam 2 mg/mL, Hospira 

1 mL iSecure prefilled syringes (NDC 00409-1985-05) - discontinued 

1 mL Carpuject syringes (NDC 00409-1985-30) 

1 mL vial (NDC 00409-6778-02) 

10 mL vials (NDC 00409-6780-02) 

Lorazepam 4 mg/mL, Hospira 

1 mL vial (NDC 00409-6779-02) 

10 mL vial (NDC 00409-6781-02) 

1 mL Carpuject syringes (NDC 00409-1539-31) 

Lorazepam 2 mg/mL, West-Ward 

1 mL vial (NDC 00641-6044-25) 

10 mL vial (NDC 00641-6046-10) 





1 mL Novaplus vial (NDC 10019-0105-01) - discontinued 


Ativan 2 mg/mL, West-Ward 

1 mL vial (NDC 00641-6001-25) 

10 mL vial (NDC 00641-6000-10) 



Lorazepam 4 mg/mL, West-Ward 

1 mL vial (NDC 00641-6045-25) 


10 mL vial (NDC 00641-6047-10) 






Ativan 4 mg/mL, West-Ward 

1 mL vial (NDC 00641-6003-25) 

61

10 mL vial (NDC 00641-6002-10) 




• Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of 

other products. 

• West-Ward acquired Baxter’s lorazepam injection products in May, 2011. NDC numbers 

for the lorazepam and Ativan products were changed in April, 2012. The company cannot 

provide a reason for the shortage. 

• Hospira states lorazepam vials are on shortage due to increased demand. The 1 mL 

iSecure syringes were discontinued in September 2011. 

• Akorn has increased production to help meet demand. 



Hydromorphone Hydrochloride Injection 



Hydromorphone Injection, Hospira 

1 mg/mL, 1 mL Carpuject syringes (NDC 00409-1283-31) 

1 mg/mL, 1 mL iSecure syringes (NDC 00409-1283-10) 

1 mg/mL, 1 mL ampules (NDC 00409-2552-01) 


2 mg/mL, 1 mL iSecure syringes (NDC 00409-1312-10) 


2 mg/mL, 1 mL vials (NDC 00409-3365-01) 




Hydromorphone Injection, West-Ward 


2 mg/mL, 20 mL multi-dose vials (NDC 00641-2341-41) 

Dilaudid injection, Purdue 

1 mg/mL, 1 mL ampules, package of 10 (NDC 59011-0441-10) 





• Hospira has hydromorphone injection on shortage due to manufacturing delays. 

• West-Ward could not provide a reason for the shortage. 

• Purdue could not provide a reason for the shortage. 



Fentanyl Injection 



62

Fentanyl Injection 50 mcg/mL, Hospira 

10 mL ampules (NDC 00409-9093-36) - discontinued 


2 mL ampule (NDC 00409-9093-32) 

5 mL ampule (NDC 00409-9093-35) 

20 mL ampule (NDC 00409-9093-38) 

2 mL vial (NDC 00409-9094-22) 

5 mL vial (NDC 00409-9094-25) 

10 mL vial (NDC 00409-9094-28) 

20 mL vial (NDC 00409-9094-31) 

50 mL vial (NDC 00409-9094-61) 

Fentanyl Injection 50 mcg/mL, West-Ward (formerly Baxter products) 

10 mL ampule (NDC 10019-0034-73) - discontinued 

30 mL single-dose vial (NDC 10019-0036-82) - discontinued 

20 mL ampule (NDC 10019-0035-74) 

2 mL vial (NDC 10019-0037-27) 

50 mL vial (NDC 10019-0037-83) 

5 mL ampule (NDC 10019-0033-72) 

5 mL vial (NDC 10019-0037-30) 

20 mL vial (NDC 10019-0037-25) 


• West-Ward acquired Baxter’s fentanyl injection products in May, 2011. The company 

cannot provide a reason for the shortage. 

• Hospira states the shortage is due to increased demand and manufacturing delays 

including quality improvement activities. Hospira is increasing production of the 

ampules to help meet the demand. 

• Akorn launched Sublimaze injection in late-March, 2012. 



Droperidol Injection 



Droperidol injection, 2.5 mg/mL, Hospira 

2 mL ampule (NDC 00409-1187-01) 



droperidol injection in April, 2011. 


• Hospira has droperidol on shortage due to increased demand for the product. 



Dantrolene Oral 



Dantrolene capsules, Global Pharmaceuticals 

63

25 mg, 100 count (NDC 00115-4411-01) 

Dantrium capsules, JHP Pharmaceuticals 

25 mg, 100 count (NDC 42023-0124-01) 

50 mg, 100 count (NDC 42023-0125-01) 


• JHP Pharmaceuticals states the reason for the shortage is due to increased demand. 

• Global Pharmaceuticals could not provide a reason for the shortage. 



Bupivacaine with epinephrine injection 



Bupivacaine 0.25% with epinephrine 

Bupivacaine 0.25% with epinephrine 1:200,000 injection, Hospira 

10 mL vial, preservative-free (NDC 00409-9042-01) 

50 mL vial, multi-dose (NDC 00409-9043-01) 

Marcaine 0.25% (with epinephrine 1:200,000) injection, Hospira 



Sensorcaine 0.25% (with epinephrine 1:200,000), APP 





Bupivacaine 0.5% with epinephrine 1:200,000 injection, Hospira 



Marcaine 0.5% with epinephrine 1:200,000 injection, Hospira 



Sensorcaine 0.5% with epinephrine 1:200,000, APP 



30 mL vial, preservative-free, sterile pack (NDC 63323-0462-31) 



Sensorcaine 0.75% with epinephrine 1:200,000, APP 



• APP has Sensorcaine with epinephrine on shortage due to increased demand for the 

product. 

• Hospira has bupivacaine with epinephrine and Marcaine with epinephrine on shortage 

due to manufacturing delays. 



64

Bupivacaine Injection 



Bupivacaine 0.25% 

Bupivacaine 0.25% injection, Hospira 




30 mL glass ampule (NDC 00409-1158-01) 

20 mL glass ampule, sterile pack (NDC 00409-4272-01) 

Marcaine 0.25% injection, Hospira 




Sensorcaine 0.25%, APP 






Bupivacaine 0.5%, Hospira 






20 mL glass ampule, sterile pack (NDC 00409-4273-01) 

Marcaine 0.5%, Hospira 










Bupivacaine 0.75%, Hospira 



Marcaine 0.75%, Hospira 







65

• APP has Sensorcaine on shortage due to increased demand for the product. 

• Hospira has bupivacaine and Marcaine on shortage due to manufacturing delays. 



Triamterene and Hydrochlorothiazide Capsules and Tablets 



Triamterene and Hydrochlorothiazide capsules, Sandoz 

50 mg/25 mg, 100 count (NDC 00781-2715-01) 

Triamterene and Hydrochlorothiazide tablets, Sandoz 

37.5 mg/25 mg, 500 count (NDC 00781-1123-05) 

Triamterene and Hydrochlorothiazide tablets, Mylan 

37.5 mg/25 mg, 100 count (NDC 00378-1352-01) 

37.5 mg/25 mg, 500 count (NDC 00378-1352-05) 

75 mg/50 mg, 100 count (NDC 00378-1355-01) 

75 mg/50 mg, 500 count (NDC 00378-1355-05) 

Maxzide tablets, Mylan 

75 mg/50 mg, 100 count (NDC 00378-0460-01) 


• Watson could not provide a reason for the shortage. 

• Sandoz states the shortage is due to a raw material shortage and capacity issues. 



Sulfamethoxazole/Trimethoprim Injection 



Sulfamethoxazole 80 mg/trimethoprim 16 mg/mL injection, Teva 

5 mL vial (NDC 00703-9503-03) 

10 mL vial (NDC 00703-9514-03) 

30 mL vial (NDC 00703-9526-01) 


• Sulfamethoxazole/trimethoprim injection is on back order due to manufacturing problems 

and a recall. 1,2 

• Teva is the sole supplier of sulfamethoxazole/trimethoprim injection. 3 



Ropivacaine Injection 



Naropin Injection, 5 mg/mL, APP 

30 mL sterile pack single dose vial (NDC 63323-0286-31) 


• APP states the reason for the shortage is due to increased demand due to shortage in other 

anesthetic drugs. 

66



Prochlorperazine Edisylate Injection 



Prochlorperazine injection 5 mg/mL, Bedford 


10 mL vial (NDC 55390-0077-01) 







• Bedford is the sole manufacturer of prochlorperazine injection. 



Nitazoxanide Oral Presentations 



Alinia, Romark Laboratories 

500 mg tablets, 30 count bottles (NDC 67546-0111-12) 

500 mg tablets, 60 count bottles (NDC 67546-0111-11) 

100 mg/5 mL powder for suspension, 60 mL bottle (NDC 67546-0212-21) 


• Romark states the reason for the shortage is manufacturing delay. 



Methocarbamol Injection 



Robaxin, West-Ward 

100 mg/mL, 10 mL vials, package of 25 (NDC 60977-0150-01) 


• West-Ward cannot provide a reason for the Robaxin shortage. 

• There are no other manufacturers of methocarbamol injection. 



Mannitol Injection 



Mannitol injection, American Regent 


67

Mannitol injection, APP 


Mannitol injection, Hospira 


200 mg/mL, 250 mL premixed bag (NDC 00409-7715-02) 



• Hospira has mannitol injection on shortage due to manufacturing delays. 

