April 2012 Drug Information Update - Pharmacy Benefits ...

April 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 3-7 

Page 7-8 

Page 8-12 

Page 12-20 

Page 20-34 

Page 34-79 

2

First-Time Generics 

GENERIC DRUG NAME 

GENERIC 

MANUFACTURER 

BRAND NAME 

APPROVAL 

DATE 

B3/Azel AC/Zinc/B6/Copper/FA Virtus Pharmace Nicazel 02/24/2012 

VIT B12/Lmefolate CA/VIT B6/B Virtus Pharmace Cerefolin 02/24/2012 

Progesterone, Micronized Teva USA Prometrium 03/02/2012 

Escitalopram Oxalate Mylan Lexapro 03/01/2012 

Ziprasidone Hcl Major Pharma Geodon 03/06/2012 

Calcitriol Perrigo Co. Vectical 03/02/2012 

Doxorubicin Hcl Liposomal Sun Pharma Glob Doxil 03/02/2012 

Escitalopram Oxalate Solution Amneal Pharma Lexapro Solution 03/16/2012 

Emollient Combination No.44 

Emollient Combination No. 53 

Prugen Pharma 

Prugen Pharma 

Hylatopic Emollient 

Foam 

Hylatopic Plus Emollient 

Foam 

03/23/2012 

03/23/2012 

Ibandronate Sodium Mylan Boniva 03/22/2012 

Gruenhaupt, Mark R.Ph. Argus Health Systems, Inc. c2005 Available from: www.argushealth.com [cited March 15, 2012]. 


New Drug Entities 

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES 

PRENATAL 

VITAMIN 

PREPARATIONS 

VITAMED MD 

PLUS RX 

COMBO. PKG 

PRENATAL 

NO.39/IRON/FA#6/DHA 

30-1-300MG 

New 

Combination 

LOCAL ANESTHETICS 

BUPI-VACAINE HCL- 

0.9% NACL DISP SYRIN 

BUPIVACAINE HCL /0.9% 

NACL/ PF 

50MG/ 20ML 

New Strength 


ROPI-VACAINE HCL- 


ROPIVACAINE HCL IN 

0.9% NACL/PF 

100MG/ 20ML 

New Strength 


BUPI-VACAINE HCL- 


BUPIVACAINE HCL /0.9% 

NACL/ PF 

150MG/ 30ML 

New Strength 

ANALGESICS, NARCOTICS 

HYDROCODONE- 

ACETAMINOPHEN 

SOLUTION 

HYDROCODONE BIT/ 

ACETAMINOPHEN 

7.5-325/ CP New Strength 

SYMPATHOMIMETIC 

AGENTS 

PHENYLEPHRINE HCL- 

D5W IV PLAST. BAG 

PHENYLEPHRINE HCL/ 

D5W/ PF 

8 MG/ 100ML New Strength 

ANTI-PSORIATICS AGENTS 

ZITHRANOL SHAMPOO 

(G) 

ANTHRALIN 

MICRONIZED 

1% New Dosage Form 

3

TOPICAL ANTIFUNGALS NAFTIN CREAM (G) NAFTIFINE HCL 2% New Strength 

ANTI-NEOPLASTIC-MTOR 

KINASE INHIBITORS 

AFINITOR TABLET EVEROLIMUS 7.5 MG New Strength 

IMMUNOMODULATORS ZYCLARA CRM MD PMP IMIQUIMOD 3.75% New Dosage Form 

MIOTICS/ OTHER INTRAOC. 

PRESSURE REDUCERS 

ZIOPTAN OPHTH 

DROPERETTE 

TAFLUPROST/ PF 0.0015% New Entity 

TOPICAL ANTI-NEOPLASTIC 

& PRE-MALIGNANT LESION 

AGNTS 

TOPICAL ANTI-NEOPLASTIC 

& PRE-MALIGNANT LESION 

AGNTS 

PICATO GEL (EA) INGENOL MEBUTATE 0.015% New Entity 

PICATO GEL (EA) INGENOL MEBUTATE 0.05% New Entity 

CEPHALOSPORINS – 1 ST 

GENERATION 

CEFAZOLIN IV 

PIGGYBACK 

CEFAZOLIN SODIUM/ 

DEXTROS, ISO 

2 G/ 50 ML New Strength 

ANTIVIRALS, HIV-SPECIFIC, 

FUSION INHIBITORS 

FUZEON SUB-Q VIAL ENFUVIRTIDE 90MG New Dosage Form 

GENERAL ANESTHETICS, 

INJECTABLE 

MIDAZOLAM HCL DISP 

SYRIN 

MIDAZOLAM HCL 40 MG/ 8 ML New Strength 


INJECTABLE 

MIDAZOLAM HCL DISP 

SYRIN 

MIDAZOLAM HCL 125 MG/ 25 ML New Strength 

SKIN TISSUE REPLACEMENT 

GRAFIX PRIME TOPICAL 

SHEET 

HUMAN REGENER- 

ATIVE TISSUE MTRX 

2 CM X 2 CM New Entity 



SHEET 



5 CM X 5 CM New Entity 



SHEET 



7.5 CM X 15 CM New Entity 

MIOTICS/ OTHER INTRAOC. 

PRESSURE REDUCERS 

COSOPT PF OPHTHALM 

DROPERETTE 

DORZOLAMIDE/ 

TIMOLOL/ PF 

2% - 0.5% New Formulation 

ANTI-ARRHYTHMICS 

LIDOCAINE HCL DISP 

SYRIN 

LIDOCAINE HCL/ PF 30MG/ 3 ML New Strength 


INJECTABLE 

KETAMINE HCL DISP 

SYRIN 

KETAMINE HCL 

100 MG/ ML 

New Route and 

Dosage Form 

4


INJECTABLE 

MIDAZOLAM HCL – 


MIDAZOLAM HCL IN 

0.9% NACL/ PF 

0.5 MG/ ML New Strength 

ANTI-ANXIETY DRUGS DIAZEPAM SOLUTION DIAZEPAM 5 MG/ CUP 

New Strength and 

Dosage Form 


MORPHINE SULFATE- 

0.9% NACL IV VIAL 

MORPHINE SULFATE IN 

0.9% NACL 

1 MG/ ML (1) New Dosage Form 


FENTANYL CITRATE- 


FENTANYL CITRATE – 

0.9% NACL/ PF 

10 MCG/ ML New Dosage Form 


TRAMADOL HCL CPMP 

25-75 

TRAMADOL HCL 150 MG New Strength 


ROPI-VACAINE HCL- 


ROPIVACAINE HCL IN 

0.9% NACL/PF 

40MG/ 20ML 

New Strength 


SUBSYS SUBLINGUAL 

SPRAY 

FENTANYL 100 MCG New Dosage 



SPRAY 




SPRAY 




SPRAY 




SPRAY 




SPRAY 




SPRAY 



AGENTS 


D5W IV PLAST. BAG 


D5W/ PF 

50 MG/ 250ML New Strength 

ANTI-HISTAMINES – 1 ST 

GENERATION 

DIPHENHYDRAMINE – 

NS IV PIGGYBACK 

DIPHENHYDRAMINE IN 

0.9% NACL 

25 MG/ 50ML 

New Dosage Form 

and Route 

ANTI-HISTAMINES – 1 ST 

GENERATION 

DIPHENHYDRAMINE – 

NS IV PIGGYBACK 

DIPHENHYDRAMINE IN 

0.9% NACL 

50 MG/ 50ML 

New Dosage Form 

and Route 

5

PRENATAL 

VITAMIN 

PREPARATIONS 

VITA-MEDMD ONE RX 

CAPSULE 

PRENATAL NO.25/ IRON/ 

FA #6/ DHA 

30-1-200MG 

New 

Combination 

PEDIATRIC VITAMIN 

PREPARATIONS 

TRI-VI-FLOR DRPS SP 

MP 

PED MV A, C, D3 #38 W- 

FLUORIDE 

0.25 MG/ ML 

New Combination 

and Dosage Form 

PEDIATRIC VITAMIN 

PREPARATIONS 

TRI-VI-FLOR DRPS SP 

MP 

PED MV A, C, D3 #38 W- 

FLUORIDE 

0.5 MG/ ML 

New Combination 



LIDOCAINE HCL DISP 

SYRIN 

LIDOCAINE HCL/ PF 200MG/ 20ML New Strength 


INHALANT 

ISOFLURANE 

INHALATION LIQUID 

ISOFLURANE 99.9% New Strength 


INJECTABLE 

MIDAZOLAM HCL – 

0.9% NACL IV PLAST. 

BAG 

MIDAZOLAM HCL IN 

0.9% NACL 

0.5 MG/ ML New Dosage Form 

SEDATIVE-HYPNOTICS, NON- 

BARBITURATE 

INTER-MEZZO TAB 

SUBL 

ZOLPIDEM TARTRATE 

1.75 MG 

New Strength, Route 


SEDATIVE-HYPNOTICS, NON- 

BARBITURATE 

INTER-MEZZO TAB 

SUBL 

ZOLPIDEM TARTRATE 

3.5 MG 




MORPHINE SULFATE – 

0.9% NACL PCA SYRIN 

MORPHINE SULFATE/ 

0.9% NACL/ PF 

50 MG/ 25 ML New Strength 


HYDROMORPHONE HCL 

– NS DISP SYRIN 

HDROMORPHONE HCL 

IN 0.9% NACL 

0.5 MG/ ML New Dosage Form 

ANALGESIC, NON- 

SALICYLATE & 

BARBITURATE COMB. 

ORBIVAN CF TABLET 

BUTALBITAL/ 

ACETAMINOPHEN 

50MG-300MG 

New Strength 


AGENTS 


NS DISP SYRIN 


0.9% NACL/ PF 

20MG/ 50ML 

New Strength 

GLUCOCORTICOIDS 

DEXAMETHASONE NS 

IV PIGGYBACK 

DEXAMETHASONE IN 

0.9% NACL 

20MG/ 50ML 



GLUCOCORTICOIDS 

DEXAMETHASONE NS 

IV PIGGYBACK 

DEXAMETHASONE IN 

0.9% NACL 

10MG/ 50ML 



TOPICAL LOCAL 

ANESTHETICS 

LIDOCAINE TOPICAL 

OINT 

LIDOCAINE 5% New Strength 

TOPICAL ANTI- 

INFLAMMATORY 

STEROIDAL 

AQUA GLYCOLIC HC 

COMBO. PKG 

HYDROCORTISONE/ 

SKIN CLNSR #25 

2% New Combination 


6



New Indications (Existing Drugs) 

AVONEX® PEN 

February 28, 2012 

FDA Approves AVONEX® PEN and Dose Titration Regimen 

Dosing Enhancements May Improve Treatment Experience for Patients Receiving AVONEX® 

(interferon beta-1a) for Multiple Sclerosis 

Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved two 

separate dosing innovations designed to improve the treatment experience for patients receiving once-aweek 

AVONEX for relapsing forms of multiple sclerosis (MS). AVONEX PEN, the first intramuscular 

(IM) autoinjector approved for MS, incorporates a smaller needle and easier administration to help 

patients reduce anxiety about AVONEX self-injection. A new dose titration regimen, which gradually 

escalates the dose of AVONEX at treatment initiation, reduces the incidence and severity of flu-like 

symptoms that can occur at the beginning of therapy. 

Article link: http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1666473 

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

ANGELIQ® (Drospirenone and Estradiol) Tablets 


U.S. FDA Approves Lower Dose Formulation of ANGELIQ® (Drospirenone and Estradiol) Tablets 

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration 

(FDA) has approved a lower dose formulation of ANGELIQ® (drospirenone and estradiol) tablets to treat 

moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new 

formulation contains 0.25 mg drospirenone (drsp)/0.5 mg estradiol (E2) and will be available in the U.S. 

by prescription shortly. 

Article link: http://www.prnewswire.com/news-releases/us-fda-approves-lower-dose-formulationofangeliq-drospirenone-and-estradiol-tablets-140935233.html 

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

NATAZIA 

March 15, 2012 

U.S. FDA approves Natazia as the first combined oral contraceptive to treat heavy menstrual 

bleeding (HMB) 

The U.S. Food and Drug Administration (FDA) has approved a new indication for Natazia (estradiol 

valerate and dienogest) tablets for the treatment of heavy menstrual bleeding (HMB) that is not caused by 

any diagnosed conditions of the uterus (womb), in women who choose to use a combined oral 

contraceptive for contraception. 

Article link: http://press.bayerhealthcare.com/en/press/news-details-page.php/14519/2012-0117 

Source website: http://www.bayerhealthcare.com/scripts/pages/en/index.php 

INTELENCE® 


FDA Approves INTELENCE (etravirine) Tablets for Treatment-Experienced Pediatric Patients with 

HIV-1, Following Priority Review 

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug 

Administration (FDA) has approved INTELENCE® (etravirine) to be administered in combination with 

other antiretroviral (ARV) medications for treatment of human immunodeficiency virus 1 (HIV-1) in 

treatment-experienced pediatric patients (6 years to

with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs. 

This approval, which follows FDA priority review of the company’s supplemental New Drug 

Application, expands the INTELENCE indication and makes it the only NNRTI indicated for this use in 

both treatment-experienced children and adults with resistance to an NNRTI and other ARVs. The 

approval includes a new 25mg dose to allow for weight-based dosing in pediatric patients (6 years to

Statin Drugs - Drug Safety Communication: Class Labeling Change 

[Posted 2/28/2012] 

ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs 

known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. 

Information about the potential for generally non-serious and reversible cognitive side effects and reports 

of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. 

The lovastatin label has been extensively updated with new contraindications and dose limitations when it 

is taken with certain medicines that can increase the risk for muscle injury. 

BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce 

blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as singleingredient 

products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev 

(lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and 

Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin 

extended-release), Simcor (simvastatin/niacin extended-release),and Vytorin (simvastatin/ezetimibe). 

RECOMMENDATION: Healthcare professionals should perform liver enzyme tests before initiating 

statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical 

symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. 

If an alternate etiology is not found, the statin should not be restarted. 

Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that 

may increase the risk of myopathy/rhabdomyolysis when used with lovastatin. 

Article 

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

m293670.htm 

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

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction 

Increases Risk of Muscle Injury 


ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning 

interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken 

together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The 

most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney 

failure, which can be fatal. 

BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce 

blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). HIV protease inhibitors are 

a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of 

prescription anti-viral drugs used to treat hepatitis C infection. 

RECOMMENDATION: Healthcare professionals should follow the recommendations in the prescribing 

information ( drug labels ) when prescribing HIV or HCV protease inhibitors with statins. See the FDA 

Drug Safety Communication for additional information, including a data summary. 

Article 


m294294.htm 


The MedWatch February 2012 Safety Labeling Changes posting includes 65 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/ucm294217.htm 

9

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

WARNINGS sections: 

Monthly Safety Labeling Changes includes 65 products with revisions to Prescribing Information. 

Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection 

Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets 

Angeliq (drospirenone and estradiol) tablets 

Aptivus (tipranavir) Capsules and Oral Solution 

Avalide (irbesartan/hydrochlorothiazide) tablets 

Benicar (olmesartan medoxomil) Tablets 

Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets 

Cardiogen-82 (Rubidium Rb 82 Generator) 

Crestor (rosuvastatin calcium) Tablets 

Crixivan (indinavir sulfate) Capsules 

Diovan HCT (valsartan/hydrochlorothiazide) Tablets 

EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayedrelease) 

capsules, Ery-Ped liquid and 

PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets 

Elestrin (estradiol gel) 

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets 

Famvir (famciclovir) Tablets 

Hepsera (adefovir dipivoxil) tablets 

Invirase (saquinavir mesylate) Capsules and Tablets 

Kaletra (lopinavir/ritonavir) Tablets and Oral Solution 

Lescol (fluvastatin sodium) Capsules 

Lescol XL (fluvastatin sodium) Extended-Release Tablets 

Letairis (ambrisentan) Tablets 

Lexiva (fosamprenavir calcium) tablets and oral suspension 

Lipitor (atorvastatin calcium) Tablets 

Livalo (pitavastatin) tablets 

Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets 

Mevacor (lovastatin) Tablets 

Natazia (estradiol valerate and estradiol valerate/dienogest) tablets 

Norvir (ritonavir) oral solution and tablets 

Orencia (abatacept) for injection 

Ozurdex (dexamethasone intravitreal) implant 

Patanase (olopatadine hydrochloride) Nasal Spray 

Phendimetrazine tartrate SR 105 mg capsules 

Pravachol (pravastatin sodium) Tablets 

Premarin (conjugated estrogens) Vaginal Cream 

Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated strogens 

plus medroxyprogesterone acetate) tablets 

Prezista (darunavir), Oral suspension 

Reyataz (atazanavir sulfate) Capsules 

Rituxan (rituximab) Intravenous Injection 

Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets 

Simcor (niacin ER/simvastatin) Tablets 

Tekamlo (aliskiren/amlodipine) tablets 

Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets 

Valturna (aliskiren/valsartan) tablets 

Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets 

Vasotec (enalapril maleate) Tablets 

Viracept (nelfinavir mesylate) Oral Powder 

10

Vytorin (ezetimibe/simvastatin) Tablets 

Xalkori (crizotinib) Capsules 

Yasmin (drospirenone/ethinyl estradiol) tablets 

Zocor (simvastatin) Tablets 

Zyvox (linezoid) Tablets and Oral Suspension 

Article link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm 


Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates 


ISSUE: Eagle Pharmaceuticals Inc., supplier to The Medicines Company, issued a voluntary recall of all 

four (4) lots of Argatroban Injection, 50 mg per 50 mL from the market due to a potential for visible 

particulates. The risk of using an injectable product with particulates includes embolization/ infarction to 

organs and potential organ complications. 

BACKGROUND: During an investigation, a visible particulate was discovered in a stability sample in 

one of the distributed lots. This discovery prompted a re-inspection of undistributed lots at the 

manufacturing site. Upon this re-inspection, a small number of visible particulates were discovered in 

several vials. The affected products include: NDC# 42367-203-07 (single unit), NDC# 42367-203-84 (10 

pack) 

RECOMMENDATION: Eagle Pharmaceuticals Inc. directed The Medicines Company to arrange for the 

return of the affected product lots from all services and facilities. See the Press Release for a listing of 

affected lots. 

Article 

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


Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, 

Potential Risk of Abnormal Heart Rhythms 


ISSUE: FDA is clarifying dosing and warning recommendations for the antidepressant Celexa 

(citalopram hydrobromide; also available in generic form). In August 2011, FDA issued a Drug Safety 

Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per 

day because it could cause potentially dangerous abnormalities in the electrical activity of the heart. 

Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT 

prolongation, but because it may be important for some of those patients to use citalopram, the drug label 

has been changed to describe the particular caution that needs to be taken when citalopram is used in such 

patients. The revised drug label also describes lower doses that should be used in patients over 60 years of 

age. 

BACKGROUND: Celexa (citalopram hydrobromide; also available in generic form) is in a class of 

antidepressants called selective serotonin reuptake inhibitors (SSRIs). 

RECOMMENDATIONS: 

• Citalopram is not recommended for use at doses greater than 40 mg per day because such doses cause 

too large an effect on the QT interval and confer no additional benefit. 

• Citalopram is not recommended for use in patients with congenital long QT syndrome, bradycardia, 

hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. 

• Citalopram use is also not recommended in patients who are taking other drugs that prolong the QT 

interval. 

• The maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment, 

patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients 

who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors 

lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade 

de Pointes. 

11

See the FDA Drug Safety Communication for additional recommendations for healthcare professionals 

and patients. 

Article 


m297624.htm 

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

Studies 

Study questions antidepressant-suicide link 


The Food and Drug Administration has a blanket warning on antidepressant medications stating 

they increase the risk of suicidal thoughts and behaviors among kids and young adults, but a new 

review of clinical data finds no link between suicide and at least two of the medications. 

Article link: http://news.yahoo.com/study-questions-antidepressant-suicide-221901798.html 

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

Vertex Stays in HepC Game, as All-Oral Combo Passes Small Study 


Vertex Pharmaceuticals, some investors theorized in recent months, was about to be left in the 

dust by other companies with more effective drugs in development against hepatitis C. Today, 

Vertex released some clinical trial data which just might make some folks wait a minute before 

declaring this story to be “Game Over.” 

Article link: http://www.xconomy.com/boston/2012/02/23/vertex-stays-in-hepc-game-as-alloralcombo-passes-small-study/ 

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

Certain Antipsychotics Up Risk of Death for Patients With Dementia: Study 


While the drugs are often necessary, new comparison should help doctors balance risks, benefits 

Compared to other antipsychotic drugs, haloperidol (Haldol) raises the risk of death in elderly 

patients with dementia, a new study finds. 

Article link: http://consumer.healthday.com/Article.asp?AID=662042 

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

Takeda’s TAK-875 Fights Diabetes as Well as Older Drug in Study 


Takeda Pharmaceutical’s experimental diabetes drug lowered blood sugar as much as an older 

generic medicine with fewer side effects, a company- sponsored study found. 

Article link: http://www.bloomberg.com/news/2012-02-26/takeda-s-tak-875-fights-diabetesaswell-as-older-generic-drug-in-a-study.html 

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

Experimental Drug Shows Promise Against Type 2 Diabetes 


The medication appears to control blood sugar without boosting risk for hypoglycemia, study 

shows an experimental drug improves patients' blood sugar control without increasing the risk of 

12

low blood sugar (hypoglycemia) in patients with type 2 diabetes, according to the results of a 

phase 2 clinical trial. 



Sleeping Pills Linked to Raised Risk of Death, Cancer: Study 


Researchers warn against chronic use, but one expert said underlying health woes could also be a 

Factor. Prescription sleeping pills may help you get some much needed rest at night, but using 

them routinely might also make it more likely that you will die or develop certain types of 

cancer, research suggests. 



Merck Warned by FDA on Failure to Study Januvia Treatment for Side Effects 


Merck & Co. may face fines after being almost a year late with a post-market study of its 

diabetes drugs Januvia and Janumet to determine if the pills inflame the pancreas, U.S. regulators 

said. A letter posted today on the Food and Drug Administration’s website warned a subsidiary 

of the Whitehouse Station, New Jersey-based company that the diabetes medications are 

considered misbranded because Merck hasn’t completed a 3-month pancreatic safety study in 

rodents. Merck agreed to the study to gain expanded approval of the drugs and committed to 

completing it by March 15, 2011, according to the letter dated Feb. 17. 

Article link: http://www.bloomberg.com/news/2012-02-28/merck-warned-by-fda-on-failuretostudy-januvia-treatment-for-side-effects.html 

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

Forest, Richter Schizophrenia Drug Met Clinical Trial Goals 


Gedeon Richter Nyrt. and Forest Laboratories Inc. said that the experimental antipsychotic drug 

cariprazine met the goals of two late-stage clinical trials for the treatment of schizophrenia. The 

companies plan to seek approval for the drug this year to treat schizophrenia and bipolar mania, 

they said in a statement today. Richter and Forest previously reported successful late-stage trials 

for bipolar mania. 

Article link: http://www.bloomberg.com/news/2012-02-28/forest-richter-schizophrenia-drugmetclinical-trial-goals-2-.html 

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

New Drug May Help Fight Rare Bone Marrow Disorder 


Jakafi won't cure myelofibrosis, but it improves quality of life, studies find. Two new studies 

confirm that the new drug ruxolitinib can help people with the rare bone marrow disorder called 

myelofibrosis. While the drug, marketed in the United States under the brand name Jakafi, won't 

cure myelofibrosis, it can help ease symptoms, improve quality of life, and possibly improve 

survival according to the studies. 



13

Novartis Cancer Drugs Fight Deadly Ebola Virus in Lab, Researchers Find 


Two Novartis AG leukemia drugs, Gleevec and Tasigna, fought the deadly Ebola virus in 

laboratory experiments, suggesting the products could be used against a disease for which there 

are no treatments. The two medicines stopped the release of viral particles from infected cells in 

lab dishes, a step that in a person may prevent Ebola from spreading in the body and give the 

immune system time to control it, researchers from the U.S. National Institute of Allergy and 

Infectious Diseases wrote in the journal Science Translational Medicine today. 

Article link: http://www.bloomberg.com/news/2012-02-29/novartis-cancer-drugs-fightdeadlyebola-virus-in-lab-researchers-find.html 


U.S. Food and Drug Administration Extends Action Date for ELIQUIS (apixaban) by 

Three Months 


Bristol-Myers Squibb Company and Pfizer announced today that the U.S. Food and Drug 

Administration (FDA) has extended the action date by three months for the New Drug 

Application (NDA) for Eliquis® (apixaban) for the prevention of stroke and systemic embolism 

in patients with atrial fibrillation. The new Prescription Drug User Fee Act (PDUFA) goal 

date is June 28, 2012. 

Article link: http://pharmalive.com/News/index.cfm?articleid=828467# 

Source website: http://pharmalive.com/ 

Parkinson’s Drug Helps Speed Recovery After Brain Trauma, Researchers Say 


A drug for Parkinson’s disease accelerated the ability of patients with severe brain injuries to 

open their eyes and speak, providing what researchers said is the first evidence that a medical 

treatment might help speed head trauma recovery. Patients taking the medicine, amantadine, for 

four weeks regained cognitive functioning faster than those on a placebo, according to the 184- 

patient study published online yesterday in the New England Journal of Medicine. The rate of 

recovery declined in two weeks after treatment and it’s unknown whether the drug aided longterm 

improvement. 

Article link: http://www.bloomberg.com/news/2012-02-29/parkinson-s-drug-helps-speedrecoveryafter-brain-trauma-researchers-say.html 


Thalidomide Induces Complete Response in Cutaneous Lupus 


Low-dose thalidomide induces complete, sustained response for majority with refractory CLE 

Low-dose thalidomide successfully induces complete response in a majority of patients with 

refractory cutaneous lupus erythematosus (CLE), according to research published in the March 

issue of the British Journal of Dermatology. 

Article link: http://www.physiciansbriefing.com/Article.asp?AID=662192 

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

Study describes pros and cons of antidepressant use in pregnancy 


14

Some women with depression who become pregnant face a troubling decision: whether to 

continue taking antidepressant medication to keep the depression at bay even though the 

medications may harm the fetus. The latest on a series of studies on this issue, published Monday 

in the Archives of General Psychiatry, shows benefits and risks to continuing medication during 

pregnancy and concludes that more study is needed on the topic. As many as 6% of pregnant 

women take antidepressants. 

Article link: http://www.latimes.com/health/boostershots/la-heb-pregnant-antidepressants- 

20120305.0.5919035.story 

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

Estrogen-Only Hormone Therapy May Ward Off Breast Cancer 


Estrogen, a hormone known to fuel breast cancer, may protect against the disease in some cases, 

according to a study that found the therapy reduced the risk in women who took it after a 

hysterectomy. The trial of 7,645 women showed that those on estrogen, sold as Premarin by 

Pfizer Inc., for six years and then stopped were more than 20 percent less likely to develop breast 

cancer and die from the disease than those who never took the hormone therapy. The study is 

published online in the Lancet Oncology. 

Article link: http://www.bloomberg.com/news/2012-03-06/estrogen-only-hormone-therapymayprotect-against-breast-cancer.html 


Gilead Quad HIV drug causes fewer side effects 


Full details from a pivotal trial of Gilead Sciences Inc experimental Quad HIV pill show that it 

caused fewer adverse side effects than the company's current three-drug pill, Atripla. Gilead said 

last year that the trial had met its goal of showing that the four-drug Quad worked as well as 

Atripla in controlling levels of the virus that causes AIDS. 

Article link: http://www.reuters.com/article/2012/03/07/us-gilead-quadidUSTRE8261Y620120307 

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

Study finds key dementia drugs should be used more 


Pfizer's dementia drug Aricept, already commonly used to treat mild to moderate Alzheimer's 

disease, can also help patients with severe disease and should be used more widely and for 

longer, according to research published on Wednesday. British scientists who studied the 

possible longer-term benefits of giving Aricept suggested that extending treatment could help 

twice as many Alzheimer's sufferers worldwide. 

Article link: http://www.reuters.com/article/2012/03/07/us-dementiadrugsidUSTRE82621J20120307 

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

Study suggests overall benefit from antidepressants 


Despite recent debate about how well antidepressants really work in people with only mild or 

moderate depression, a new analysis of drug studies suggests they may have some benefit across 

the board. Researchers found that more patients taking Prozac or Effexor had 

15

a substantial improvement in their symptoms than those taking a drug-free placebo pill, 

regardless of how severe those symptoms were to begin with. 