• APP has mannitol injection on shortage due to increased demand for the product. 

• BBraun had mannitol injection on shortage due to increased demand for the product. 

• American Regent had temporarily suspended manufacture of most drug products in April, 

2011. 




Liotrix Tablets 



Thyrolar tablets, Forest Laboratories 

12.5/3.1, 100 count (NDC 00456-0040-01) 

25/6.25, 100 count (NDC 00456-0045-01) 

50/12.5, 100 count (NDC 00456-0050-01) 

100/25, 100 count (NDC 00456-0055-01) 

150/37.5, 100 count (NDC 00456-0060-01) 


• Thyrolar tablets from Forest Laboratories are on back order due to manufacturing changes. 



Levothyroxine Sodium Injection 



Levothyroxine sodium lyophilized powder for injection, APP 

100 mcg vial (NDC 63323-0649-07) 

500 mcg vial (NDC 63323-0648-10) 

Levothyroxine sodium lyophilized powder for injection, APP 

200 mcg vial (NDC 63323-0247-10) - discontinued 

500 mcg vial (NDC 63323-0248-10) - discontinued 


• APP received FDA approval in July, 2011 for new product and have discontinued old 

grandfathered product that was not FDA approved. The new products are 100 mcg and 

500 mcg strengths instead of 200 mcg and 500 mcg strengths. 

• APP has levothyroxine injection on shortage due to short-term manufacturing delays. 



68

Heparin Sodium Injection 



Heparin Sodium for Injection 

Heparin sodium injection, APP 

1,000 unit/mL, 10 mL multiple-dose vial (NDC 63323-0540-11) 

10,000 unit/mL, 0.5 mL single-dose vial (NDC 63323-0543-02) 

5,000 unit/mL, 10 mL multiple-dose vial (NDC 63323-0047-10) 

Heparin sodium injection, West-Ward 

1,000 unit/mL, 2 mL vial (NDC 00641-0391-12) 





Heparin sodium injection, Hospira 14 

10,000 unit/mL, 0.5 mL Carpuject, package of 50 (NDC 00409-1316-32) 

Heparin sodium injection, Sagent 



Heparin Sodium Flush Solution 

Heparin sodium flush for injection, APP 

10 unit/mL, 1 mL preservative-free vial (NDC 63323-0557-01) 

100 units/mL, 1 mL preservative-free vial (NDC 63323-0549-01) 

Heparin sodium flush solution for injection, Hospira 

10 unit/mL, 10 mL multiple-dose vial (NDC 00409-1151-70) 

10 unit/mL, 1 mL Luer-lock syringe, (NDC 00409-1280-31) 

10 unit/ mL, 2 mL, Luer lock syringe (NDC 00409-1280-32) 

10 unit/mL, 3 mL Luer lock syringe (NDC 00409-1280-33) 



100 unit/mL. 2 mL Carpuject syringes (NDC 00409-1281-32) 

100 unit/mL. 5 mL Carpuject syringes (NDC 00409-1281-35) 

Heparin sodium large volume infusion solutions 

Heparin sodium large volume infusion solutions, Hospira 

12,500 unit/250 mL in Dextrose 5% injection (NDC 00409-7794-62) 

12,500 unit/250 mL in 0.45% Sodium Chloride injection (NDC 00409-7651-62) 

20,000 unit/250 mL in Dextrose 5% injection (NDC 00409-7760-03) 



25,000 unit/ 250 mL in Dextrose 5% injection (NDC 00409-7793-62) 

25,000 unit/ 500 mL in Dextrose 5% injection (NDC 00409-7761-03) 

Heparin sodium large volume infusion solutions, Baxter 



• Baxter has recalled all single-dose and multiple-dose vials of heparin sodium 1,000 

unit/mL, 5,000 unit/mL and 10,000 unit/mL concentrations, as well as all heparin lock 

flush products (i.e., 10 unit/mL and 100 unit/mL). In early 2008, Baxter recalled nine lots 

69

of the 1,000 unit/mL concentration and temporarily stopped manufacturing all multipledose 

vials of its 1,000 unit/mL, 5,000 unit/mL, and 10,000 unit/mL heparin sodium 

injection, due to recent reports of severe allergic reactions in patients receiving bolus 

doses of these products. However, the warning was broadened to include all heparin vial 

products in all concentrations, as these are obtained from the same source manufacturer. 

Baxter has stopped manufacturing and shipping these products in order to investigate the 

cause of these adverse events. In late November, 2009 Baxter announced that all large 

volume heparin sodium in Dextrose 5% premix solutions will become unavailable for an 

extended time period. The company is working to implement new manufacturing 

procedures associated with the new USP reference standard for heparin products. Large 

volume heparin sodium in 0.9% sodium chloride is available. 

• FDA has issued import bans against 22 Chinese manufacturers of heparin due to 

inadequate good manufacturing practices (GMPs). 

• West-Ward obtained five presentations of the heparin sodium injection from Baxter in 

September, 2011. Baxter only retained two large volume heparin presentations. All other 

Baxter presentations have been discontinued. 

• APP was allocating supplies of its heparin sodium in response to the Baxter action. APP 

reports that heparin-lock products are on back order due to increased demand for the 

product. 

• Hospira states the shortage of heparin vials is due to supply and demand issues. In 

January, 2010 Hospira announced that all large volume heparin sodium in Dextrose 5% 

premix solutions and one presentation of heparin sodium in 0.45% sodium chloride 

(NDC 00409-7650-62) will be unavailable through the end of March, 2010. The company 

is working to implement new manufacturing procedures associated with the new USP 

reference standard for heparin products. The company states the large volume solutions 

formulated in either Dextrose 5% or 0.45% Sodium Chloride are specifically affected 

because of the impact pH differences have on the new testing. 

• B. Braun recalled 23 lots of their heparin sodium large volume infusion solutions as a 

precautionary measure after their supplier found a heparin-like contaminant in one lot of 

raw material. Product subject to the recall was distributed in both the US and Canada, 

including: 

o Heparin sodium 1,000 unit/500 mL in 0.9% Sodium Chloride injection (NDC 

00264-9872-10): Lot numbers J7C477, J7C557, J7C611, J7C705, J7D485, 

o 

J7E415, J7E416, J7E589, J7N519, and J7N676. 

Heparin sodium 20,000 unit/500 mL in Dextrose 5% injection (no NDC number, 

not distributed in US): Lot number J7D580 

o Heparin sodium 25,000 unit/250 mL in Dextrose 5% injection (NDC 00264-9587- 

20): Lot numbers J7C470, J7D490, J7E420 (not distributed in US), J7E494, 

J7N556, and J7P476. 

o Heparin sodium 25,000 unit/500 mL in Dextrose 5% injection (NDC 00264-9577- 

10): Lot numbers J7C684, J7D496, J7E500, J7E577 (not distributed in US), 

J7N604, and J7P404. 

• Covidien recalled 32 lots of prefilled heparin lock syringes after their supplier found a 

heparin-like contaminant in two lots of raw material. The affected lots include: 

o Heparin sodium 10 unit/mL, 2.5 mL lock flush syringe, NDC 17474-0123-02 (Lot 

7051444) 

o 

Heparin sodium 10 unit/mL, 3 mL lock flush syringe, NDC 17474-0123-03 (Lots 

7051524, 7113214) 

70

o Heparin sodium 10 unit/mL, 5 mL lock flush syringe, NDC 17474-0123-05 (Lots 

7051524, 7082274, 7113164, 7113174) 

o Heparin sodium 10 unit/mL, 5 mL lock flush syringe with Bluntip cannula, NDC 

08881-1571-25 (Lot 7082274) 

o Heparin sodium 10 unit/mL, 10 mL lock flush syringe, NDC 17474-0123-01 (Lot 

7082274, 7113214) 

o Heparin sodium 100 unit/mL 3 mL lock flush syringe, NDC 17474-0125-03 (Lots 

7041194, 7072154, 7113034, 8010194) 

o Heparin sodium 100 unit/mL 5 mL lock flush syringe, NDC 17474-0125-05 (Lots 

7041194, 7041204, 7051534, 7051544, 7051554, 7071924, 7072034, 7072044, 

7072054, 7072064, 7072154, 7082284, 7102804, 7113034, 7113044, 7113054, 

7113104, 7113114, 7113154, 8010064, 8010114, 8010134, 8010174) 

o Heparin sodium 100 unit/mL 5 mL lock flush syringe with Bluntip cannula, NDC 

08881-5911-25 (Lot 7082284) 

o Heparin sodium 100 unit/mL 10 mL lock flush syringe, NDC 17474-0125-01 (Lot 

7113064) 

• Sagent has heparin on shortage due to manufacturing delays. 



Epinephrine Injection 



Epinephrine injection, American Regent 

1 mg/mL, 1 mL ampule, sulfite-free, package of 25 (NDC 00517-1071-25) 

1 mg/mL, 30 mL multi-dose vial, package of 5 (NDC 00517-1130-05) 

Epinephrine injection, Amphastar 

0.1 mg/mL, 10 mL syringe, package of 10 (NDC 00548-3316-00) 

Epinephrine injection, Hospira 

0.1 mg/mL, 10 mL Lifeshield 18 gauge glass syringe, package of 10 (NDC 00409-4901-18) 

0.1 mg/mL, 10 mL Lifeshield 21 gauge glass syringe, package of 10 (NDC 00409-4921-34) 



2011. 


• Hospira has epinephrine syringes on shortage due to manufacturing delays. 



Dipyridamole Injection 



Dipyridamole 5 mg/mL injection, Teva 





71


• Bedford discontinued dipyridamole injection in May, 2011 to concentrate on the 

manufacturing of other products. 

• Teva has temporarily discontinued their 2 mL and 10 mL products in order to increase 

the package sizes. 



Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP) 



Daptacel Vaccine, Sanofi Pasteur 

0.5 mL single dose vial, package of 1 (NDC 49281-0286-01) 




• Sanofi Pasteur states the reason for the Daptacel shortage is manufacturing delay, which 

will reduce supplies below current demand. 1,2 

• Sanofi Pasteur discontinued Tripedia in 2011. 



Diphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and 

Haemophilus B Conjugate Vaccine (DTaP - IPV/Hib) 



Pentacel Vaccine, Sanofi Pasteur 



• Sanofi Pasteur states the reason for the shortage is manufacturing delay, which will 

reduce supplies below current demand. 



Diphenhydramine Hydrochloride for Injection 



Diphenhydramine injection, 50 mg/mL, Hospira 


Diphenhydramine injection, 50 mg/mL, Mylan Institutional 

10 mL vial (NDC 67457-0124-10) 


• Mylan Institutional cannot provide a reason for the shortage of diphenhydramine. 

• Hospira discontinued diphenhydramine iSecure syringes in 2011. 

• West-Ward could not provide a reason for the shortage. 

• Pfizer discontinued all Benadryl injection in 2005. 

• IMS discontinued diphenhydramine injection in April 2008. 

72



Diltiazem Injection 



Diltiazem Injection, Bedford 




5 mg/mL 5 mL Novaplus vials (NDC 55390-0566-05) 



Diltiazem Injection, Hospira 


5 mg/mL, 10 mL vials, NDC 00409-1171-02) 

Diltiazem Injection, West-Ward 







resumes. 




• Hospira has diltiazem injection on back order due to increased demand for the product. 

• West-Ward could not provide a reason for the shortage. West-Ward changed NDC 

numbers in 1 st quarter, 2012. 

• Teva discontinued all diltiazem presentations in March, 2011. 

• Biovail discontinued Cardizem Lyo-Ject in 2007 due to business reasons. 

• Akorn launched diltiazem 5 mL and 10 mL vials in early-April, 2012. 



Cyanocobalamin Injection 



Cyanocobalamin injection, American Regent 

1000 mcg/mL, 1 mL vial (NDC 00517-0031-25) 



including cyanocobalamin injection in April, 2011. 


• APP has cyanocobalamin injection on shortage due to increased demand for the product. 


73


Carboplatin Solution for Injection 



Carboplatin lyophilized powder for injection, APP 

150 mg vial (NDC 63323-0167-21) 

Carboplatin solution for injection, 10 mg/mL, APP 


Carboplatin solution for injection, 10 mg/mL, Hospira 



15 mL Novaplus multi-dose vial (NDC 61703-0360-22) 


45 mL Novaplus multi-dose vial (NDC 61703-0360-50) 


Carboplatin solution for injection, 10 mg/mL, Sandoz 




Carboplatin solution for injection, 10 mg/mL, Teva 




• Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of 


• Teva has carboplatin injection on shortage due to manufacturing delays. 

• APP has carboplatin on shortage due to increased demand for the product. 

• Sandoz has carboplatin on shortage due to manufacturing delays. 



Amiodarone Hydrochloride Injection 



Amiodarone 50 mg/mL injection, APP 


Amiodarone 50 mg/mL injection, Hospira 

3 mL ampules, package of 10 (NDC 00409-4348-35) 

3 mL Novaplus ampules, package of 10 (NDC 00409-4348-49) 

Amiodarone 50 mg/mL injection, Mylan Institutional 



Amiodarone 50 mg/mL injection, Sagent 

3 mL syringes (NDC 25021-0302-73) - discontinued 


74

• Amphastar and Baxter have discontinued amiodarone vials. 

• Teva discontinued amiodarone injection in 2010. 

• Bedford discontinued all amiodarone presentations in May, 2011 to concentrate on the 

manufacturing of other products. 

• GeneraMedix and Apotex discontinued amiodarone injection some time ago. 

• Sagent recalled amiodarone injection in February 2010 and subsequently discontinued 

amiodarone injection in March 2012. 

• Hospira has amiodarone injection on shortage due to manufacturing delays. 

• APP has amiodarone injection on shortage due to increased demand. 

• Mylan institutional could not provide a reason for the shortage. 



Aminophylline Injection 



Aminophylline injection, American Regent 




• American Regent had temporarily suspended distribution of most drug products in April, 

2011. 


• Hospira states that the shortage was due to manufacturing delays. 

• Hospira discontinued aminophylline ampules in September, 2011. 



Acyclovir Capsules and Tablets 



Acyclovir tablets, Major 

400 tablets, 100 count (NDC 00904-6121-61) 

Acyclovir capsules and tablets, Ranbaxy 




200 mg capsules, 500 count (NDC 63304-0652-05) - discontinued 

Acyclovir capsules and tablets, Teva 


200 mg capsules, 100 count, unit dose (NDC 00093-8940-93) 



400 mg tablets, 100 count, unit-dose (NDC 00093-8943-93) 



800 mg tablets, 100 count, unit-dose (NDC 00093-8947-93) 

75


Acyclovir capsules, UDL 

200 mg capsules, 100 count unit dose (NDC 51079-0447-20) - discontinued 


• Apotex had halted manufacturing due to an FDA audit. 

• Ranbaxy has acyclovir capsules and tablets on back order due to a raw materials 

shortage. 

• Teva and Major could not provide a reason for the shortage. 

• UDL discontinued acyclovir capsules in April, 2012. 



Warfarin Sodium Tablets 



Coumadin Tablets, Bristol Myers Squibb (BMS) 

7.5 mg, unit dose, package of 100 (NDC 00056-0173-75) 

10 mg, unit-dose, package of 100 (NDC 00056-0174-75) 

6 mg, 100 count bottles (NDC 00056-0189-70) 





2.5 mg, unit-dose, package of 100 (NDC 00056-0176-75) 


• BMS cannot provide a reason for the shortage. 

• Generic suppliers are not affected by this shortage. 

• Interchanging products between manufacturers is not recommended and could lead to 

altered INR levels. 



Tolmetin Sodium 



Tolmetin sodium, Mylan 



Tolmetin sodium, Teva 



• Mylan could not provide a reason for the shortage. 

• Teva states the reason for the shortage is demand exceeds available supply. 



76

Fludarabine Injection 



Fludarabine solution for injection, Teva 


25 mg/mL, 2 mL Novaplus vial (NDC 00703-4852-91) - discontinued 

Fludarabine lyophilized powder, Teva 

50 mg vial (NDC 00703-5854-01) 

Fludarabine lyophilized powder, APP 

50 mg vial (NDC 63323-0196-06) 

Fludarabine lyophilized powder, Hospira 

50 mg vial (NDC 61703-0344-18) 

Fludarabine lyophilized powder, Sagent 

50 mg vial (NDC 25021-0205-05) 

Fludara lyophilized powder, Genzyme 8 

50 mg vial, NDC 50419-0511-06) 


• APP has fludarabine lyophilized powder for injection on shortage due to focus on 

supplying solution for injection. 

• Teva has fludarabine on shortage due to manufacturing delays. 

• Sagent has fludarabine on shortage due to increased demand for product. 

• Hospira has fludarabine on shortage due to manufacturing delays. 

• Genzyme could not provide a reason for the shortage. 



Doxorubicin Injection 



Doxorubicin solution for injection, 2 mg/mL, Teva 

5 mL vial (NDC 00703-5043-03) 

25 mL vial (NDC 00703-5046-01) 

100 mL vial (NDC 00703-5040-01) 

Adriamycin solution for injection, 2 mg/mL, Bedford 

5 mL vial (NDC 55390-0235-10) 

10 mL vial (NDC 55390-0236-10) 

25 mL vial (NDC 55390-0237-01) 

100 mL vial (NDC 55390-0238-01) 

Doxorubicin solution for injection, 2 mg/mL, Bedford 

Novaplus 5 mL vial (NDC 55390-0245-10) 

Novaplus 10 mL vial (NDC 55390-0246-10) 

Novaplus 25 mL multi-dose vial (NDC 55390-0247-01) 

Novaplus 100 mL multi-dose vial (NDC 55390-0248-01) 

Adriamycin lyophilized powder, Bedford 

10 mg vials (NDC 55390-0231-10) 

20 mg vials (NDC 55390-0232-10) 

50 mg vial (NDC 55390-0233-01) 

77

Doxorubicin lyophilized powder, Bedford 

Novaplus 10 mg vial (NDC 55390-0241-10) 

Novaplus 50 mg vial (NDC 55390-0243-01) 




resumes. 




• Teva has doxorubicin on shortage due to manufacturing issues. 



Cyclosporine (Modified) Oral Presentations 



Cyclosporine (modified) oral products, Sandoz 



Cyclosporine (modified) oral products, Teva 



Cyclosporine (modified) oral products, Watson 



• Sandoz has cyclosporine (modified) capsules on shortage due to manufacturing delays. 

• Teva has cyclosporine (modified) capsules on shortage due to increased demand. 

• Watson cannot provide a reason for the shortage of cyclosporine (modified) capsules. 



Calcium Acetate Capsules 



Calcium acetate capsules, Roxane 


PhosLo capsules, Fresenius 



• Roxane and Fresenius cannot provide a reason for the shortage 



BCG Vaccine Live Intravesical 

May 21, 2012. 