Article link: http://www.reuters.com/article/2012/03/07/us-studyantidepressantsidUSTRE82623V20120307 

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

Alexion drug offers hope for rare, deadly disorder 


An experimental therapy for a rare, often fatal genetic disorder appears to offer hope for infants 

and very young children with the condition, according to data from a small clinical trial reported 

in the New England Journal of Medicine on Wednesday. The enzyme-replacement drug, asfotase 

alfa, acquired by Alexion Pharmaceuticals Inc with its $610 million purchase of Canada-based 

Enobia Pharma, could become the first approved treatment for the metabolic disease 

hypophosphatasia, or HPP. 

Article link: http://www.chicagotribune.com/health/sns-rt-us-alexionhypophosphatasiatre82621f-20120307,0,7147932.story 

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

Trial Shows Benefit in Using Prostate Cancer Drug Early 


Johnson & Johnson said Thursday that its new drug for prostate cancer was effective when used 

earlier during treatment than it is now, potentially broadening its use and also posing a 

competitive threat to a rival drug, Dendreon’s Provenge. Johnson & Johnson’s drug, called 

Zytiga, was approved in April for use in men with advanced prostate cancer who had already 

tried chemotherapy using the drug docetaxel. 

Article link: http://www.nytimes.com/2012/03/09/business/trial-shows-benefit-in-earlier-useofzytiga-for-prostate-cancer.html?_r=2 

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

Pfizer Calls Early End To Celebrex Safety Study In Children 


Pfizer Inc. has terminated a long-term safety study of its blockbuster painkiller Celebrex in 

juvenile arthritis patients, citing difficulties in recruiting patients and a low rate of adverse 

events. New York-based Pfizer had agreed to conduct the study to address safety concerns in 

connection with the U.S. Food and Drug Administration's 2006 approval of the use of Celebrex 

to treat juvenile idiopathic arthritis. The FDA said at the time the use of Celebrex by adults 

suggested the possibility of longer-term cardiovascular problems. 

Article link: http://www.nasdaq.com/article/pfizer-calls-early-end-to-celebrex-safety-studyinchildren-20120309-00729 

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

Leukemia No Longer a Death Sentence as 90% of Children Live 


Childhood leukemia, once considered a death sentence, is now curable in nine out of 10 children, 

according to a study. Five-year survival rates for children diagnosed with acute lymphoblastic 

leukemia, the most common type in the young, rose to 90 percent in the years 2000 to 2005 from 

84 percent in 1990 to 1994, according to research today in the Journal of Clinical Oncology. 

16

Survival increased for all groups of children, except for infants 1-years-old and younger, the 

study said. 

Article link: http://www.bloomberg.com/news/2012-03-12/leukemia-no-longer-a-deathsentenceas-90-of-children-live-study-shows.html 


Can Statins Prevent Parkinson's Disease? 


It's too early to say, but study suggests younger users may gain some benefit. People taking 

popular cholesterol-lowering drugs called statins may have a slightly lower risk than others of 

developing Parkinson's disease, new research suggests. This effect may be even more 

pronounced among people younger than 60, according to the study published in the March issue 

of Archives of Neurology. 



One Antibiotic Appears to Ease Severe E. Coli Infection 


Small study looked at bacteria that caused German outbreak. Patients suffering from a strain of 

E. coli that produces Shiga toxin, which can be deadly, appear to respond to the antibiotic 

azithromycin (Zithromax), according to German researchers. 



Experimental Pill May Ease Multiple Sclerosis Disability 


Latest trial shows laquinimod can also help prevent relapse. Yet another orally taken medication 

shows some promise in preventing relapse and disability for people with relapsing-remitting 

multiple sclerosis, a new report suggests. In the new study, laquinimod reduced the annual 

relapse rate by 23 percent, and disability progression by 36 percent. 



Ibuprofen may ward off altitude sickness 


Ibuprofen has been used for decades to treat pain. Now, research suggests the drug's antiinflammatory 

properties also may help prevent the piercing headaches and other symptoms of 

altitude sickness. A small new study, published this week in the Annals of Emergency Medicine, 

found that people who took four 600-milligram doses of ibuprofen over a 24-hour period in 

which they ascended to 12,570 feet above sea level were less likely to experience altitude 

sickness than people taking a placebo. 

Article link: http://thechart.blogs.cnn.com/2012/03/20/ibuprofen-may-ward-off-altitude-sickness/ 

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

Hippocrates’s 3-Cent Aspirin a Day May Keep Cancer at Bay 

Mar 21, 2012 

Aspirin, the 3-cent painkiller whose origins can be traced to Hippocrates, reduces the chances of 

17

developing or dying from cancer earlier than previously thought and also prevents tumors from 

spreading, studies showed. People who took a daily low dose of aspirin had a 24 percent lower 

rate of developing cancer after three years, according to a study in The Lancet medical journal 

today. Those who took a daily dose of any size were 37 percent less likely to die from the disease 

after five years than those who didn’t, the study found. The rate was similar for men and women. 

Article link: http://www.bloomberg.com/news/2012-03-20/hippocrates-s-3-cent-aspirin-onceaday-may-keep-cancer-away.html 


Some antipsychotic drugs may be less effective than thought, study says 

March 21, 2011 

Eight drugs used to treat schizophrenia and other psychotic illnesses may not work as well as 

doctors think they do, a new study suggests. That's because some data regarding the drugs, 

known as second-generation antipsychotic drugs, have not been published, even though the trials 

were submitted to the Food and Drug Administration (FDA) before the drugs were approved. 

Article link: http://www.foxnews.com/health/2012/03/21/some-antipsychotic-drugs-may-belesseffective-than-thought-study-says/ 

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

Merck Blood Thinner Stops Heart Attacks With Risk of Bleeding 


A study of an experimental blood thinner from Merck & Co. showed that while the drug helped 

thwart heart attacks it raised the risk of brain bleeding, a side effect that could stymie its 

approval. The three-year study of 26,449 patients who had heart attack, stroke or leg artery 

disease, found those who got Merck’s vorapaxar along with standard therapy were 13 percent 

less likely to have another heart attack or die from cardiovascular causes than those on standard 

treatment. More patients on the drug also had serious bleeding, according to data reported today 

at the American College of Cardiology meeting in Chicago. 

Article link: http://www.bloomberg.com/news/2012-03-24/merck-blood-thinner-stopsheartattacks-with-risk-of-bleeding.html 


J&J Drug Treats Lung Clots With Less Bleeding, Study Finds 


Johnson & Johnson’s blood thinner Xarelto worked as well as standard treatment in preventing 

the recurrence of blood clots in the lung with half the risk of severe bleeding, a study found. 

The 4,833-patient study, sponsored by J&J and partner Bayer AG, found that the new blood 

thinner could safely and effectively replace a more complicated two-drug regimen used to treat 

patients suffering symptoms of potentially life- threatening blood clots in the lungs. 

Article link: http://www.bloomberg.com/news/2012-03-26/j-j-drug-treats-lung-clots-withlessbleeding-study-finds.html 


How Much Aspirin Is Too Much of a Good Thing? 


More than 40 million American adults already take an aspirin a day to prevent heart disease. 

Now many more are weighing the pros and cons of daily aspirin use in light of new studies 

18

finding that it also may reduce the risk of many cancers and stop the spread of tumors. 

Article link: http://well.blogs.nytimes.com/2012/03/26/how-much-aspirin-is-too-much-of-agoodthing/?ref=science 


Drug to Cut Cholesterol Tests Better Than Statin 


An experimental drug that works in a novel way to lower cholesterol proved even more effective 

than statins and had few undesirable side effects, newly released data shows. 

The drug works by modifying the way cholesterol levels are naturally controlled. A protein 

produced in the liver helps limit the amount of LDL, or “bad” cholesterol, that liver cells can 

remove from the bloodstream. The new drug, called REGN727, is a monoclonal antibody, made 

in a laboratory, that blocks the action of that protein. 

Article link: http://www.nytimes.com/2012/03/27/health/drug-to-cut-cholesterol-level-testsbetterthan-statins.html?_r=2 


Should Cystic Fibrosis Patients Get So Many Antibiotics? 


Study suggests that less-aggressive antibiotic therapy might be better Antibiotics can prolong 

cystic fibrosis patients' lives, but the drugs also help treatment-resistant bacteria thrive in their 

lungs, a new, small study suggests. The findings from the 10-year investigation suggest, but do 

not prove, that the current standard of aggressive antibiotic treatment for cystic fibrosis patients 

may not always be the best approach. 



Low 'Bad' Cholesterol Levels May Be Linked to Cancer Risk 


There may be a link between low levels of "bad" low-density lipoprotein (LDL) cholesterol and 

increased cancer risk, according to new research. In the study, researchers looked at 201 cancer 

patients and 402 cancer-free patients. They found that cancer patients who never took 

cholesterol-lowering drugs had low LDL cholesterol levels for an average of about 19 years prior 

to their cancer diagnosis. 

Article link: http://news.yahoo.com/low-bad-cholesterol-levels-may-linked-cancer-risk- 

180207158.html 

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

Rheumatoid Arthritis Patients Who Quit Statins May Face Raised Death Risk 


Cardiovascular disease very common among these patients, experts note people suffering from 

rheumatoid arthritis who stop taking their cholesterol-lowering drugs may raise their risk of 

dying, a new study finds. In fact, those who stopped taking statins raised their chances of dying 

from cardiovascular disease by 60 percent and dying from any cause by 79 percent during the 

course of the study, the Canadian researchers reported. 



19

Merck Blood Thinner Stops Heart Attacks With Risk of Bleeding 


A study of an experimental blood thinner from Merck & Co. showed that while the drug helped 

thwart heart attacks it raised the risk of brain bleeding, a side effect that could stymie its 

approval. The three-year study of 26,449 patients who had heart attack, stroke or leg artery 

disease, found those who got Merck’s vorapaxar along with standard therapy were 13 percent 

less likely to have another heart attack or die from cardiovascular causes than those on standard 

treatment. More patients on the drug also had serious bleeding, according to data reported today 

at the American College of Cardiology meeting in Chicago. 

Article link: http://www.bloomberg.com/news/2012-03-24/merck-blood-thinner-stopsheartattacks-with-risk-of-bleeding.html 


Recalls 

PRODUCT (Class I) 

Excedrin Tension Headache (acetaminophen 500 mg, caffeine 65 mg) Caplets, packaged in a) 

100-count bottles (NDC 0067-2045-91), b) 125-count bottles (NDC 0067-2045-84), c) 250-count 

bottles (NDC 0067-2045-07). Recall # D-1219-2012 

CODE 

Lot #: a) 10087530, Exp. 3/31/2013; b) 10089902, Exp. 4/30/2013; c) 10063947, Exp. 

11/30/2011 

RECALLING FIRM/MANUFACTURER 

Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on 

January 8, 2012. Firm initiated recall is ongoing. 

REASON 

Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the 

products. 

PRODUCT (Class I) 

Treanda (bendamustine HCL) for injection, 25mg/vial, Sterile-Single Use Vial, Rx Only, NDC 

63459-0390-08. Recall # D-1254-2012 

CODE 

Lot #: TB30111, Exp 12/2012 


Recalling Firm: Cephalon, Inc., Malvern, PA, by letter on November 18, 2011 and press release 

on January 27, 2012. 

Manufacturer: Pharmachemie B.V., Haarlem, Netherlands. Firm initiated recall is ongoing. 

REASON 

Presence of Particulate Matter; Glass fragments have been reported in a single vial. 

PRODUCT (Class II) 

1) Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension), 

1,200,000 units per 2 mL, Ten Syringes (2 mL size), Rx only. NDC 60793-600-10. Recall # D- 

1204-2012 

2) Bicillin L-A (penicillin G benzathine injectable suspension), 1,200,000 units per 2 mL, Ten 

20

Syringes (2 mL size), Rx only. NDC 60793-701-10. Recall # D-1205-2012; 

3) GONAL- f RFF Pen (follitropin alfa injection) 900 IU/1.5 mL, For Subcutaneous injection, 

Rx only, NDC 44087-1114-1. Recall # D-1206-2012; 

4) PULMOZYME (DORNASE ALFA) INHALATION SOLUTION, 30 Ampules, NDC 50242- 

100-40. Recall # D-1207-2012; 

5) Rebif (Interferon beta-1a) 44 mcg/0.5 mL, 12 Single-use prefilled syringes, NDC 44087- 


6) VSL #3 DS (DOUBLE STRENGTH), 20 SACHETS, Prescription only, Product Code 45749- 

017-82, NDC 45749-017-82, Recall # D-1209-2012 

CODE 

1) Lot #: 60746; 

2) Lot #: 61331; 

3) Lot #: BA002807; 

4) Lot #: 867896; 

5) Lot #: AU000878; 

6) Lot #: 2448A11 


Recalling Firm: Kinray Inc., Whitestone, NY, by telephone on June 15, 2011 and by e-mail and 

fax on June 24, 2011. 

Manufacturers: King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN; 

Genentech Inc., South San Francisco, CA. Firm initiated recall is complete. 

REASON 

Temp Abuse: Kinray Inc. is recalling these products because a refrigeration unit at their 

distribution facility malfunctioned, causing the temperature to rise above the storage 

specification. 


OFIRMEV, (acetaminophen) injection, 1000 mg/100 mL, (10 mg/mL, For Intravenous Use 

Only, Rx Only, NDC 43825-102-01, is supplied in a 100mL glass vial, containing 1000mg 

acetaminophen (10mg/mL) OFIRMEV (acetaminophen), NDC 43825-102-01. Recall # D-1210- 

2012 

CODE 

Lot V005710, Exp. 05/12 


Recalling Firm: Cadence Pharmaceuticals, San Diego, CA, by press release and letters on 

February 6, 2012. 

Manufacturer: Baxter Healthcare Corp, Cleveland, MS. Firm initiated recall is ongoing. 

REASON 

Presence of Particulate Matter: An unidentified visible particle was found in one vial during 

routine stability testing. 