78

TheraCys Intravesical Injection, Sanofi Pasteur 

81 mg lyophilized powder (NDC 49281-0880-03) 

Tice BCG Intravesical Injection, Merck 



• Sanofi Pasteur states the reason for the shortage is manufacturing delay. 

• Merck could not provide a reason for the shortage. 



Valproate Sodium Injection 



Valproate injection, Bedford 








• APP could not provide a reason for the shortage. 



Sodium Acetate Injection 



Sodium acetate, American Regent 

2 mEq/mL, 20 mL vial (NDC 00517-2096-25) 



Sodium acetate, APP 


Sodium acetate, Hospira 






all sodium acetate presentations in April, 2011. 


• APP has sodium acetate on shortage due to increased demand. 

• Hospira has sodium acetate on shortage due to increased demand. 

• Baxter discontinued sodium acetate in June, 2008. 



79

Paclitaxel Injection 



Paclitaxel 6 mg/mL injection, APP 

100 mg/16.7 mL vial (NDC 63323-0763-05) 

300 mg/50 mL vial (NDC 63323-0763-50) 

Paclitaxel 6 mg/mL injection, Bedford 

30 mg/5 mL vial (NDC 55390-0114-05) 

100 mg/16.7 mL vial (NDC 55390-0114-20) 

300 mg/50 mL vial (NDC 55390-0114-50) 

30 mg/5 mL Novaplus vial (NDC 55390-0304-05) 

100 mg/16.7 mL Novaplus vial (NDC 55390-0304-20) 

300 mg/50 mL Novaplus vial (NDC 55390-0304-50) 

Paclitaxel 6 mg/mL injection, Sandoz 

30 mg/5 mL vial (NDC 66578-0043-01) 

100 mg/16.7 mL vial (NDC 66578-0043-02) 

300 mg/50 mL vial (NDC 66578-0043-03) 


• APP has paclitaxel on shortage due to increase demand for the product. 



resumes. 




• Teva had paclitaxel on shortage due to manufacturing delays. 

• Sandoz has paclitaxel on back order due to a raw material shortage. 

• Hospira had paclitaxel on back order due to increased demand for the product. 

• Sagent could not provide a reason for the shortage of paclitaxel. 

• Pfizer launched paclitaxel 100 mg and 300 mg vials in March, 2012 and launched the 30 

mg vials in April, 2012. 



Orphenadrine Citrate Injection 



Orphenadrine citrate injection, 30 mg/mL, Bedford 



• Watson stated the shortage was due to production delays. 








80

Nystatin Oral Suspension 



Nystatin Oral Suspension, 100,000 units/mL, Precision Dose 

5 mL oral syringes, package of 50 (NDC 68094-0599-58) 


• Fougera and Actavis have discontinued nystatin oral suspension. 

• Qualitest states the reason for the shortage is a raw materials shortage. 

• Taro and PAI could not provide a reason for the shortage. 



Norepinephrine Injection 



Norepinephrine, 1 mg/mL, Bedford 

4 mL vial, package of 10 (NDC 55390-0002-10) 

Levophed, 1 mg/mL, Hospira 

4 mL ampules, package of 10 (NDC 00409-1443-04) 


Norepinephrine, 1 mg/mL, Teva 

4 mL vial, package of 10 (NDC 00703-1153-03) - temporarily discontinued 




resumes. 




• Teva temporarily discontinued norepinephrine in June 2010. 

• Hospira has Levophed on shortage due manufacturing delays. 



Nefazodone Tablets 



Nefazodone tablets, Teva 

50 mg, 100 count (NDC 00093-7178-01) 

250 mg, 60 count (NDC 00093-1026-06) 


• Teva could not provide a reason for the shortage. 



81

Methylprednisolone Acetate Injection 



Methylprednisolone acetate injection, Sandoz 


40 mg/mL, 1 mL vials, packages of 10 (NDC 00781-3131-95) 





Methylprednisolone acetate injection, Teva 








Depo-Medrol injection, Pfizer 



• Sandoz, Teva, and Pfizer could not provide a reason for the shortage. 



Granisetron Hydrochloride Injection 



Granisetron Hydrochloride Injection, APP 

0.1 mg/mL, 1 mL vial (NDC 63323-0317-01) 



Granisetron Hydrochloride Injection, Sagent 



Granisetron Hydrochloride Injection, Teva 





• Akorn discontinued granisetron 0.1 mg/mL 1 mL vials in August, 2011. NDC codes 

changed for the 1 mg/mL presentations during this time period as well. 

• Apotex, Baxter and Sandoz discontinued their granisetron hydrochloride presentations. 


• Bedford discontinued granisetron in May, 2011 to concentrate on the manufacturing of 


• Roche discontinued Kytril 0.1 mg/mL and 1 mg/mL 1 mL vials in October, 2009. They 

82

discontinued the 1 mg/mL 4 mL vials in July 2010. 


• Wockhardt discontinued granisetron hydrochloride injection 0.1 mg/mL 1 mL vials in 

early, 2010. 

• Sagent has granisetron on shortage due to increased demand for the product. 



Gentamicin injection 



Gentamicin 10 mg/mL injection, APP 

2 mL multi-dose vial (NDC 63323-0513-02) - discontinued 

Gentamicin 40 mg/mL injection, Hospira 

2 mL vial (NDC 00409-1207-03) 

Gentamicin premixed bags, Hospira 

1.2 mg/mL, 60 mg/50 mL premixed bags (NDC 00409-7879-13) 



1 mg/mL, 100 mg/100 mL premixed bags (NDC 00409-7889-23) 


• Hospira has gentamicin on shortage due to increased demand and manufacturing delays. 

• APP had gentamicin on shortage due to increased demand. APP discontinued their 10 

mg/mL 2 mL multi-dose vial in mid-2011. 



Cefaclor Suspension 



Cefaclor Suspension 125 mg/5 mL, Ranbaxy 

75 mL bottle (NDC 63304-0954-01) 

150 mL bottle (NDC 63304-0954-02) 

Cefaclor Suspension 250 mg/ 5 mL, Ranbaxy 

75 mL bottle (NDC 63304-0956-01) 

150 mL bottle (NDC 63304-0956-02) 

Cefaclor Suspension 375 mg/ 5 mL, Ranbaxy 

50 mL bottle (NDC 63304-0957-03) 

100 mL bottle (NDC 63304-0957-04) 


• Cefaclor suspension is one of 30 generic products from Ranbaxy that had an FDA import 

ban. 

• There are no other manufacturers of cefaclor suspension. 



83

Calcium Chloride Injection 



Calcium Chloride 100 mg/mL Injection, Hospira 

100 mg/mL, 10 mL LifeShield syringe (NDC 00409-4928-34) 



calcium chloride in April, 2011. 


• Hospira has calcium chloride on shortage due to manufacturing delays. 



Acetylcysteine Inhalation Solution 



Acetylcysteine inhalation solution, American Regent 

100 mg/mL, 10 mL (NDC 00517-7510-03) 

Acetylcysteine inhalation solution, Hospira 

100 mg/mL, 30 mL (NDC 00409-3307-03) 

200 mg/mL, 30 mL (NDC 00409-3308-03) 

Acetylcysteine inhalation solution, Roxane Labs 

100 mg/mL, 10 mL (NDC 00054-3027-02) 

100 mg/mL, 30 mL (NDC 00054-3025-02) 

200 mg/mL, 10 mL (NDC 00054-3028-02) 

200 mg/mL, 30 mL (NDC 00054-3026-02) 


• American Regent had temporarily suspended distribution of most drug products in April, 

2011. 


• Roxane Labs cannot provide a reason for the shortage of acetylcysteine inhalation 

solution. 

• Hospira has acetylcysteine inhalation solution on shortage due to manufacturing delays. 



Vancomycin Hydrochloride Injection 



Vancomycin hydrochloride injection, Mylan Institutional 

1 gram vial (NDC 10139-0501-12) - NDC discontinued 

Vancomycin hydrochloride injection, Hospira 

5 gram vial (NDC 00409-6509-01) 

5 gram Novaplus vials (NDC 00409-6509-49) 

10 gram vial (NDC 00409-6510-01) 

Vancomycin hydrochloride injection, APP 

5 gram vial (NDC 63323-0295-61) 

84

10 gram vial (NDC 63323-0314-61) 

Vancomycin hydrochloride injection, Pfizer 

5 gram vials (NDC 00069-2590-01) 

10 gram vials (NDC 00069-2599-01) 


• Hospira has vancomycin on shortage due to manufacturing delays. 

• APP has vancomycin injection on shortage due to increased demand. 

• Akorn has sold their vancomycin products to Pfizer and stopped distributing on April, 29, 

2011. 

• Mylan Institutional (formerly Bioniche) has acquired multiple products from 

Generamedix, including vancomycin hydrochloride. 

• Pfizer acquired multiple products from Akorn, including vancomycin hydrochloride in 

early-May, 2011. 



Torsemide Injection 



Torsemide injection, American Regent 




• Roche discontinued Demadex injection for business reasons. Demadex tablets are not 

affected by this shortage. 

• Bedford has approval for torsemide injection, but has not yet launched the product. 

• American Regent had temporarily suspended distribution of most drug products 

presentations in April, 2011. 




Protamine Sulfate 



Protamine Sulfate 10 mg/mL, American Pharmaceutical Partners (APP) 

5 mL vials (NDC 63323-0229-05) 


25 mL vials (NDC 63323-0229-30) 



• APP has protamine on shortage due to increased demand. 

• There are no other manufacturers of protamine sulfate. 



85

Phytonadione (Vitamin K) Injection 



Vitamin K injection, contains benzyl alcohol, Hospira 

1 mg/0.5 mL ampule (NDC 00409-9157-01) 

10 mg/mL, 1 mL ampule (NDC 00409-9158-01) 

Vitamin K injection, contains polysorbate 80 and propylene glycol, Amphastar 

1 mg/0.5 mL, MINIJET prefilled syringe (NDC 00548-1140-00) - discontinued 


• Hospira has vitamin K injection on shortage due to manufacturing delays. 

• Amphastar has vitamin K injection on shortage due to increased demand. The company 

has ramped up production in an effort to meet demand. Amphastar discontinued the 

vitamin K MINIJET syringes in April 2012. 



Lidocaine Injection 



Lidocaine 0.4% and Dextrose 5% 

Lidocaine 0.4% and Dextrose 5%, Hospira 



Lidocaine 0.4% and Dextrose 5%, Baxter 


4 mg/mL, 250 mL premixed bag (NDC 00338-0409-02) - discontinued 

Lidocaine 0.4% and Dextrose 5%, BBraun 



Lidocaine 0.5% 

Xylocaine 0.5% injection, APP 


Xylocaine 0.5% - MPF injection, APP 


Lidocaine 0.5%, Hospira 

5 mg/mL, 50 mL SD Tear Top Vial, preservative-free (NDC 00409-4278-01) 

Lidocaine 0.8% and Dextrose 5% 

Lidocaine 0.8% and Dextrose 5%, Hospira 


Lidocaine 0.8% and Dextrose 5%, Baxter 


8 mg/mL, 500 mL premixed bag (NDC 00338-0411-03) - discontinued 

Lidocaine 0.8% and Dextrose 5%, BBraun 


Lidocaine 1% 

Lidocaine 1% injection, APP 


86


Xylocaine 1% injection, APP 



Xylocaine 1% - MPF injection, APP 


10 mg/mL, 2 mL glass ampule (NDC 63323-0492-80) 

10 mg/mL, 5 mL glass ampule (NDC 63323-0492-89) 



10 mg/mL, 30 mL vial, sterile pack (NDC 63323-0492-31) 

Lidocaine 1% injection, Hospira 




10 mg/mL, 2 mL preservative-free glass ampule (NDC 00409-4713-32) 

10 mg/mL, 5 mL preservative-free glass ampule (NDC 00409-4713-02) 

10 mg/mL, 30 mL preservative-free vial, sterile pack (NDC 00409-4270-01) 

10 mg/mL, 5 mL Ansyr plastic emergency syringes (NDC 00409-9137-05) 

Lidocaine 1.5% 

Xylocaine 1.5% - MPF injection, APP 



Lidocaine 1.5% injection, Hospira 

15 mg/mL, 20 mL ampule, preservative-free (NDC 00409-4776-01) 

15 mg/mL, 20 mL sterile pack, glass ampule, preservative-free (NDC 00409-4056-01) 

Lidocaine 2% 

Lidocaine 2% injection, Amphastar IMS 

20 mg/mL, 5 mL Luer-Jet emergency syringes (NDC 00548-3390-00) 

Lidocaine 2% injection, APP 


20 mg/mL, 5 mL SD Tear Top vial, preservative-free (NDC 63323-0208-05) 

20 mg/mL, 5 mL Lifeshield glass emergency syringes (NDC 00409-4903-34) 





20 mg/mL, 10 mL vial (NDC 63323-0486-10) – NDC discontinued 



Xylocaine 2% - MPF injection, APP 





20 mg/mL, 2 mL glass ampule, preservative-free (NDC 00409-4282-01) 

20 mg/mL, 5 mL vial, preservative-free (NDC 00409-2066-05) 

87




20 mg/mL, 5 mL Ansyr plastic emergency syringes (NDC 00409-1323-05) 

20 mg/mL, 5 mL Lifeshield glass emergency syringes (NDC 00409-4903-34) 

Lidocaine 4% 






• Hospira has lidocaine presentations on shortage due to manufacturing delays. 

• APP has Xylocaine and lidocaine presentations on shortage due to increased demand for 

the product. 

• Amphastar has lidocaine 2% emergency syringes on shortage due to increase demand for 

the product. 

• BBraun has lidocaine and dextrose premixed bags on shortage due to increased demand 

for the product. 

• Baxter discontinued two lidocaine and dextrose premixed bag presentations in March, 

2012. 



Potassium Phosphate Injection 



Potassium phosphate injection, American Regent 



Potassium phosphate injection, Hospira 




• Hospira was discontinuing their potassium phosphate injections but will be returning to 

market with the 5 mL and 15 mL sizes to help meet demand. 


including all potassium phosphate presentations in April, 2011. 


• American Regent has issued a statement that all lots of potassium phosphate may contain 

glass particles and filters must be used. Do not use if there are visible glass particles and 

filter all other product. 



Papaverine Injection 



88

Papaverine injection 


• Bedford and Sandoz have discontinued their papaverine presentations. 1,2 

• American Regent, the sole supplier of papaverine injection, had temporarily suspended 

distribution of all drug products in April, 2011. 




Nystatin Vaginal Tablets 



Nystatin Vaginal Tablets, Teva 

100,000 unit tablets, 15 count (NDC 51285-0534-22) 


• Teva could not provide a reason for the shortage. 

• Teva is the sole manufacturer of nystatin vaginal tablets. 



Naloxone Injection 



Naloxone 0.4 mg/mL Injection, Hospira 

1 mL vials (NDC 00409-1215-01) 


10 mL vials (NDC 00409-1219-01) 

Naloxone 1 mg/mL Injection, Amphastar 

2 mL Mini-I-Jet syringes with needles (NDC 00548-1469-00) - NDC discontinued 

2 mL Luer-Jet syringes without needles (NDC 00548-3369-00) - NDC discontinued 


• Endo discontinued its Narcan 0.02 mg/mL 2 mL ampules, 1 mg/mL 10-mL multidose 

vial, and 2-mL ampule presentations in 2005. The company discontinued their 0.4 

mg/mL presentations September, 2006. Endo would not provide a reason for the 

discontinuations. 

• Abbott discontinued naloxone 0.02 mg/mL 2 mL ampules and vials in 2001. The 

company would not provide a reason for the discontinuation. 

• There are no manufacturers of naloxone 0.02 mg/mL strength. 

• Hospira has naloxone on shortage due to manufacturing delays. 

• Amphastar changed NDC numbers in spring, 2012. 



Metoclopramide Injection 



Metoclopramide injection, Hospira 

89

5 mg/mL, 2 mL vials (NDC 00409-341401) 


• Baxter had metoclopramide injection on back order due to regulatory issues. Baxter sold 

some generic injectable products to West-Ward. West-Ward then discontinued the 

metoclopramide injection in January, 2012. 

• Teva discontinued metoclopramide injection in February, 2011. 

• Hospira discontinued metoclopramide ampules in February, 2010, and Carpuject syringes 

in May, 2009. Hospira is the only manufacturer of metoclopramide injection. 



Methotrexate Injection 



Methotrexate 25 mg/mL (with preservative), APP 

10 mL (with preservative) vial (NDC 63323-0123-10) 

2 mL vial (NDC 63323-0123-02) – discontinued 

Methotrexate 25 mg/mL injection, Bedford 





Methotrexate lyophilized powder for injection, Bedford 2 

1 gram vial (NDC 55390-0143-01) 

Methotrexate 25 mg/mL injection, Hospira 

2 mL (with preservative) vial (NDC 61703-0350-38) 

Methotrexate 25 mg/mL injection, Mylan Institutional 



40 mL preservative-free vial (NDC 10139-0062-40) 

Methotrexate 25 mg/mL injection, Sandoz 





• APP has discontinued their methotrexate 25 mg/mL (with preservative) 2 mL vials. The 

10 mL vials are on shortage due to increased demand for the product. FDA approved 

preservative-free methotrexate from APP in February, 2012. 



resumes. 


Laboratories manufactured products. Availability of products is updated on the 

Bedford Laboratories website. 

• Hospira has methotrexate on shortage due to manufacturing delays. 

• Sandoz recalled their 2 mL and 10 mL methotrexate preservative-free vials in October, 

2010. Sandoz cannot provide a reason for the current shortage. 

90

• Mylan Institutional (formerly Bioniche) cannot provide a reason for the shortage. 

• Bioniche was acquired by Mylan Institutional in September, 2011. 



Metformin Oral Tablets 



Metformin tablets, Amneal 


500 mg, 1000 count (NDC 65162-0175-11) 

850 mg, 500 count (NDC 65162-0174-50) 

1000 mg, 100 count (NDC 65162-0177-10) 

1000 mg, 500 count (NDC 65162-0177-50) 

1000 mg, 1000 count (NDC 65162-0177-11) 

Metformin tablets, Glenmark 

850 mg, 90 count (NDC 68462-0160-90) 

1000 mg, 90 count (NDC 68462-0161-90) 

Metformin tablets, Mutual Pharmaceuticals 










Metformin tablets, Mylan 

500 mg, 100 count (NDC 00378-0234-01) 







Metformin tablets, Ranbaxy 




Metformin tablets, Sandoz 

850 mg, 12 x 60 package (NDC 00781-5051-61) 

Metformin tablets, Teva 




Metformin tablets, UDL 

91





Metformin tablets, Watson 




• Apotex had metformin products unavailable due to an FDA import ban. Metformin 

immediate-release tablets are not being currently marketed at this time. 