1) Assured Pain Relief for Arthritis, (Acetaminophen 650mg), 24 Caplets (NDC 45738-717-24); 

2) Consumer's Choice Pain Relief for Arthritis, (Acetaminophen 650mg), a) 100 Caplets (NDC 

45738-715-10), b) 24 Caplets (NDC 45738-715-24); 

3) Preferred plus Acetaminophen for Arthritis (Acetaminophen 650mg), 100 Caplets (NDC 

45738-716-10); 

4) Quality Choice Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 63868- 

21

089-50), b) 100 Caplets (NDC 63868-089-01); 

5) Select Brand Arthritis Pain Relief (Acetaminophen 650mg), a) 100 Caplets (NDC 15127-530- 

01) b) 24 Caplets (NDC 15127-530-24), c) 50 Caplets (NDC 15127-530-50); 

6) Premier Value Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 68019-019- 

45), b) 100 Caplets (NDC 68016-021-06). Recall # D-1211-2012 

CODE 

1) Lot # 10J745, Exp Date Sep-12; Lot # 10J746, Exp Date Sep-12; Lot # 10J747, Exp Date Sep- 

12; Lot # 10K798, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K814, Exp Date 

Oct-12; Lot # 10K799, Exp Date Oct-12; Lot # 10K816, Exp Date Oct-12; Lot # 10K861, Exp 

Date Oct-12; Lot # 10L861, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L862, 

Exp Date Nov-12; Lot # 10L863, Exp Date Nov-12; Lot # 10L891, Exp Date Nov-12; Lot # 

10L890, Exp Date Nov-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A004, Exp Date Jan-13; 

Lot # 11A062, Exp Date Jan-13; Lot # 11A061, Exp Date Jan-13; Lot # 11A062, Exp Date Jan- 

13; Lot # 11A062, Exp Date Jan-13 & Lot # 11G481, Exp Date Jul-13; 

2) Lot # 10L889, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; and Lot # 10L863, Exp 

Date Nov-12; Lot # 10L889, Exp Date Nov-12 & Lot # 11A062, Exp Date Jan-13; 

3) Lot # 10K799, Exp Date Oct-12; Lot # 10L863, Exp Date Nov-12; Lot #, 11A061, Exp Date, 

Jan-13 & Lot # 11A062, Exp Date Jan-13; 

4) Lot # 11A004, Exp Date Jan-13; Lot # 11A060, Exp Date Jan-13; Lot # 11H484, Exp Date 

Jul-13 & NDC 63868-089-50, Lot # 11A004, Exp Date Jan-13; 

5) Lot # 10K816, Exp Date Oct-12; Lot #, 10L863, Exp Date, Nov-12; Lot # 11A004, Exp Date 

Jan-13; NDC 15127-530-24, Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan-13; 

Lot # 11A062, Exp Date Jan-13; Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan- 

13 & Lot # 11A062, Exp Date, Jan-13; 

6) All Lots 


Recalling Firm: Aphena Pharma Solutions LLC, Glasgow, KY, by letters on December 2, 2011. 

Manufacturer: Advance Pharmaceutical Inc., Ronkonkoma, NY. Firm initiated recall is ongoing. 

REASON 

Marketed without an approved NDA/ANDA: The recall is due to incorrect dosage information 

indicated on the primary bottle and the outside carton labeling. The labeling contained the 

following information: take 2 caplets every 8 hours with water. This labeling exceeds the 

allowable monograph quantity of acetaminophen in an 8 hour period. 


1) DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg, 30-count bottles, Rx only; NDC 

0173-0784-01; UPC 3 0173-0784-01 8. Recall # D-1212-2012; 

2) DynaCirc CR (isradipine) Controlled Release Tablets, 10 mg, 30-count bottles, Rx only; NDC 

0173-0785-01, UPC 3 0173-0785-01 5. Recall # D-1213-2012 

CODE 

1) Lot #: 10084536, Exp 12/12; 10102915, Exp 03/13; 10102916, Exp 06/13; 10107157, Exp 

07/13; and 10108172, Exp 09/13; 

2) Lot #: 10087732, Exp 01/13; 10091069, 10094639; Exp 03/13; 10102913, Exp 07/13; and 

10109327, Exp 10/13 


Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letter dated February 3, 2012. 

Manufacturers: Novartis Consumer Health, Lincoln NB; 

22

Patheon Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing. 

REASON 

CGMP Deviations: These lots are being recalled due to compliance concerns regarding the level 

of cGMP compliance and procedural controls related to line clearance during the packaging 

process at the Novartis Consumer Health, site. 


1) Female One Series Vagifresh Moisturizing Gel, 2 fl. oz. (59mL) carton, Made in U.S.A. UPC 

Code: 689076499057. Recall # D-1214-2012; 

2) Female One Series Vagifresh Ball, 3 tablets per carton, UPC Code: 689076499156. Recall # 

D-1215-2012 

CODE 

All Lots. 


Recalling Firm: U.S.A Far Ocean Group LLC, Alhambra, CA, by press was release on January 

18, 2012 and by letter on January 25, 2012. 

Manufacturer: Essential Pharmaceutical Corp, Pomona, CA. Firm initiated recall is ongoing. 

REASON 

1) Labeling: Product contains Undeclared Active Ingredient; The recall was initiated because Far 

Ocean Group has confirmed that the Vagifresh Gel contains Benzocaine, an active ingredient for 

many anesthetic drug products. 

2) Microbial Contamination of Non-Sterile Products; Far Ocean Group and FDA lab analysis 

confirmed that the Vagifresh Ball contains bacteria that may be a potential health risk. 


Quelicin 1000, Succinylcholine Chloride, Inj., USP, 10mL single dose in 20mL Fliptop Vials, 

Rx only, NDC 0409-6970-10. Recall # D-1218-2012 

CODE 

Lot number: 02-575-EV 


Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on January 17, 2012. 

Manufacturer: Hospira, Inc., Rocky Mount, NC. Firm initiated recall is ongoing. 

REASON 

Labeling: Correct Labeled Product Mispacked; a vial of Lidocaine Hydrochloride 2% and 

Epinephrine 1:100,000 Injection, USP, 20 mL Fliptop Vial was found inside a 25 pack of 

Quelicin 1000. 


1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) 

Tablets, packaged in a) 100-count bottles (NDC 0067-2030-91), b) 250-count bottles (NDC 

0067-2030-77), and c) 300-count bottles (NDC 0067-2030-33). Recall # D-1220-2012; 


Express Gels gelcaps, packaged in 80-count Gelcaps per bottle, NDC 0067-6270-94. Recall # D- 

1221-2012; 

3) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) 

Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2039-24. Recall # D-1222- 

2012; 

23


Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2000-24. Recall # D-1223- 


5) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) 

Tablets, packaged in 250-count bottles, NDC 0067-2037-77. Recall # D-1224-2012 

CODE 

1) Lot #: a) 10091817, Exp. 5/31/2013; b) 10092843, Exp. 6/30/2013; and c) 10073080, Exp. 

6/30/2012; 

2) Lot #10089353, Exp. 04/30/12; 

3) Lot #: 10066070, 10066069, Exp. 1/31/2012; 10074660, Exp. 7/31/2012; 10101757, Exp. 

10/31/2013; 10102541, Exp. 11/30/2013; 

4) Lot #: 10085080, Exp. 1/31/2013; 

5) Lot #: 10086758, Exp 2/28/2013; 10092845, Exp 6/30/2013 


Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on 

January 8, 2012. Firm initiated recall is ongoing. 

REASON 

Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the 

products. 


1) Topiramate Tablets, 25 mg, a) NDC 0093-0155-10 (1000 count) and b) NDC 0093-0155-06 

(60 count). Recall # D-1225-2012; 

2) Topiramate Tablets, 200 mg, NDC 0093-7220-06 (60 count). Recall # D-1226-2012 

CODE 

1) a) Lot # 28T027, exp 1/2012; b) Lot # 28T030, exp 1/2012; 

2) Lot # 16T020, exp 1/2012 


Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 22, 

2011. 

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

ongoing. 

REASON 

Impurities/Degradation Products: High OOS results for Impurity. 


1) Bufferin Extra Strength Buffered Aspirin (NSAID) (aspirin buffered with calcium carbonate, 

magnesium carbonate, and magnesium oxide) coated tablets, 500 mg, packaged in a) 39-ct. 

(NDC 0067-2065-39); and b) 130-ct. bottles (NDC 0067-2065-13). Recall # D-1227-2012; 

2) Bufferin Buffered Aspirin (NSAID) Low Dose (aspirin buffered with calcium carbonate, 

magnesium carbonate, and magnesium oxide) coated tablets, 81 mg, 130-ct. bottles; NDC 0067- 


3) Bufferin Regular Strength Buffered Aspirin (NSAID) (aspirin buffered with calcium 

carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 325 mg, 130-ct. bottles; 

NDC 0067-2063-13. Recall # D-1229-2012; 

4) Excedrin Back & Body Extra Strength (acetaminophen 250 mg and aspirin 250 mg buffered 

with calcium carbonate) bi-layer caplets, packaged in a) 24-ct. bottles (NDC 0067-6238-24); b) 

24

50-ct. bottles (NDC 0067-6238-50); and c) 100-ct. bottles (NDC 0067-6238-91 and NDC 0067- 

6238-94). Recall # D-1230-2012; 

5) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) caplets, 

packaged in a) 24-ct. bottles (NDC 0067-2000-24); b) 30-ct. (24-ct. + 6-ct. bonus) bottles (NDC 

0067-2000-30); c) 50-ct. bottles (NDC 0067-2000-50); d) 100-ct. bottles (NDC 0067-2000-91 

and NDC 0067-2000-94); e) 125-ct. (100-ct. + 25-ct. bonus) bottles (NDC 0067-2000-83, NDC 

0067-2000-84, and NDC 0067-2000-86); f) 250-ct. bottles (NDC 0067-2000-07 and NDC 0067- 

2000-77); g) 300-ct. (250-ct. + 50-ct. bonus) bottles (NDC 0067-2000-55). Recall # D-1231- 


6) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) 

Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6270-20); b) 40-ct. bottles (NDC 

0067-6270-40); and c) 80-ct. bottles (NDC 0067-6270-80 and NDC 0067-6270-94). Recall # D- 


7) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) 

geltabs, 24-ct. bottles. Recall # D-1233-2012; 

8) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) tablets, 

packaged in a) 8-ct. bottles (NDC 0067-2030-08); b) 24-ct. bottles (NDC 0067-2030-24); c) 30- 

ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2030-30); d) 50-ct. bottles (NDC 0067-2030-50); e) 

100-ct. bottles (NDC 0067-2030-91 and NDC 0067-2030-94); f) 125-ct. bottles (100-ct + 25-ct. 

bonus) (NDC 0067-2030-83 and NDC 0067-2030-86); g) 200-ct. bottles (NDC 0067-2030-92); 

h) 250-ct. bottles (NDC 0067-2030-07 and NDC 0067-2030-77); i) 300-ct bottles (250-ct + 50- 

ct. bonus) (NDC 0067-2030-55 and NDC 0067-2030-57); j) 300-ct. bottles (NDC 0067-2030- 

33); k) 300-ct. club pack (3 x 100-ct. bottles) (UPC 3 0067 2423 33 7). Recall # D-1234-2012; 

9) Excedrin Menstrual Complete Express Gels (acetaminophen 250 mg, aspirin 250 mg, and 

caffeine 65 mg) gelcaps, 20-ct. bottles; NDC 0067-6341-20. Recall # D-1235-2012; 

10) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) caplets, 

packaged in a) 8-ct. bottles (NDC 0067-2039-08); b) 24-ct. bottles (NDC 0067-2039-24); c) 30- 

ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2039-30); d) 50-ct. (NDC 0067-2039-50); e) 100-ct. 

bottles (NDC 0067-2039-91 and NDC 0067-2039-94); f) 125-ct. bottles (100-ct + 25-ct. bonus) 

(NDC 0067-2039-84, NDC 0067-2039-86, and NDC 0067-2039-83); g) 200-ct. bottles (NDC 

0067-2039-92); h) 250-ct. bottles (200-ct. + 50-ct. bonus) (NDC 0067-2039-55 and 0067-2039- 

57); i) 250-ct. bottles (NDC 0067-2039-07 and NDC 0067-2039-77); j) 300-ct. bottles (NDC 

0067-2039-33); k) 300-ct. club pack (3 x 100-ct. bottles) (UPC 3 0067 2424 33 4). Recall # D- 


11) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) geltabs, 

packaged in a) 24-ct. bottles (NDC 0067-2035-24); b) 50-ct. bottles (NDC 0067-2035-50); c) 

100-ct. Twin Pack carton containing [2 x 50-ct. bottles (NDC 0067-2035-50)] (carton NDC 

0067-2035-91 and 0067-2035-93); d) 160-ct. Twin Pack carton containing [2 x 80-ct. bottles 

(NDC 0067-2035-80)] (carton NDC 0067-2035-16). Recall # D-1237-2012; 

12) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) tablets, 

packaged in a) 24-ct. bottle (NDC 0067-2037-24); b) 30-ct. bottle (24-ct. + 6-ct. bonus) (NDC 

0067-2037-30); c) 50-ct. bottle (NDC 0067-2037-50); d) 100-ct. bottle (NDC 0067-2037-91; e) 

125-ct. bottle (100-ct. + 25-ct. bonus) (NDC 0067-2037-83; f) 250-ct. bottle (NDC 0067-2037- 

77). Recall # D-1238-2012; 

13) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) caplets, packaged 

in a) 24-ct. bottles (NDC 0067-2055-24); b) 50-ct. bottles (NDC 0067-2055-50); c) 100-ct. 

bottles (NDC 0067-2055-91); and d) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2055- 


25

14) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) Express Gels 

gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6405-20); and b) 80-ct. bottles (NDC 0067- 

6405-80 and NDC 0067-6409-80). Recall # D-1240-2012; 

15) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) tablets, packaged 

in a) 8-ct. bottles (NDC 0067-2053-08); b) 24-ct. bottles (NDC 0067-2053-24); c) 30-ct. bottles 

(24-ct. + 6-ct. bonus) (NDC 0067-2053-30); d) 50-ct. bottles (NDC 0067-2053-50); e) 100-ct. 

bottles (NDC 0067-2053-91 and NDC 0067-2053-94); f) 125-ct. (100-ct. + 25-ct. bonus) (NDC 

0067-2053-83). Recall # D-1241-2012; 

16) Excedrin Sinus Headache (acetaminophen 325 mg and phenylephrine HCl 5 mg) caplets, 24- 

ct. bottles; NDC 0067-2062-24. Recall # D-1242-2012; 

17) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) caplets, packaged 

in a) 24-ct. bottles (NDC 0067-2045-24); b) 30-ct. (24-ct. + 6-ct. bonus) (NDC 0067-2045-30); 

c) 50-ct. bottles (NDC 0067-2045-50); d) 100-ct. bottles (NDC 0067-2045-91 and NDC 0067- 

2045-94); e) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2045-83 and NDC 0067-2045- 

84); and f) 250-ct. bottles (NDC 0067-2045-77 and NDC 0067-2045-07). Recall # D-1243-2012; 

18) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) Express Gels 

gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6272-20); b) 40-ct. bottles (NDC 0067-6272- 

40); and c) 80-ct. bottles (NDC 0067-6272-94). Recall # D-1244-2012; 

19) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) geltabs, 24-ct. 

bottles; NDC 0067-2050-24. Recall # D-1245-2012; 

20) Gas-X Prevention [alpha-galactosidase enzyme (aspergillus niger)] capsules, 600 GALU, 

packaged in a) 20-ct. bottles (UPC 30043-3005-208) and b) 50-ct. bottles (UPC 30043-3005- 


21) Maximum Strength NoDoz (caffeine) coated caplets, 200 mg, packaged in a) 16-ct. bottles 

(NDC 0067-2070-16); b) 36-ct. bottles (NDC 0067-2070-36); and c) 60-ct. bottles (NDC 0067- 

2070-60). Recall # D-1247-2012 

CODE 

All lots that bear expiration date of 12/20/13 or earlier and all lots that bear expiration date of 

12/20/14 or earlier. 


Novartis Consumer Health, Lincoln, NB, by press release, telephone and letters on January 8, 

2012 and letters on January 9, 2012. Firm initiated recall is ongoing. 

REASON 

CGMP Deviations: Potential for the bottles to contain foreign tablets or broken/chipped tablets; 

lack of cGMP's. 


1) Cefprozil Powder for Oral Suspension, USP 125 mg/5 mL when constituted according to 

direction, Rx only, 100 mL. NDC: 00781-6202-46. Recall # D-1249-2012 

2) Cefprozil Powder for Oral Suspension, USP 250 mg/5 mL when constituted according to 

direction, Rx only, 100 mL. NDC: 00781-6203-46. Recall # D-1250-2012 

CODE 

1) Lots BX3481 and BX3483 and 2) Lot: BX3670 


Recalling Firm: Sandoz Inc., Broomfield, CO, by letter dated January 2012. 

Manufacturer: Sandoz GmbH, Kundl, Austria. Firm initiated recall is ongoing. 

REASON 

CGMP Deviations: Batches lack manufacturing validation. 

26


1) Ventolin HFA (albuterol sulfate) 90 mcg per actuation a) 60 Actuations, NDC 0173-0682-21; 

b) 60 Actuations Sample, NDC 0173-0682-23; c) 60 Actuations Institutional Pack, NDC 0173- 

0682-24 Rx only. Recall # D-1252-2012; 

2) Ventolin HFA Inhaler (albuterol sulfate) 90 mcg per actuation NOVAPLUS - 60 Actuations, 

Rx only, NDC 0173-0682-54. Recall # D-1253-2012 

CODE 

1) Lot: 1ZP0922, 1ZP0571, 1ZP6915, 1ZP6939, 1ZP7823, 1ZP8151, 1ZP0856, 1ZP1981, 

1ZP6941, 1ZP7824, 1ZP9063; 

2)Lot numbers: 1ZP1061, 1ZP6940 and 1ZP9680 


GlaxoSmithKline Inc., Zebulon, NC, via letter on/about January 18, 2012. Firm initiated recall is 

ongoing. 

REASON 

Does Not Deliver Proper Metered Dose: The affected canisters may not contain sufficient 

propellant to deliver the labeled claim of 60 doses. 


Cytarabine for Injection USP, for Intravenous, Subcutaneous, or Intrathecal use, 1 gram, Rx 

Only, NDC 55390-133-01. Recall # D-1255-2012 

CODE 

Lot #: 2066986, Exp 03/31/2014; 2111675, Exp 04/30/2014; 2131148, Exp 05/31/2014 


Ben Venue Laboratories Inc., Bedford, OH, by letter on February 15, 2012, a press release on 

February 16, 2012 and a follow-up letter on February 17, 2012. Firm initiated recall is ongoing. 

REASON 

Lack of Assurance of Sterility 


0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx only, NDC 0409-7972-08. Recall # D- 


CODE 

Lot Code: 09-060-JT 


Hospira, Inc., Austin, TX, by letters on February 13, 2012. Firm initiated recall is ongoing. 

REASON 

Lack of Assurance of Sterility: there is a potential for solution to leak from the administration 

port of the primary container. 


Fludeoxyglucose F18 Injection, multiple-dose glass vial containing 0.74 - 11.1 GBq (20 - 300 

mCi/mL), and labeled in part ***Sterile Non-pyrogenic***Radioactive. Recall # D-1258-2012 

CODE 

Lot 6509, Exp 6:15 pm on 27 Dec 2011 


Precision Nuclear of Virginia, Salem, VA, by telephone on December 27, 2011 and by letter on 

27

December 29, 2011. Firm initiated recall is ongoing. 

REASON 

Impurities/Degradation Products: Product contains residual by-products of the manufacturing 

process which were above allowances. 


Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 

1 patch per pouch (NDC 54092-554-01), packaged in 30-count patches per box (NDC 54092- 

554-30), Rx only. Recall # D-1259-2012 

CODE 

Lot #: 47313, Exp 07/12; 47937, Exp 08/12; 47955, Exp 09/12 


Noven Pharmaceuticals, Inc., Miami FL, by letter dated March 2011. Firm initiated recall is 

ongoing. 

REASON 

Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force 

and/or the z-statistic. 


Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 

1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092- 

555-30), Rx only. Recall # D-1260-2012 

CODE 

Lot # 50890, 50894, Exp 12/12 


Noven Pharmaceuticals, Inc., Miami, FL, by letter dated September 2011. Firm initiated is 

ongoing. 

REASON 

Miscalibrated and/or Defective Delivery System: Out of Specification for mechanical peel force 

and/or the z-statistic. 


VALPROIC ACID ORAL SOLUTION, USP, 250 mg/5 mL, 16 fl oz (473 mL), Rx only, NDC 

50383-792-16 (Hi-Tech label), and NDC 0591-0426-16 (Watson label). Recall # D-1262-2012 

CODE 

Lot 604482, exp. 1/2013 


Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone on December 8, 2010 and December 

14, 2010, and by letters dated December 8, 2010. Firm initiated recall is ongoing. 

REASON 

Failed pH Specification: OOS pH (low) resulted in OOS description for cloudy, hazy, oily 

appearance of the product. 


Phenylephrine HCl Injection, USP, 1% (10 mg/mL) (50 mg/5 mL), 5 mL Vial, For Pharmacy 

Use Only, For SC, IM, or IV use, Rx Only, NDC 0517-0405-25. Recall # D-1264-2012 

CODE 

28

Lot #: 0693, Exp: 10/2012 


Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release, email, and/or fax and letter dated 

February 22, 2012. Firm initiated recall is ongoing. 

REASON 

Presence of Particulate Matter: One lot of Phenylephrine HCl Injection, USP, 1%, is being 

recalled due to the identification of visible particles found in some retain samples of this lot. 


Vidaza (azacitidine for injection), 100 mg Single-Use Vial, for Subcutaneous and Intravenous 

Use Only, Rx Only, NDC 59572-102-01. Recall # D-1265-2012 

CODE 

Lot numbers for product distributed to the following countries: Japan - Lot #: 100401, Exp. Jun- 

14; Switzerland - Lot #: 1345069B, 1345070B, 1345073A, Exp. Dec-11; 1345088A, Exp. Apr- 

12; 1859672B, 1599082B, Exp. Apr-13; 1859679A, 1859677A, Exp. Jan-14; Poland - Lot #: 

1602514B, Exp. Apr-13; Turkey - Lot #: 1345069A, Exp. Dec-11; 1345088B, 1345088C, Exp. 

Apr-12; 1859672A, Exp. Dec-13; 1599082A, Exp. Apr-13; 1859677B, Exp. Jan-14; 1859679B, 

Exp. Feb-14; Hong Kong - Lot #: 1907405, Exp. Mar-14; 1907418, Exp. Jul-14. 


Recalling Firm: Celgene Corp., Overland Park, KS, by press release on November 22, 2011 and 

e-mail between November 23/30, 2011. 

Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing. 

REASON 

Lack of Assurance of Sterility; During an inspection conducted at BVL (the manufacturing firm) 

by multiple regulatory authorities, including the FDA, manufacturing and quality concerns were 

identified, including sterility assurance concerns, therefore, this product is being recalled because 

the manufacturing firm cannot assure sterility of the product. 


Aveeno Baby Calming Comfort Lotion Net Wt. 8 oz. (227 g). Made in Canada, NDC 58232- 

0211-1. Recall # D-1266-2012 

CODE 

Lot #0161LK 


Recalling Firm: Johnson & Johnson, Skillman, NJ, by letter dated January 26, 2012 and press 

release on January 27, 2012. 

Manufacturer: Les Emballages Knowlton Inc., Knowlton, Canada. Firm initiated recall is 

ongoing. 

REASON 

Microbial Contamination of Non-Sterile Products: Product recall due to a potential for microbial 

(coagulase negative staphylococci) contamination. 


Flutamide Capsules USP, 125 mg, Rx Only, 180-count bottle, NDC 0172-4960-58. Recall # D- 


CODE 

Lot #s: J05761, Exp 11/2012; J15067, Exp 1/2013; J15229, Exp 4/2013 

29


Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on January 24, 

2012. 

Manufacturer: Cipla Ltd, Verna, Salcette, Goa, India. Firm initiated recall is ongoing. 

REASON 

Adulterated Presence of Foreign Capsule; The firm received a complaint that a Flutamide 125 

mg capsule, 180-count bottle had a foreign capsule identified as Imatinib Mesylate 100 mg 

capsule. 


Clonidine Transdermal System, USP 0.2 mg/day, 4 patches/carton, Rx only, NDC 0378-0872- 

99. Recall # D-1268-2012 

CODE 

Lot Number: 6C0074 Expiration June 2013 


Mylan Technologies, Inc., Saint Albans, VT, by letter beginning on February 24, 2012. Firm 

initiated recall is ongoing. 

REASON 

Defective Delivery System: Mechanical Peel Force yielded high OOS results. 


1) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Original (16 fl. 

oz.) NDC#: 37000-032-04, SKUs 84806240 and 84804290. Recall # D-1271-2012; 

2) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Cherry (12 fl. oz.) 

NDC#: 37000-475-12, SKU 84929877. Recall # D-1272-2012; 

3) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Max Strength (12 

fl. oz.) NDC#: 37000-019-03, SKUs 80216951 and 80216952. Recall # D-1273-2012 

CODE 

1) Lot Codes: 2017171953, Exp. Date: Dec-13 and 2017171981, Exp. Date: Dec-13; 

2) Lot Code: 2018171951, Exp. Date: Dec-13; 

3) Lot Codes: 2018171952, Exp. Date: Dec-13 and 2018171981, Exp. Date: Dec-13 


Procter & Gamble Co., Mason, OH, by letter on March 12, 2012. 

Manufacturer: Procter & Gamble Manufacturing, Greensboro, NC. Firm initiated recall is 

ongoing. 

REASON 

Microbial Contamination of Non-Sterile Products: Out of Specification (OOS) result for Purified 

Water used to rinse product contact parts during manufacturing. 

PRODUCT (Class III) 

1) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID), 24 Coated 

Tablets, NDC 50580-109-02. Recall # D-1216-2012; 

2) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID),24 Coated 

Caplets, NDC 50580-110-03. Motrin IB***Ibuprofen Tablets, USP 200 mg*** 24+6 Coated 

Caplets***. Motrin IB 24 Count Coated Caplets, Motrin IB 24+6 Coated Caplets. Cartons of 

Motrin IB Coated Caplets were also included in the following displays: TYl ES/PM CAP 24s, 

Motrin CAP 24s CU (Display case UPC# 30300450753312); Tylenol Caplet 24/Motrin Caplet 

30

24 (Display case UPC# 30300450749230); Tylenol RRG/PM 24s, Motrin CAP 24s CU (Display 

case UPC# 30300450754821); and TYl ES/PM/RRG/MOT IB/PM 24s DIST PK (Display case 

UPC# 30300450755873). Recall # D-1217-2012 

CODE 

1) Lot ADA069, Exp. 01/12; ALA168, Exp. 04/12; ALA244, Exp. 08/12; AMA286, Exp. 09/12; 

APA001, Exp. 09/12; ASA001, Exp. 10/12; 

2) Lot ACA310, Exp. 12/11; ACA460, Exp. 01/12; ADA407, Exp. 02/12; AEA262, Exp. 03/12; 

AFA226, Exp. 04/12; AJA170, Exp. 03/12; ALA037, Exp. 07/12; ALA163, Exp. 04/12; 

AMA012, Exp. 08/12; AMA331, Exp. 05/12; AMA342, Exp. 08/12; APA035, Exp. 09/12; 

ASA082, Exp. 09/12; ASA123, Exp. 10/12; ASA285, Exp. 09/12; BDA238, Exp. 11/12; 

BDA260, Exp. 01/13; BDA383, Exp. 01/13; BEA065, Exp. 01/13; BEA148, Exp. 02/13; Exp. 