• Sandoz has metformin products on shortage due to manufacturing delays. 

• Ranbaxy has all discontinued metformin oral tablets. 

• Mutual discontinued all metformin products. 

• Mylan has discontinued several metformin presentations. 

• Teva discontinued metformin unit dose presentations in early-August, 2011. 

• UDL discontinued metformin 500 mg 100 unit dose presentation in late-July, 2011. 

• Watson discontinued metformin 850 mg and 1000 mg presentations. 



Ketamine Injection 



Ketamine injection, Bedford 

50 mg/mL, 10 mL vial, package of 10 (NDC 55390-0475-10) 




resumes. 






Isosorbide Dinitrate Immediate Release Tablets 



Isosorbide dinitrate immediate release tablets, Major 

5 mg unit dose, 100 count (NDC 00904-2150-61) - discontinued 

10 mg unit dose, 100 count (NDC 00904-2151-61) 


Isosorbide dinitrate immediate release tablets, Sandoz 

5 mg, 100 count (NDC 00781-1635-01) 

10 mg, 100 count (NDC 00781-1556-01) 

10 mg, 1000 count (NDC 00781-1556-10) 


92

20 mg, 100 count (NDC 00781-1695-01) 


20 mg, 1000 count (NDC 00781-1695-10) 

Isosorbide dinitrate immediate release tablets, West-Ward 

10 mg, 100 count (NDC 00143-1171-01) 

10 mg, 1000 count (NDC 00143-1771-10) 

20 mg, 100 count (NDC 00143-1772-01) 

20 mg, 1000 count (NDC 00143-1772-10) 


• Major, Sandoz, and West-Ward could not provide a reason for the shortage. 

• Major discontinued isosorbide dinitrate 5 mg immediate release tablets in April, 2012. 



Indomethacin Injection 



Indomethacin sodium trihydrate lyophilized powder for injection (Indocin I.V.) 

single-dose vials, package of 3 (NDC 67386-0511-51), Lundbeck Inc. 

Indomethacin sodium lyophilized powder for injection 

single-dose vials, package of 1 (NDC 55390-0299-01), Bedford 


• Indomethacin for injection is on nationwide back order due to manufacturing issues. 








Ibuprofen lysine Injection 



NeoProfen injection, Lundbeck Inc. 

10 mg/mL ibuprofen equivalent, 2 mL vial (NDC 67386-0122-52) 


• Lundbeck has Neoprofen injection is on nationwide shortage due to manufacturing 

issues. 



Hydrocortisone Sodium Succinate Injection 



A-Hydrocort, Hospira 

100 mg vial (NDC 00409-4856-05) 

93

Solu-Cortef, Pfizer 

100 mg/2 mL Act-O-Vial, 1 count (NDC 00009-0900-13) 



1000 mg Act-O-Vial (NDC 00009-0920-03) 


• Hospira has A-Hydrocort on shortage due to capacity constraints. 

• Pfizer cannot provide a reason for the Solu-Cortef shortage. 



Enalaprilat Injection 



Enalaprilat Injection, Bedford 






resumes. 




• Teva has discontinued both of their products. 



Dextrose Injection 50% 



Dextrose Injection 50%, Amphastar (IMS) 

50 mL Luer-Jet syringes (NDC 00548-3301-00) 

Dextrose Injection 50%, Hospira 




• Amphastar has a shortage of dextrose 50% syringes due to increased demand for the 

product. 



Bumetanide Injection 



Bumetanide 0.25 mg/mL, West-Ward 

4 mL vial (NDC 10019-0506-45) - NDC number discontinued 

94

4 mL vial (NDC 00641-6008-10) 

10 mL vial (NDC 10019-0506-10) - NDC number discontinued 

Bumetanide 0.25 mg/mL, Bedford 

2 mL vial (NDC 55390-0500-02) 

4 mL vial (NDC 55390-0500-05) 

10 mL vial (NDC 55390-0500-10) 

Bumetanide 0.25 mg/mL, Hospira 

4 mL vial (NDC 00409-1412-04) 


10 mL vial (NDC 00409-1412-10) 








• Baxter discontinued bumetanide 0.25 mg/mL 2 mL vial in early-2011. 

• West-Ward acquired several Baxter products including bumetanide in mid-2011. 

• Hospira has bumetanide on shortage due to manufacturing delays. 



Atropine Sulfate Injection 



Atropine injection, Hospira 

0.05 mg/mL, 5 mL Ansyr syringe, package of 10 (NDC 00409-9630-05) 

0.1 mg/mL, 10 mL Lifeshield 21 gauge syringe, package of 10 (NDC 00409-4911-34) 

0.1 mg/mL, 10 mL Ansyr syringe, package of 10 (NDC 00409-1630-10) 

Atropine injection, American Regent 

0.4 mg/mL, 0.5 mL ampule, package of 25 (NDC 00517-0805-25) - discontinued 

0.4 mg/mL, 1 mL single-dose vial, package of 25 (NDC 00517-0401-25) 

1 mg/mL, 1 mL single-dose vial, package of 25 (NDC 00517-1010-25) 

1 mg/mL, 1 mL ampule, package of 25 (NDC 00517-0101-25)- discontinued 

Atropine injection, West-Ward (formerly Baxter) 

0.4 mg/mL, 20 mL multi-dose vial, package of 10 (NDC 10019-0250-20) - NDC discontinued 

0.4 mg/mL, 20 mL multi-dose vial, package of 10 (NDC 00641-6006-10) 



2011. 



• West-Ward acquired Baxter’s atropine injection products in May, 2011. NDC codes 




95

Sodium Bicarbonate Injection 



Sodium Bicarbonate Injection 8.4%, Amphastar (IMS) 

50 mL syringe, 10 count (NDC 00548-3352-00) 

Sodium Bicarbonate Injection 4.2%, APP 

5 mL vial (NDC 63323-0026-05) 

Sodium Bicarbonate Injection 7.5%, Hospira 


Sodium Bicarbonate Injection 8.4%, Hospira 




Neut 4% sodium bicarbonate additive solution, Hospira 

5 mL vial (NDC 00409-6609-02) 


• American Regent discontinued their sodium bicarbonate 8.4% and 7.5% 50 mL vials in 

late 2010. 

• Hospira had sodium bicarbonate on back order due to manufacturing delays and 

increased demand for product. Hospira discontinued their sodium bicarbonate 8.4% 50 

mL Ansyr syringes in August, 2009. 

• APP has sodium bicarbonate on back order due to increased demand. 

• Amphastar has sodium bicarbonate on back order due to increased demand. 



Ondansetron Injection 




Ondansetron injection, 2 mg/mL, APP 


Ondansetron injection, 2 mg/mL, Bedford 

20 mL vial (NDC 55390-0121-01) 

Ondansetron injection, 2 mg/mL, Hospira 

2 mL iSecure syringe (NDC 00406-1120-12) 


20 mL vials (NDC 00409-4759-01) 

Ondansetron injection, 2 mg/mL, West-Ward 

2 mL vials, packages of 5 (NDC 00143-9891-05) - discontinued 


20 mL vials (NDC 00143-9890-01) 

Ondansetron injection, 2 mg/mL, West-Ward (formerly Baxter) 

2 mL Novaplus vials, packages of 25 (NDC 00641-6078-25) 


Ondansetron injection, 2 mg/mL, Pfizer 


96

20 mL vials (NDC 00069-1340-02) 

Ondansetron injection, 2 mg/mL, Teva 



Ondansetron injection, 2 mg\mL, Wockhardt 


20 mL vials (NDC 64679-0727-01) 


Ondansetron injection, premixed bags, Baxter 

32 mg/50 mL (NDC 00338-1762-41) 

Ondansetron injection, premixed bags, Claris 

32 mg/50 mL (NDC 36000-0014-06) 

Ondansetron injection, premixed bags, Teva 

32 mg/50 mL (NDC 00703-7239-39) 

Ondansetron injection, premixed bags, Hospira 

32 mg/50 mL (NDC 00409-4760-24) 



• Apotex, Sagent and Cura have discontinued their ondansetron injection. 

• APP has ondansetron on shortage due to increased demand for the product. 

• Teva discontinued ondansetron 2 mL vials in 5 count packages. 

• Caraco temporarily discontinued ondansetron injection. 

• Baxter has discontinued their ondansetron injection 1 mL vial. Baxter states the shortage 

of their 2 mL and 20 mL vials was due to increased demand for the product. 

• West-Ward acquired Baxter’s ondansetron vials for injection. West-Ward discontinued 

the ondansetron 20 mL vials in October, 2011 and discontinued ondansetron 2 mg/mL 

vials in packages of 5 in Spring, 2012. 

• Bedford discontinued ondansetron 2 mg/mL 2 mL vials in May, 2011 to concentrate on 

the manufacturing of other products. 



resumes. 




• GlaxoSmithKline have discontinued Zofran 2 mL vials. 

• Hospira has ondansetron on shortage due to quality improvement issues. 

• West-Ward has ondansetron on back order due to increased demand. 


• Hospira has ondansetron premixed bags on shortage due to changes in the manufacturing 

process. 

• Claris recalled all lots of their ondansetron premixed bags in mid-2010. 

• Pfizer discontinued their ondansetron premixed bags in January, 2012. 