03/13; BEA269, Exp. 03/13; BEA277, Exp. 03/13; BFA064, Exp.04/13; BFA144, Exp. 04/13; 

BFA244, Exp. 05/13; BHA078, Exp. 05/13; BHA147, Exp. 04/13; BHA167, Exp. 04/13; 

BHA198, Exp. 05/13; BJA164, Exp. 05/13; BJA221, Exp/. 06/13; BMA144, Exp. 08/13; 

BMA215, Exp. 08/13; BMA271, Exp. 08/13; BSA022, Exp. 07/13; BSA056, Exp. 10/13; 

CBA063, Exp. 12/13; CBA107, Exp. 12/13; CCA028, Exp. 01/14; CDA003, Exp. 02/14; 

CFA065, Exp. 01/14; CFA100, Exp. 01/14; CHA012, Exp. 01/14; CHA044, Exp. 01/14; 

CHA066, Exp. 01/14; CHA080, Exp. 05/14; CMA028, Exp. 05/14; CMA035, Exp. 05/14; 

CMA057, Exp. 05/14; CMA102, Exp. 06/14; CMA108, Exp. 05/14; ACA761, Exp. 01/12; 

ALA265, Exp. 08/12 


Recalling Firm: McNeil Consumer Healthcare, Div Of McNeil-ppc, Inc, Fort, Washington, PA, 

by letter and WEB posting on December 21, 2011. 

Manufacturer: Dr. Reddy's Laboratories Louisiana LLC, Shreveport, LA. Firm initiated recall is 

ongoing. 

REASON 

Failed USP Dissolution Test Requirements: McNeil is recalling these products because testing of 

product sample showed that some caplets may not dissolve as quickly as intended when nearing 

their expiration date. 


Bupropion Hydrochloride Extended-Release Tablets (XL), 150mg tablets,150mg, packaged in 

10-count UD tablets (NDC #68084-251-11), 10 x 10-count tablets per box (NDC 68084-251- 

01) Rx only, Recall # D-1248-2012 

CODE 

AHP Lot 110564, Exp. Date 03/31/2012; AHP Lot 103077, Exp. Date 03/31/2012; AHP Lot 

103499, Exp. Date 06/30/2012 & AHP Lot 110450, Exp. Date 03/31/2012 


Recalling Firm: American Health Packaging, Columbus, OH, by letters on January 18, 2912. 

Manufacturers: Actavis South Atlantic LLC. Sunrise, FL; 

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

REASON 

Failed USP Dissolution Requirements: American Health Packaging was notified by their 

supplier that the product is being recalled due to possible out-of-specification dissolution results 

for 8-hours stability testing point. 

31


Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL-Sterile, For the Eye Only, Rx only, 

NDC 47335-938-90. Recall # D-1251-2012 

CODE 

Lots: JKJl389A, JKJ1514A JKJ1515A. JKJ2541A, JKJ2542A, JKJ2646A, JKJ3050A, 

JKJ3425A, JKJ3126A, JKK0817A, JKK0884A, JKK0885A, JKJ2187A, JKK2268A, 

JKK2269A, JKK2315A, JKK2472A, JKK2473A 


Sun Pharmaceutical Industries Ltd., Halol, India, by letters and telephone beginning February 6, 

2012. Firm initiated recall is ongoing. 

REASON 

Impurities/Degradation Products: The total impurities results were out of specification (OOS) 

during the analysis of 18 month controlled stability sample 


Gentamicin Sulfate in 0.9% Sodium Chloride Injection, 80 mg in 50 mL single dose VIAFLEX 

Plus Container, NDC 0338-0509-41. Recall # D-1256-2012 

CODE 

Lot #: P266742, Exp. 10/12 


Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 17, 2012, 

Manufacturer: Baxter Healthcare Corp., Jayuya, PR. Firm initiated recall is ongoing. 

REASON 

Subpotent (Single Ingredient) Drug: An analytical calculation error resulted in the release of a lot 

of finished product Isotonic Gentamicin Sulfate Injection that was 2% below the approved 

concentration range. 


Cervidil (Dinoprostone) 10 mg Vaginal Insert; supplied in boxes of 6, Rx only, NDC 0456-4123- 

63, Item #194-2242. Recall # D-1261-2012 

CODE 

Lot numbers: MA09D05B, MA09H04B, MA09W02B, MA09N06B, MA09K01B, MA09K07B, 

MA09F08B, MA09F10B, MA09P05B, MA09R01B, MA09R07B, MA10D02B, MA10D03B, 

MA10W07B, MA10N05B, MA10N07B, MA10Q07B, MA10Q09B, MA10K07B, MA10K06B, 

MA10X06B, MA10F05B, MA10F06B, MA10R03B, MA10R04B, MA10B07B, MA11D06B, 

MA11W04B, MA11N05B, MA11Q02B, MA11Q08B, MA11K05B, MA11X03B, MA11K03B, 

MA08P02B and MA11W05B. 


Recall Firm: H D Smith Wholesale Drug Co., Springfield, IL, by telephone and e-mails the 

weekend of January 28-29, 2012, and by letter on February 2, 2012. 

Manufacturer: Controlled Therapeutics, Ltd., East Kilbride, UK. Firm initiated recall is ongoing. 

REASON 

Temperature Abuse; product not stored at labeled temperature. 


Brimonidine Tartrate Ophthalmic Solution 0.2% (Sterile), Each mL Contains Active: 

Brimonidine tartrate 0.2% (Sterile), 15 mL bottles, Rx only, NDC 24208-411-15. Recall # D- 


32

CODE 

Lot # 139961 


Bausch & Lomb, Inc., Tampa, FL, by letters on February 22, 2012. Firm initiated recall is 

ongoing. 

REASON 

Impurity/Degradation; 9 month stability. 


1) Squibb Kenalog Injection 10 (Triamcinolone Acetonide Injectable Suspension, USP), 50 mg/5 

mL, 10 mg/mL, 5 mL multiple vial, Rx only, NDC 0003-0494-20. Strength Product/SAP 

Package/I Description NDC Expiration No. 10 mg/mL KENALOG SINJ 10MG/ML 

(1VL.X5ML) US 0003-0494-20 SEPT 2012. Recall # D-1269-2012; 

2) Squibb Kenalog Injection 40 (Triamcinolone Acetonide Injectable Suspension, USP), 40 

mg/mL, 10 mL multiple vial, Rx only, NDC 0003-0293-28, Strength Lot Number Product/SAP 

Package/I Description NDC Expiration No. 40 mg/mL KENALOG SINJ 40MG/ML 

(1VL.X5ML) US 0003-0293-20 SEPT 2012,, 40 mg/mL KENALOG SINJ 40MG/ML 

(1VL.X10ML) US 0003-0293-28 OCT 2012, 40 mg/mL KENALOG SINJ 40MG/ML 

(1VL.X10ML) US 0003-0293-28 OCT 2012, 40 mg/mL KENALOG SINJ 40MG/ML 

(1VL.X10ML) US 0003-0293-28 OCT 2012, 40mg/mL KENALOG SINJ 40MG/ML 

(1VLX10ML) US 0003-0293-28 OCT 2012. Recall #D-1270-2012 

CODE 

1) OK65465 1131273; 

2) OK66391 1131271; OK66412 1131272, OK66414 1131272, OK66501 1131272, OL56792 

1131272 


Bristol-Myers Squibb, Anagni, Italy, by letters dated October 21, 2011 and December 14, 2011. 

Firm initiated recall is ongoing. 

REASON 

Presence of Precipitate: Atypical particle size found in vial. 


1) Enoxaparin Sodium Injection, USP, 100 mg/mL, 1 mL pre-filled Single Dose Syringe in a 

blister (NDC 0781-3500-05) packaged in 10-count Syringes in a blister per carton (NDC 0781- 

3500-69), Rx Only. Recall # D-1274-2012; 

2) Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, 0.3 mL pre-filled Single Dose Syringe in a 

blister, NDC 0781-3133-01, packaged in 10-count Syringes in a blister per carton, NDC 0781- 

3133-63, Rx Only. Recall # D-1275-2012 

CODE 

1) Lot #: 917713, Exp 08/13; 

2) Lot #: 917995, Exp 08/13 


Recalling Firm: Sandoz Inc., Broomfield, CO, by letters on February 13, 2012. 

Manufacturer: Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN. Firm initiated recall is 

ongoing. 

REASON 

Defective Container: Small defects with stopper ribs. 

33

PRODUCT (Biologics Class II) 

Hepatitis C Virus Encoded Antigen (Recombinant c200) CHIRON HCV c200 Antigen; Stock 

Number: 4392-801, 4392-802, 4392-805 (4392-805 only item distributed for this lot); (The 

product is for Further Manufacturing Use/Recombinant). Recall # B-0673-12 

CODE 

Lot # 127129 


Novartis Vaccine and Diagnostics, Inc., Emeryville, CA, by telephone, e-mail, and letter on 

December 12, 2011. Firm initiated recall is complete. 

REASON 

Hepatitis C Virus Encoded Antigen (For Further Manufacturing Use, formulated with a reduced 

concentration of Dithiothreitol (DTT) in the formulation buffer, was distributed. 

Current Drug Shortages 

Caffeine and Ergotamine Tartrate 


Products Affected - Description 

Cafergot tablets, Sandoz 

100 mg caffeine/ 1 mg ergotamine tartrate, 100 count bottle (NDC 00781-5405-01) 

Reason for the Shortage 

• Sandoz states the shortage is due to a change in the raw material plant location. 

• Sandoz is the only manufacturer of caffeine and ergotamine tablets. 

• Cypress discontinued their caffeine and ergotamine tablets in February, 2011 and West-Ward 

discontinued their product in April, 2010. 

Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=880 

Source: www.ashp.org 

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. 



Nystatin Vaginal Tablets 



Nystatin Vaginal Tablets, Teva 

100,000 unit tablets, 15 count (NDC 51285-0534-22) 

34


• Teva could not provide a reason for the shortage. 

• Teva is the sole manufacturer of nystatin vaginal tablets. 



Metronidazole Injection 



Metronidazole Injection, Claris 

500 mg/100 mL, 24 count (NDC 36000-0001-24) 

Metronidazole Injection, West-Ward 

500 mg/100 mL, 24 count (NDC 00143-9772-26) - discontinued 


• Claris has recalled all lots of their metronidazole premixed bags. This recall affects West-Ward as 

well as Claris because they manufacture product for both companies. 

• West-Ward discontinued their metronidazole injection in May, 2011. 



Amyl Nitrite Inhalation Solution 



Amyl Nitrite, Inhalation Solution, X-Gen 

0.3 mL ampule, 12 count (NDC 39822-9950-02) 


• X-Gen cannot provide a reason for the shortage. 

• James Alexander Corp is the manufacturer of amyl nitrate for X-Gen Pharmaceuticals, along with 

other distributors. 



Argatroban Injection 



Argatroban injection, Medicines Company 

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

1 mg/mL, 50 mL vials, 10 count (NDC 42367-0203-84) 


• 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. 



Droperidol Injection 


35


Droperidol injection, 2.5 mg/mL, American Regent 

2 mL vials (NDC 00517-9702-25) 

Droperidol injection, 2.5 mg/mL, Hospira 

2 mL ampule (NDC 00409-1187-01) 


• American Regent had temporarily suspended distribution of most drug products including 

droperidol injection in April, 2011. 

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

• Hospira has droperidol on shortage due to increased demand for the product. 



Calcium Chloride Injection 



Calcium Chloride 100 mg/mL Injection, Hospira 

100 mg/mL, 10 mL Ansyr syringe (NDC 00409-1631-10) 

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. 



PCA Sterile Empty Vials and Injector 


Products Affected – Description 

Lifecare PCA sterile empty vials and injector, Hospira 

30 mL sterile empty vials with injector, List Number: 06021-03 


• Hospira has Lifecare PCA sterile empty vials with injector on shortage due to manufacturing 

delays. 

• These vials are only compatible with Lifecare PCA systems. 



Enalaprilat Injection 



Enalaprilat Injection, Bedford 

1.25 mg/mL, 1 mL vial (NDC 55390-0010-10) 


Enalaprilat Injection, Hospira 



36


• Ben Venue 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. 

• 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. 

• Teva has discontinued both of their products. 



Dipyridamole Injection 



Dipyridamole 5 mg/mL injection, Teva 

2 mL vial (NDC 00703-1652-02) - discontinued 


2 mL vial, 25 count (NDC 00703-1652-04) 



• 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. 



Nystatin Oral Suspension 



Nystatin Oral Suspension, 100,000 units/mL, Qualitest 

60 mL (NDC 00603-1481-49) 

473 mL (NDC 00603-1481-58) 


• 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. 



Metaxalone Tablets 



Metaxalone tablets, CorePharma 

800 mg, 100 count (NDC 64720-0321-10) 


• CorePharma states the shortage is due to increased demand. 

• Pfizer could not provide a reason for the shortage. 

37

• Sandoz discontinued their metaxalone presentations in 2010. 



Lidocaine with Epinephrine Injection 



Lidocaine 0.5% with epinephrine 

Xylocaine 0.5% (with epinephrine 1:200,000 injection), APP 

5 mg/mL, 50 mL vial (NDC 63323-0481-57) 

Lidocaine 1% with epinephrine 

Xylocaine 1% (with epinephrine 1:200,000 injection), APP 




Xylocaine 1% - MPF (with epinephrine 1:200,000 injection), APP 



10 mg/mL, 30 mL vial, sterile pack (NDC 63323-0487-31) 

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 



Lidocaine 1.5% (with epinephrine 1:200,000 injection), Hospira 

15 mg/mL, 5 mL glass ampule, 100 count (NDC 00409-1209-65) 


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. 



Ganciclovir Capsules 


38


Ganciclovir sodium capsules, Ranbaxy 

250 mg capsules, 180 count bottles (NDC 63304-0636-28) 

500 mg capsules, 180 count bottles (NDC 63304-0637-28) 


• Ganciclovir capsules are on back order due to a raw material shortage.1 There are no other 

suppliers of ganciclovir tablets. 



Fluorouracil Injection 



Fluorouracil injection 50 mg/mL, Mylan Institutional 

10 mL vial (NDC 10139-0063-11) 

20 mL vial (NDC 10139-0063-12) 

50 mL vial (NDC 10139-0063-50) 

100 mL vial (NDC 10139-0063-01) 


• APP states fluorouracil is on allocation to prevent excessive purchases. 

• Teva states 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. 



Caffeine and Sodium Benzoate Injection 



Caffeine, anhydrous (125 mg/mL) / Sodium benzoate (125 mg/mL), American Regent 

2 mL single-dose vial, package of 10 (NDC 00517-2502-10) 


• American Regent had temporarily suspended manufacture of multiple drug products including 

caffeine and sodium benzoate injection in April, 2011.1 

• America Regent has recalled one lot (Lot #0084, expiration date: February, 2012) of caffeine and 

sodium benzoate injection due to the potential of particles in the vials.1 

• American Regent resumed manufacturing in Shirley, New York in early-May, 2011.1 

• American Regent is the sole manufacturer of caffeine and sodium benzoate injection. 