• Sagent has discontinued their ondansetron premixed bags. 

• Teva has ondansetron premixed bags on shortage due to manufacturing delays. 

• West-Ward has discontinued their ondansetron premixed bags. 


97


Morphine Injections 



Astramorph (preservative-free) injection, APP 

0.5 mg/mL 2 mL ampule, 10 count (NDC 63323-0291-80) 

0.5 mg/mL 10 mL vial, 5 count (NDC 63323-0291-10) 

1 mg/mL 2 mL ampule, 10 count (NDC 63323-0292-80) 


Morphine injection, West-Ward 






5 mg/mL, 1 mL vial (NDC 10019-0176-44) - NDC discontinued 






8 mg/mL, 1 mL ampule (NDC 10019-0177-68) - discontinued 

10 mg/mL, 1 mL ampule (NDC 10019-0178-68) - discontinued 

Duramorph (preservative-free), West-Ward 

0.5 mg/mL, 10 mL ampules (NDC 60977-0016-02) 


Infumorph (preservative-free), West-Ward 


Morphine injection, Hospira 

1 mg/mL 10 mL amp, package of 5 (NDC 00409-4058-21) - discontinued 

0.5 mg/mL 10 mL, preservative-free vial (NDC 00409-3814-12) 

1 mg/mL 10 mL preservative-free vial (NDC 00409-3815-12) 

1 mg/mL, 30 mL PCA vial (NDC 00409-2029-02) 

2 mg/mL, 1 mL Carpuject syringe (NDC 00409-1762-30) 

4 mg/mL, 1 mL Carpuject syringe (NDC 00409-1258-30) 

5 mg/mL, 30 mL PCA vial (NDC 00409-6028-04) 





Morphine Injection, IMS (Amphastar) 

1 mg/mL, 10 mL Luer-lock syringes (NDC 00548-3391-00) - discontinued 


• APP states the shortage is due to a change in manufacturing sites. 


• West-Ward states the shortage is due to increased demand for product. West-Ward has 

98

ecently changed old Baxter to new West-Ward NDC codes. 

• IMS (Amphastar) discontinued morphine 1 mg/mL 10 mL Luer-lock syringes in March, 

2012 due to low demand for the product. 



Milrinone Injection 



Milrinone injection, APP 



Milrinone injection, Baxter 


Milrinone injection, Bedford 









Milrinone injection, West-Ward 






Milrinone injection, West-Ward (formerly Baxter) 

1 mg/mL, 20 mL vial (NDC 00641-6067-10 



• APP states the reason for the shortage is increased demand for the product. 

• West-Ward cannot provide a reason for the shortage. 



resumes. 




• Apotex, Bioniche, and Teva discontinued milrinone 1 mg/mL vials. 

• Sanofi-Aventis discontinued Primacor injection. 



99

Midazolam Injections 



Midazolam Injection, APP 






5 mg/mL, 1 mL fill in 2 mL vial, 25 count (NDC 63323-0412-25) 

Midazolam Injection, Bedford 





5 mg/mL, 1 mL preservative-free, in 2 mL vial, 10 count (NDC 55390-0138-01) 



Midazolam Injection, Hospira 

1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 00409-2306-62) 


1 mg/mL, 2 mL Novaplus preservative-free vial, 100 count (NDC 00409-2305-21) 


1 mg/mL Novaplus 5 mL preservative-free vial (NDC 00409-2305-50) 

1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 00409-2306-12) 

1 mg/mL Novaplus 10 mL vial (NDC 00409-2587-53) 




5 mg/mL, 1 mL preservative-free Luer-Lock syringe, 10 count (NDC 00409-2307-60) 


5 mg/mL, 2 mL preservative-free Novaplus vial (NDC 00409-2308-50) 



Midazolam Injection, Sagent 








Midazolam Injection, West-Ward (formerly Baxter products) 

1 mg/mL, 2 mL vial, 10 count (NDC 10019-0028-02) - discontinued 

1 mg/mL, 2 mL dosette vial (NDC 10019-0028-03) - discontinued 



100


1 mg/mL, 2 mL latex free vial, 10 count (new NDC 00641-6057-10, old NDC 10019-0028-01) 





5 mg/mL 10 mL vial, 10 count (new NDC 00641-6060-10, old NDC 10019-0027-10) 


• West-Ward acquired Baxter’s midazolam injection products in May, 2011. NDC codes 




resumes. 




• Hospira has midazolam on shortage due to manufacturing delays and demand exceeding 

supply due to current market conditions. 

• Hospira discontinued midazolam 5 mg/mL 1 mL iSecure syringes in July 2011. 

• APP has midazolam on shortage due to increased demand. 



Metoprolol Injection 



Metoprolol 1 mg/mL Injection, American Regent 


Metoprolol 1 mg/mL Injection, APP 


Metoprolol 1 mg/mL Injection, Bedford 


5 mL Novaplus vial, 10 count (NDC 55390-0348-10) 

Metoprolol 1 mg/mL Injection, Hospira 

5 mL Carpuject syringe, 3 count (NDC 00409-1778-35) 

5 mL ampule, 12 count (NDC 00409-2285-05) 

5 mL vial (NDC 00409-1778-05) 

Metoprolol 1 mg/mL Injection, Sagent 

5 mL vial (NDC 25021-0303-05) 

Metoprolol 1 mg/mL Injection, West-Ward 




including metoprolol in April, 2011. 

• The company Regent resumed manufacturing in Shirley, New York in early-May, 2011. 

• APP and Hospira state the shortage is due to increased demand for the product. 


101


resumes. 



Laboratories website - select “Customer supply update report”. 

• Sagent has metoprolol injection on shortage due to increased demand for the product. 



Dexamethasone Sodium Phosphate 



Dexamethasone Sodium Phosphate Injection, 4 mg/mL, American Regent 

1 mL single dose vial (NDC 00517-4901-25) 

5 mL multiple dose vial (NDC 00517-4905-25) 

30 mL multiple dose vial (NDC 00517-4930-25) 

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Pfizer 

1 mL vial (NDC 00069-4547-02) 

Dexamethasone Sodium Phosphate Injection, 10 mg/mL, West-Ward (formerly Baxter products) 

1 mL vial (NDC 00641-0367-25) 


• American Regent voluntarily recalled all dexamethasone sodium phosphate due to the 

presence of particulate matter in the solution and discontinued manufacture of all 

dexamethasone 4 mg/mL presentations in March, 2011. 


dexamethasone in April, 2011. 


• APP states the dexamethasone sodium phosphate shortage was due to supply and demand 

issues. 

• Baxter could not provide a reason for the shortage. Baxter sold several products to West- 

Ward in mid-2011. 

• Pfizer launched dexamethasone sodium phosphate injection in January, 2012. 



Clarithromycin Immediate-Release Tablets 



Clarithromycin immediate-release tablets, Apotex 

250 mg, 60 count (NDC 60505-2616-06) 

500 mg, 60 count (NDC 60505-2615-06) 

Clarithromycin immediate-release tablets, Ranbaxy 

250 mg, 60 count (NDC 63304-0725-60) 

250 mg, 100 count (NDC 63304-0725-01) 

500 mg, 60 count (NDC 63304-0726-60) 

500 mg, 100 count (NDC 63304-0726-01) 

Biaxin immediate-release tablets, Abbott 

102

250 mg, 100 count unit dose (NDC 00074-3368-11) - discontinued 


• Ranbaxy has an import ban on their products. 

• Apotex import ban has been lifted, but the company has not resumed production of 

clarithromycin immediate-release tablets. 

• Abbott, Mylan, and Sandoz could not provide a reason for the shortage. 



Ciprofloxacin Immediate-Release Tablets 



Ciprofloxacin Immediate-Release Tablets, Apotex 

250 mg, 100 count (NDC 60505-1308-01) 

500 mg, 100 count (NDC 60505-1309-01) 

500 mg, 4500 count (NDC 60505-1309-07) 

750 mg, 50 count (NDC 60505-1310-04) 

750 mg, 100 count (NDC 60505-1310-01) 

Ciprofloxacin Immediate-Release Tablets, Carlsbad Technologies 

250 mg, 100 count (NDC 61442-0222-01) 

250 mg, 1000 count (NDC 61442-0222-10) 

500 mg, 100 count (NDC 61442-0223-01) 

500 mg, 500 count (NDC 61442-0223-05) 

750 mg, 100 count (NDC 61442-0224-01) 

750 mg, 400 count (NDC 61442-0224-04) 

Ciprofloxacin Immediate-Release Tablets, Dr. Reddy’s 

250 mg, 100 count (NDC 55111-0126-01) 

250 mg, 500 count (NDC 55111-0126-05) 

500 mg, 100 count (NDC 55111-0127-01) 

500 mg, 500 count (NDC 55111-0127-05) 

750 mg, 50 count (NDC 55111-0128-50) 

Ciprofloxacin Immediate-Release Tablets, Marlex 

500 mg, 100 count (NDC 10135-0475-01) 

Ciprofloxacin Immediate-Release Tablets, Ranbaxy 

250 mg, 100 count (NDC 63304-0709-01) 

500 mg, 100 count (NDC 63304-0710-01) 

750 mg, 100 count (NDC 63304-0711-01) 

750 mg, 50 count (NDC 63304-0711-50) 

Ciprofloxacin Immediate-Release Tablets, UDL 


250 mg, 100 count unit dose (NDC 51079-0402-20) - discontinued 


Ciprofloxacin Immediate-Release Tablets, West-Ward 

500 mg, 100 count (NDC 00143-9928-01) 


• Apotex had an import ban on all solid mediations including ciprofloxacin tablets. 