• Caffeine citrate injection is not affected by this shortage. 



Valproate Sodium Injection 



Valproate injection, Bedford 

100 mg/mL, 5 mL vials (NDC 55390-0007-10) 


39

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

Product will become available in stages as production resumes. 




• APP could not provide a reason for the shortage. 



Leflunomide Tablets 



Leflunomide tablets, Sandoz 

10 mg, 30 count (NDC 00781-5056-31) 

20 mg, 30 count (NDC 00781-5057-31) 

Leflunomide tablets, Teva 

20 mg, 30 count (NDC 00093-0174-56) 


Apotex relaunched leflunomide tablets in August 2011. 

Teva had leflunomide tablets on shortage due to unavailability of raw material. 

Sandoz had leflunomide tablets on shortage due to increased demand and delay of raw material. 



Calcitriol Injection 



Calcijex 1 mcg/mL Injection, Abbott 

1 mL ampule, 100 count (NDC 00074-8110-31) 

Calcitriol 1 mcg/mL Injection, American Regent 


Calcitriol 1 mcg/mL Injection, West-Ward 

1 mL ampule, 5 count (NDC 00143-9728-05) - discontinued 


Akorn has increased production of calcitriol injection due to increased demand for the product. 

American Regent had temporarily suspended manufacture of most drug products including 

calcitriol injection in April, 2011. 

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

West-Ward discontinued their calcitriol injection in May, 2011. 

Calcitriol capsule and oral solution presentations are available from multiple manufacturers. 



Triamterene and Hydrochlorothiazide Capsules and Tablets 



Triamterene and Hydrochlorothiazide capsules, Sandoz 

37.5 mg/25 mg, 100 count (NDC 00781-2074-01) 

40

37.5 mg/25 mg, 1000 count (NDC 00781-2074-10) 

50 mg/25 mg, 100 count (NDC 00781-2715-01) 

37.5 mg/25 mg, 500 count (NDC 00781-1123-05) 

Triamterene and Hydrochlorothiazide tablets, Mylan 

75 mg/50 mg, 100 count (NDC 00378-1355-01) 

75 mg/50 mg, 500 count (NDC 00378-1355-05) 


• 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. 

• Teva is the sole supplier of sulfamethoxazole/trimethoprim injection. 



Sterile Empty Vials 



Sterile Empty Vials, Hospira 

10 mL, 50 count (List #05816-11) 

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 could not provide a reason for the shortage. 

• 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. 



Indomethacin Injection 



41

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. 



Chorionic Gonadotropin (Human) Injection 



Pregnyl, Merck (formerly Schering-Plough) 

10,000 unit multiple-dose vial (NDC 00052-0315-10) 

Novarel, Ferring 

10,000 unit multiple-dose vial (NDC 55566-1501-01) 


• Merck (formerly Schering-Plough) states their product is on allocation to prevent use in the gray 

market. 

• Ferring has Novarel on allocation due to a supply and demand issues. 



Acyclovir Capsules and Tablets 



Acyclovir capsules and tablets, Apotex 

200 mg capsules, 100 count (NDC 60505-0042-06) 

400 mg tablets, 100 count (NDC 60505-5306-01) 




42

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 


400 mg tablets, 100 count, unit-dose (NDC 00093-8943-93) 



800 mg tablets, 100 count, unit-dose (NDC 00093-8947-93) 



Apotex has 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. 



Prochlorperazine Edisylate Injection 



Prochlorperazine injection 5 mg/mL, Bedford 


10 mL vial (NDC 55390-0077-01) 






information changes on the Bedford Laboratories website.1 

• Bedford is the sole manufacturer of prochlorperazine injection. 



Isradipine Oral Presentations 



Dynacirc CR, GSK 

5 mg extended-release tablets, 30 count (NDC 00173-0784-01) 

10 mg extended-release tablets, 30 count (NDC 00173-0785-01) 


• 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. 

43

• GlaxoSmithKline’s Dynacirc CR tablets are manufactured at the Lincoln, Nebraska plant and are 

affected by this manufacturing suspension. The majority of medications made at this facility were 

over the counter products. However, some prescription products were affected including 

contracted items from other companies. 

• The immediate release presentations are supplied by Watson Labs. 



Digoxin Injection 



Lanoxin 0.25 mg/mL injection, GlaxoSmithKline 



Lanoxin 0.1 mg/mL injection, GlaxoSmithKline 



• GlaxoSmithKline sold Lanoxin injection to Covis Pharma in late-December, 2012. 

• West-Ward acquired Baxter’s digoxin injection product in May, 2011. The company states the 

shortage was due to increased demand. 

• Sandoz discontinued their digoxin injection in March, 2011. 



Phenytoin Injection 



Phenytoin injection, 50 mg/mL, Hospira 

2 mL Carpuject syringe (NDC 00409-1844-32) 

5 mL ampule (NDC 00409-1317-02) 


• 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. 



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) 

44

500 mg, 100 count (NDC 63304-0726-01) 

Biaxin immediate-release tablets, Abbott 

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. 



Paclitaxel Injection 



Paclitaxel 6 mg/mL injection, APP 

30 mg/5 mL vial (NDC 63323-0763-05) 

150 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, Hospira 

100 mg/16.7 mL vial (NDC 61703-0342-22) 

Paclitaxel 6 mg/mL injection, Sagent 

30 mg/5 mL vial (NDC 25021-0213-05) 

100 mg/16.7 mL vial (NDC 25021-0213-07) 

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) 

Paclitaxel 6 mg/mL injection, Teva 

30 mg/5 mL vial (NDC 00703-4764-01) 


• APP has paclitaxel on shortage due to increase demand for the product. 




• 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. 

• Teva has paclitaxel on shortage due to manufacturing delays. 

• Sandoz has paclitaxel on back order due to a raw material shortage. 

• Hospira has paclitaxel on back order due to increased demand for the product. 

• Sagent cannot provide a reason for the shortage of paclitaxel. 

45

• Pfizer launched paclitaxel 100 mg and 300 mg vials in March, 2012 and will launch 30 mg vials 

in April, 2012. 



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) 

Doxorubicin lyophilized powder, Bedford 

Novaplus 10 mg vial (NDC 55390-0241-10) 

Novaplus 50 mg vial (NDC 55390-0243-01) 







• Teva has doxorubicin on shortage due to manufacturing issues. 



Choline Magnesium Trisalicylate 



Choline Magnesium Trisalicylate, Caraco 

500 mg tablets, 100 count (NDC 57664-0219-08) - discontinued 



Choline Magnesium Trisalicylate, Marlex 


46



• Caraco has discontinued their product. Product was recently seized by US Marshals due to good 

manufacturing practice violations (see news release for more information). 

• Marlex could not provide a reason for their shortage. 



Oxycodone Immediate Release Tablets and Capsules 



Immediate Release Tablets 

Oxycodone Immediate-Release Tablets, Qualitest 







Oxycodone Immediate-Release Tablets, Caraco 



Immediate Release Capsules 

Oxycodone Immediate-Release Capsules, Mallinckrodt 

5 mg capsules, 100 count (NDC 00406-0554-01) - discontinued 

Oxycodone Immediate-Release Capsules, MidLothian Labs 

5 mg, 100 count (NDC 68308-0145-10) - discontinued 


• Caraco, Mallinckrodt, Qualitest, and Xanodyne could not provide a reason for the shortage. 

• Mallinckrodt discontinued their oxycodone immediate-release 5 mg capsules in May, 2011. 



Vinblastine Injection 



Vinblastine lyophilized powder for injection, Bedford 

10 mg vial (NDC 55390-0091-10) 

Vinblastine sulfate injection, APP 








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

manufacturing delay. 

47



Tetracycline Capsules 



Tetracycline capsules, Teva 

250 mg, 100 count (NDC 00172-2416-60) 

250 mg, 100 count unit dose (NDC 00172-2416-10) 

250 mg, 1000 count (NDC 00172-2416-80) 

500 mg, 100 count (NDC 00172-2407-60) 

500 mg, 100 count unit dose (00172-2407-10) 

500 mg, 1000 count (NDC 00172-2407-80) 

Tetracycline capsules, Watson 

250 mg, 100 count (NDC 00591-2234-01) 

250 mg, 1000 count (NDC 00591-2234-10) 

500 mg, 100 count (NDC 00591-2235-01) 

500 mg, 1000 count (NDC 00591-2235-10) 


• Teva states tetracycline capsules are unavailable due to a raw material shortage. 

• Watson could not provide a reason for the shortage but tetracycline capsules have been 

unavailable since July, 2011. 



Rifampin for Injection 



Rifampin for injection, Bedford 

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


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








Pentostatin Injection 



Pentostatin 10 mg powder (NDC 55390-0244-01), Bedford 

Nipent 10 mg powder (NDC 00409-0801-01), Hospira 




48




• Hospira states the reason for the shortage is demand exceeding supply due to current market 

conditions. 



Fentanyl Injection 



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 

2 mL ampule (NDC 10019-0038-67) 

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) 

Sublimaze Injection 50 mcg/mL, Akorn 

2 mL ampules (NDC 17478-0030-02) 

5 mL ampules (NDC 17478-0030-05) 

10 mL ampules (NDC 17478-0030-20) 


• 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 will be launching Sublimaze injection in late-March, 2012. 



Etoposide Injection 


49


Etoposide solution for injection, 20 mg/mL, Accord 

5 mL vial (NDC 16729-0114-31) 

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. 






• Accord could not provide a reason for the shortage. 



Doxycycline Hyclate Injection 



Doxycycline hyclate injection, Bedford 

100 mg vial (NDC 55390-0110-10) 





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

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



Dextroamphetamine Tablets 



Dextroamphetamine tablets, Teva 




• Teva has dextroamphetamine tablets and all other amphetamine products on back order due to a 

raw material shortage. 

• Teva is the sole manufacturer of dextroamphetamine tablets. 



50

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 

20 mg single-dose vial, package of 10 (NDC 55390-0281-10) 








• Teva had daunorubicin on shortage due to manufacturing issues. 



Dacarbazine Injection 



Dacarbazine powder for injection, APP 

200 mg vial (NDC 63323-0128-20) 

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) 

200 mg vial, 10 count (NDC 00703-5075-03) 

Dacarbazine powder for injection, Bedford 

200 mg vial (NDC 55390-0090-10) 


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






• Hospira has dacarbazine on shortage due to manufacturing delays. 

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



51

Cytarabine Injection 



Cytarabine injection (powder for reconstitution), Bedford 

100 mg vial (NDC 55390-0131-10) 

500 mg vials (NDC 55390-0132-10) 

1 gram vials (NDC 55390-0133-01) 

100 mg (Novaplus) vial (NDC 55390-0806-10) 

500 mg (Novaplus) vials (NDC 55390-0807-10) 

1 gram (Novaplus) vials (NDC 55390-0808-01) 







• Bedford issued a voluntary recall of 3 lots of cytarabine 1 gram vials in February, 2012. The 

company determined there was a potential increased risk for lack of sterility with these specific 

lots. More information can be found online. 

• Bedford states the cytarabine shortage is due to manufacturing delays. Bedford discontinued 

cytarabine 2 gram presentations in May, 2011 to concentrate on the manufacturing of other 

products. 

• Hospira had found crystallization in some cytarabine 2 gram lots. The company is recommending 

to not use product that has crystallization. 

• APP recalled one lot of cytarabine in February, 2011 due to potential crystallization or 

precipitation in vials. 



Cyclosporine Injection 



Cyclosporine 50 mg/mL solution for injection, Bedford 


Cyclosporine 50 mg/mL solution for injection, Perrigo 




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

in late-November, 2011. 








52

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 51079-0218-20) - discontinued 

250 mg, 100 count unit dose (NDC 51079-0402-20) - discontinued 


Ciprofloxacin Immediate-Release Tablets, Watson 

500 mg, 100 count (NDC 16252-0515-01) 

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. 

• 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. 

53



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) 


• American Regent had temporarily suspended manufacture of most drug products in April, 2011. 


• APP had caffeine citrate on shortage due to increased demand. 







• Paddock could not provide a reason for the shortage. 

• Caraco states the shortage was due to increased demand for product. 



Tobramycin Injection 



Tobramycin Solution for Injection, Akorn 

40 mg/mL, 2 mL vial (NDC 23360-0014-02) - discontinued 


Tobramycin Solution for Injection, APP 


Tobramycin Solution for Injection, Hospira 




Tobramycin Solution for Injection, Teva 



Tobramycin Solution for Injection, Pfizer 




• Teva has tobramycin solution for injection on shortage due to manufacturing delays. 

• Hospira has tobramycin on shortage due to increased demand for the product. 

54

• APP had tobramycin 40 mg/mL presentation on shortage due to increased demand. 

• Pfizer acquired tobramycin injection from Akorn in early-May, 2011. 

• Pfizer states the reason for the shortage is manufacturing delay. 



Promethazine Injection 



Promethazine injection, West-Ward 

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

25 mg/mL 1 mL vial (NDC 00641-0928-25) 


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

25 mg/mL 1 mL Novaplus vial (NDC 00641-0955-25) 

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 



Promethazine injection, X-Gen 

25 mg/mL 1 mL ampule (NDC 39822-5500-03) 


• 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. 

• X-Gen could not provide a reason for the shortage. 



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, Hospira 


55


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. 



Mannitol Injection 



Mannitol injection, American Regent 

250 mg/mL, 50 mL vial, 25 count (NDC 00517-4050-25) 

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. 





Vitamin A Injection 



Aquasol A, Hospira 

50,000 units/mL, 1 mL ampule (NDC 61703-0418-07) 


• Hospira is changing manufacturing sites from a 3rd party manufacturer to in-house 

manufacturing. This has caused a delay in production. 

• Hospira is the sole manufacturer of vitamin A injection. 



Orphenadrine Citrate Injection 



Orphenadrine citrate injection, 30 mg/mL, Bedford 



• Watson stated the shortage was due to production delays. 