• Ranbaxy has an FDA import ban on several of their products manufactured in India. 

103

• Carlsbad Technology states their shortage is due to raw material shortage. 

• Marlex is unable to provide a reason for their shortage. 

• Cobalt was acquired by Watson and Watson started shipping their products in January, 

2010. 

• Major discontinued their ciprofloxacin immediate-release tablets in February, 2010. 

• Teva discontinued their ciprofloxacin immediate-release tablet, unit dose presentations in 

June, 2010. 

• Dr. Reddy cannot provide a reason for the shortage. 

• Schering has discontinued all Cipro immediate-release tablet presentations. 



Caffeine Citrate Injection and Oral Solution 



Caffeine citrate injection 

Cafcit injection, Bedford 


Caffeine citrate oral solution 

Cafcit injection, Bedford 

20 mg/mL oral solution, 3 mL vial (NDC 22390-0358-03) 



2011. 


• APP had caffeine citrate on shortage due to increased demand. 



resumes. 




• Paddock could not provide a reason for the shortage. 

• Caraco states the shortage was due to increased demand for product. 



Valsartan Tablets 



Diovan tablets, Novartis 

40 mg, 100 count, unit-dose (NDC 00078-0423-06) 

80 mg, 14000 count (NDC 00078-0358-33) 


• Novartis is the sole supplier of valsartan tablets. 

• Novartis could not provide a reason for the shortage. 



104

Granisetron Hydrochloride Injection 



Granisetron Hydrochloride Injection, APP 




Granisetron Hydrochloride Injection, Sagent 



Granisetron Hydrochloride Injection, Teva 





• Akorn discontinued granisetron 0.1 mg/mL 1 mL vials in August, 2011. NDC codes 

changed for the 1 mg/mL presentations during this time period as well. 

• Apotex, Baxter and Sandoz discontinued their granisetron hydrochloride presentations. 


• Bedford discontinued granisetron in May, 2011 to concentrate on the manufacturing of 


• Roche discontinued Kytril 0.1 mg/mL and 1 mg/mL 1 mL vials in October, 2009. They 

discontinued the 1 mg/mL 4 mL vials in July 2010. 


• Wockhardt discontinued granisetron hydrochloride injection 0.1 mg/mL 1 mL vials in 

early, 2010. 

• Sagent has granisetron on shortage due to increased demand for the product. 



Potassium Chloride Injection 



Potassium chloride for Injection, APP 





Potassium chloride for injection, Baxter 

10 mEq/1000 mL in 5% dextrose (NDC 00338-0681-04) - discontinued 

Potassium chloride for Injection, BBraun 

2 mEq/mL, 250 mL bulk package (NDC 00264-1940-20) 

Potassium chloride for injection, Hospira 




105


40 mEq/1000 mL in 5% dextrose and 0.9% sodium chloride (NDC 00409-7109-09) 


• APP states the reason for the shortage is increased demand. 

• Hospira states the reason for the shortage is manufacturing delays. 



Methazolamide Tablets 



Methazolamide Tablets, Fera 



Neptazine Tablets, Fera 



Methazolamide Tablets, Sandoz 



• Fera cannot provide a reason for the shortage. 

• Sandoz cannot provide a reason for the shortage. 



Lidocaine with Epinephrine Injection 



Lidocaine 0.5% with epinephrine 

Xylocaine 0.5% (with epinephrine 1:200,000 injection), APP 


Lidocaine 0.5% (with epinephrine 1:200,000 injection), Hospira 


Lidocaine 1% with epinephrine 

Xylocaine 1% (with epinephrine 1:200,000 injection), APP 




Xylocaine 1% - MPF (with epinephrine 1:200,000 injection), APP 




Lidocaine 1% (with epinephrine 1:100,000) injection, Hospira 



Lidocaine 1.5% with epinephrine 

Xylocaine 1.5% - MPF (with epinephrine 1:200,000 injection), APP 

106



Lidocaine 1.5% (with epinephrine 1:200,000 injection), Hospira 


Lidocaine 2% with epinephrine 

Xylocaine 2% (with epinephrine 1:200,000 injection), APP 



Xylocaine 2% - MPF (with epinephrine 1:200,000 injection), APP 




Lidocaine 2% (with epinephrine 1:100,000 injection), Hospira 




• Hospira has lidocaine with epinephrine presentations on shortage due to manufacturing 

delays. 

• APP has Xylocaine with epinephrine presentations on shortage due to increased demand 

for the product. 



Hydrocortisone Sodium Succinate Injection 



A-Hydrocort, Hospira 

100 mg vial (NDC 00409-4856-05) 

Solu-Cortef, Pfizer 

100 mg/2 mL Act-O-Vial, 1 count (NDC 00009-0900-13) - NDC discontinued 




500 mg Act-O-Vial (NDC 00009-0912-05) - NDC discontinued 

1000 mg Act-O-Vial (NDC 00009-0920-03) - NDC discontinued 


• Hospira has A-Hydrocort on shortage due to capacity constraints. 

• Pfizer recently changed their NDC numbers for the Solu-Cortef Act-O-Vials. 



Furosemide Injection 



Furosemide Injection, 10 mg/mL, Hospira 

2 mL vial (NDC 00409-6102-02) 

4 mL vial (NDC 00409-6102-04) 

107

4 mL syringe (NDC 00409-9631-04) 

2 mL Carpuject syringe (NDC 00409-1275-32) - discontinued 

10 mL syringe (NDC 00409-6102-10) 

Furosemide Injection, 10 mg/mL, American Regent 

2 mL vial (NDC 00517-5702-25) 

4 mL vial (NDC 00517-5704-25) 

10 mL vial (NDC 00517-5710-25) 

Furosemide Injection, 10 mg/mL, APP 1 

2 mL vial (NDC 63323-0280-02) 

4 mL vial (NDC 63323-0280-04) 


• APP has furosemide injection on shortage due to increased demand for the product. 


including furosemide in April, 2011. 


• Hospira has furosemide on shortage due to manufacturing delays. 

• Wockhardt has discontinued all furosemide injection presentations. 



Fluorouracil Injection 



Fluorouracil injection 50 mg/mL, Mylan Institutional 

100 mL vial (NDC 10139-0063-01) 


• APP stated fluorouracil was on allocation to prevent excessive purchases. 

• Teva stated their fluorouracil shortage was due to manufacturing delays. 

• Mylan Institutional states the reason for the shortage is that demand exceeds supply due 

to market conditions. 



Desmopressin Rhinal Tubes 



Desmopressin rhinal tubes, Ferring 

0.1 mg/mL, 2.5 mL rhinal tubes (NDC 55566-5020-01) 

DDAVP rhinal tubes, Sanofi-Aventis 

0.1 mg/mL, 2.5 mL rhinal tubes (NDC 55566-5020-01) 


• Ferring has desmopressin rhinal tubes on shortage due to manufacturing delays. 

• Sanofi-Aventis cannot provide a reason for the shortage of DDAVP rhinal tubes. 



108

Ampicillin Sulbactam 



Ampicillin Sulbactam powder for injection, Hospira 


1.5 gram ADD-Vantage vial, 10 count (NDC 00409-2689-01) 


3 gram ADD-Vantage vial, 10 count (NDC 00409-2987-03) 



Unasyn powder for injection, Pfizer 

1.5 gram Add-Vantage vial, 10 count (NDC 00049-0031-83) - discontinued 

1.5 gram bottles, 10 count (NDC 00049-0022-83) - discontinued 

3 gram ADD-Vantage vial, 10 count (NDC 00049-0032-83) - discontinued 

3 gram bottle, 10 count (NDC 00049-0023-83) - discontinued 


Ampicillin Sulbactam powder for injection, Sagent 




Ampicillin Sulbactam powder for injection, West-Ward 

1.5 gram vial, 10 count (NDC 10019-0631-01) – NDC discontinued 

3 gram vial, 10 count (NDC 10019-0630-02) – NDC discontinued 

15 gram bulk vial, 1 count (NDC 10019-0632-03) – NDC discontinued 

1.5 gram NOVAPLUS vial, 10 count (NDC 10019-0636-01) - NDC discontinued 

3 gram NOVAPLUS vial, 10 count (NDC 10019-0637-02) - NDC discontinued 

15 gram NOVAPLUS bulk vial, 1 count (NDC 10019-0638-03) - discontinued 


1.5 gram NOVAPLUS vial, 10 count (NDC 00641-6119-10) 


3 gram NOVAPLUS vial, 10 count (NDC 00641-6120-10) 



• Hospira states that ampicillin sulbactam vials are on back order due to raw material 

shortages. 


• Sandoz states the shortage was due to increased demand for the products. 

• Pfizer discontinued Unasyn 3 gram 10 count bottles in late, 2011. Pfizer discontinued all 

Unasyn Add-Vantage vials and bottles in early 2012. 

• West-Ward acquired several Baxter products in early 2011. The company discontinued 

ampicillin sulbactam 15 gram NOVAPLUS vials in May, 2012. 



BCG Vaccine Live Intravesical 



109

TheraCys Intravesical Injection, Sanofi Pasteur 



• Sanofi Pasteur states the reason for the shortage is manufacturing delay. 

• Merck could not provide a reason for the shortage. 



110

June 2012 Drug Information Update - Pharmacy Benefits ...

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