56








Labetalol Tablets 



Labetalol tablets, Sandoz 

100 mg, 100 count (NDC 00185-0010-01) 

200 mg, 500 count (NDC 00185-0117-05) 

Labetalol tablets, Teva 

100 mg, 500 count (NDC 00172-4364-70) 

200 mg, 100 count, unit dose (NDC 00172-4365-10) 

200 mg, 500 count (NDC 00172-4365-70) 

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. 



Aminophylline Injection 



Aminophylline injection, American Regent 



Aminophylline injection, Hospira 

25 mg/mL, 20 mL ampule (NDC 00409-7386-01) - discontinued 


• 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. 


57


Valsartan Tablets 



Diovan tablets, Novartis 

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


• Novartis is the sole supplier of valsartan tablets. 

• Novartis could not provide a reason for the shortage. 



Trazodone Tablets 



Trazodone tablets, Mylan 





Trazodone tablets, Qualitest 

100 mg, 500 count (NDC 00603-6161-28) 


• Apotex states the shortage was due to an import ban on this product that was only recently 

removed. Apotex relaunched trazodone tablets in September, 2011. 

• Mylan and Qualitest cannot provide a reason for the shortage. 



Pantoprazole Injection 



Protonix injection, Pfizer 

40 mg vial, package of 10 (NDC 00008-0923-55) 

40 mg vial, package of 25 (NDC 00008-0923-60) 

40 mg Novaplus vial, package of 10 (NDC 00008-0941-04) 


• Pfizer did not provide a reason for the shortage. 



Ketamine Injection 



Ketamine injection, Bedford 

50 mg/mL, 10 mL vial, package of 10 (NDC 55390-0475-10) 

Ketamine injection, Hospira 

58

50 mg/mL, 10 mL vial, package of 10 (NDC 00409-2053-10) 

Ketalar injection, JHP 

10 mg/mL, 20 mL vials (NDC 42023-0113-10) 


• JHP has Ketalar on shortage due to increased demand. 

• Mylan Institutional states the reason for the shortage is increased demand. 

• Hospira has ketamine on shortage due to manufacturing delays. 








Amphetamine Mixed Salts, Immediate-Release Tablets 



Amphetamine mixed salts immediate-release tablets, Teva 


7.5 mg tablets, 100 count (NDC 00555-0775-02) 






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. 

59



Amphetamine Mixed Salts, Extended-Release Capsules 



Amphetamine mixed salts extended-release capsules, Teva 







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. 



Methotrexate Injection 



Methotrexate 25 mg/mL (with preservative), APP1 

10 mL (with preservative) vial (NDC 63323-0123-10) 

2 mL vial (NDC 63323-0123-02) – discontinued 

Methotrexate 25 mg/mL injection, Bedford2 

2 mL vial, preservative-free (NDC 55390-0031-10) 




Methotrexate lyophilized powder for injection, Bedford2 

1 gram vial (NDC 55390-0143-01) 

Methotrexate 25 mg/mL injection, Hospira3 

2 mL (with preservative) vial (NDC 61703-0350-38) 

40 mL preservative-free vial (NDC 61703-0408-41) 

Methotrexate 25 mg/mL injection, Mylan Institutional4 



40 mL preservative-free vial (NDC 10139-0062-40) 

Methotrexate 25 mg/mL injection, Sandoz5 

60





• 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. 






• 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. 

• Mylan Institutional (formerly Bioniche) cannot provide a reason for the shortage. 

• Bioniche was acquired by Mylan Institutional in September, 2011. 



Azathioprine Injection 



Azathioprine injection, lyophilized powder, Bedford 

100 mg vial (NDC 55390-0600-20) 








• There are no other manufacturers of azathioprine injection. 

• The oral presentations are not affected by this shortage. 



Protamine Sulfate 



Protamine Sulfate 10 mg/mL, American Pharmaceutical Partners (APP) 

5 mL vials (NDC 63323-0229-05) 

5 mL Novaplus vials (NDC 63323-0229-15) 

25 mL vials (NDC 63323-0229-30) 

25 mL Novaplus vials (NDC 63323-0229-35) 


APP has protamine on shortage due to increased demand. 

There are no other manufacturers of protamine sulfate. 

61



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 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. 



Norepinephrine Injection 



Norepinephrine, 1 mg/mL, Bedford 

4 mL vial, package of 10 (NDC 55390-0002-10) 

Norepinephrine, 1 mg/mL, Teva 

4 mL vial, package of 10 (NDC 00703-1153-03) - temporarily discontinued 







• Teva temporarily discontinued norepinephrine in June 2010. 

• Hospira had Levophed on shortage due to increased demand for the product. Hospira has 

increased production of Levophed to meet this demand. 



Mitomycin Injection 



Mitomycin Powder for Injection (Mannitol Formulation), Bedford 

62

5 mg single dose vial, package of 1 (NDC 55390-0251-01) 



5 mg Novaplus single dose vial, package of 1 (NDC 55390-0451-01) 



Mitomycin Powder for Injection (Mannitol Formulation), Accord 

5 mg single dose vial (NDC 16729-0115-05) 

20 mg single dose vial (NDC 16729-0108-11) 







• Accord states the reason for the shortage is increased demand. 



Epinephrine Injection 



Epinephrine injection, 1 mg/mL, American Regent 

1 mL ampule, sulfite-free, package of 25 (NDC 00517-1071-25) 






Bupivacaine with epinephrine injection 



Bupivacaine 0.25% with epinephrine 

Bupivacaine 0.25% with epinephrine 1:200,000 injection, Hospira 


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 

63




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. 



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 




50 mL vial, multi-dose (NDC 00409- 1163-01) 

64

20 mL glass ampule, sterile pack (NDC 00409-4273-01) 

Marcaine 0.5%, Hospira 










Bupivacaine 0.75%, Hospira 



Marcaine 0.75%, Hospira 







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

• Hospira has bupivacaine and Marcaine on shortage due to manufacturing delays. 



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) 






• Akorn cannot provide a reason for the shortage. 



Ropivacaine Injection 



Naropin Injection, 2 mg/mL, APP 

10 mL ampule, sterile pack (NDC 63323-0285-10) 

65


100 mL infusion bottle (NDC 63323-0285-65) 

100 mL Novaplus infusion bottle (NDC 63323-0285-67) 




30 mL sterile pack single dose vial (NDC 63323-0286-31) 

30 mL vial (NDC 63323-0286-30) 




Naropin Injection, 7.5 mg/mL, APP 





20 mL Novaplus ampule, sterile pack (NDC 63323-0288-27) 


• APP states the reason for the shortage is due to increased demand due to shortage in other 

anesthetic drugs. 



Ondansetron Injection 



Ondansetron 2 mg/mL vials 

Ondansetron injection, 2 mg/mL, APP 

2 mL vials, package of 25 (NDC 63323-0373-02) 

20 mL multiple dose vials (NDC 63323-0374-20) 

Ondansetron injection, 2 mg/mL, Apotex 

2 mL vials, package of 5 (NDC 60505-0744-01) - discontinued 

20 mL multiple dose vial (NDC 60505-0744-06) - discontinued 

Ondansetron injection, 2 mg/mL, Baxter 

1 mL vials (NDC 10019-0905-17) - discontinued 

Ondansetron injection, 2 mg/mL, Bedford 

20 mL vial (NDC 55390-0121-01) 

2 mL vials, packages of 10 (NDC 55390-0121-10) - discontinued 

2 mL Novaplus vials, packages of 10 (NDC 55390-0307-10) - discontinued 

20 mL Novaplus vials, packages of 1 (NDC 55390-0307-01) - discontinued 

Ondansetron injection, 2 mg/mL, Caraco 

2 mL ampules (NDC 62756-0181-01) - discontinued 


Ondansetron injection, 2 mg/mL, Cura 


Ondansetron injection, 2 mg/mL, Hospira 

2 mL iSecure syringe (NDC 00409-1120-62) - NDC discontinued 

66

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 (formerly Baxter products) 



2 mL Novaplus vials, packages of 25 (NDC 00641-6080-25) 

20 mL vials (NDC 00641-6079-01) 

Ondansetron injection, 2 mg/mL, West-Ward 


20 mL vials (NDC 00143-9890-01) 

Ondansetron injection, 2 mg/mL, Teva 



20 mL vials (NDC 00703-7226-01) 


Ondansetron injection, 2 mg\mL, Wockhardt 


20 mL vials (NDC 64679-0727-01) 

Zofran injection, 2 mg/mL, GlaxoSmithKline 


Ondansetron 32 mg/50 mL premixed bags 

Ondansetron injection, premixed bags, Claris 

32 mg/50 mL (NDC 36000-0014-06) 

Ondansetron injection, premixed bags, Pfizer 

32 mg/50 mL (NDC 00069-0700-12) - discontinued 

Ondansetron injection, premixed bags, Sagent 


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) 

Ondansetron injection, premixed bags, West-Ward 



Ondansetron 2 mg/mL vials 

• 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. 

• Bedford discontinued ondansetron 2 mg/mL 2 mL vials in May, 2011 to concentrate on the 

manufacturing of other products. 



67




• GlaxoSmithKline have discontinued Zofran 2 mL vials. 

• Hospira has ondansetron on shortage due to quality improvement issues. 

Ondansetron 32 mg/50 mL premixed bags 

• 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. 



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) 




40 mg/mL, 100 mL vials premixed bag (NDC 00409-6729-23) 

40 mg/mL, 500 mL vials premixed bag (NDC 00409-6729-03) 





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. 



Lidocaine Injection 



68

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 1% 

Lidocaine 1% injection, APP 



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) 




Lidocaine 1% injection, Hospira 

10 mg/mL, 30 mL preservative-free vial (NDC 00409-4279-02) 



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 

15 mg/mL, 10 mL ampule (NDC 63323-0493-97) 


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, APP 


20 mg/mL, 5 mL SD Tear Top vial, preservative-free (NDC 63323-0208-05) 





20 mg/mL, 10 mL vial (NDC 63323-0486-10) – NDC discontinued 



69

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) 




20 mg/mL, 5 mL Ansyr plastic emergency syringes (NDC 00409-1323-05) 

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. 



Ciprofloxacin Injection 



Ciprofloxacin injection, Claris 



Ciprofloxacin injection, Hospira 



Ciprofloxacin injection, Sagent 


Ciprofloxacin injection, Teva 

2 mg/mL, 100 mL premixed bag (NDC 00703-0969-36) - discontinued 




Cipro injection, Merck 






• Claris has recalled all lots of their ciprofloxacin premixed bags. More information can be found 

online. 

• Pfizer discontinued ciprofloxacin injection in 2010. 

70

• Teva discontinued all ciprofloxacin injection in September, 2011. 

• Bedford discontinued ciprofloxacin injection in May, 2011 to concentrate on the manufacturing 

of other products. 

• Bayer took over Cipro IV from Merck in 2011. 

• Hospira has ciprofloxacin vials on shortage due to manufacturing delays. 



Sodium Bicarbonate Injection 


Products Affected - Descriptio 

Sodium Bicarbonate Injection 8.4%, Amphastar (IMS) 

50 mL syringe, 10 count (NDC 00548-3352-00) 

50 mL Min-I-Jet (NDC 00548-1052-00) - discontinued 

50 mL Stick-Gard (NDC 00548-2052-00) - discontinued 

Sodium Bicarbonate Injection 8.4%, American Regent 


Sodium Bicarbonate Injection 7.5%, American Regent 


Sodium Bicarbonate Injection 4.2%, APP 

5 mL vial (NDC 63323-0026-05) 

Sodium Bicarbonate Injection 4.2%, 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. 



Sodium Acetate Injection 



Sodium acetate, American Regent 

2 mEq/mL, 20 mL vial (NDC 00517-2096-25) 


Sodium acetate, APP 

71


Sodium acetate, Hospira 





• American Regent had temporarily suspended distribution of most drug products including 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. 



Phytonadione (Vitamin K) Injection 



Vitamin K injection, contains benzyl alcohol, Hospira1,2 

1 mg/0.5 mL ampule (NDC 00409-9157-01) 


Vitamin K injection, contains polysorbate 80 and propylene glycol, Amphastar3-5 

1 mg/0.5 mL, SAF-T-JET prefilled syringe (NDC 00548-1240-00) 

1 mg/0.5 mL, MINIJET prefilled syringe (NDC 00548-1140-00) 


• 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. 



Papaverine Injection 



Papaverine injection 


• Bedford and Sandoz have discontinued their papaverine presentations. 

• American Regent, the sole supplier of papaverine injection, had temporarily suspended 

distribution of all drug products in April, 2011. 




Nicardipine Hydrochloride Injection 



Nicardipine hydrochloride injection, Teva 

2.5 mg/mL, 10 mL vials (NDC 00703-8315-03) - discontinued 

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Nicardipine hydrochloride injection, American Regent 

2.5 mg/mL, 10 mL vials (NDC 40042-0047-10) 


• Teva recalled 4 lots nicardipine injection because the product did not meet purity specifications. 

The recalled lots are 31302508B, 31302510B, 31302957B, 31303195B. 

• Teva discontinued nicardipine injection in September, 2010. 

• American Regent had temporarily suspended distribution of all drug products in April, 2011. 

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



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) 

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. 



Metoclopramide Injection 



Metoclopramide injection, Hospira 

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. 

Article Link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=611 


Diphenhydramine Hydrochloride for Injection 



Diphenhydramine injection, 50 mg/mL, Hospira 


Diphenhydramine injection, 50 mg/mL, Mylan Institutional 

10 mL vial (NDC 67457-0124-10) 

73


• Mylan Institutional has diphenhydramine injection on shortage due to increased demand. The 

company is increasing production to try to meet this demand. 

• 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. 



Dextrose Injection 50% 



Dextrose Injection 50%, Hospira 



• Hospira states the shortage is due to manufacturing delays. 



Desmopressin Injection 



Desmopressin injection, 4 mcg/mL, Ferring 

1 mL vial (NDC 55566-5030-01) 

10 mL multi-dose vial (NDC 55566-5040-01) 

Desmopressin injection, 4 mcg/mL, Hospira 

1 mL vial (NDC 00409-2265-01) 

Desmopressin injection, 4 mcg/mL, Teva 

1 mL vial (NDC 00703-5051-03) 

10 mL multi-dose vial (NDC 00703-5054-01) 

DDAVP, 4 mcg/mL, Sanofi 

1 mL vial (NDC 00075-2451-01) 

10 mL vial (NDC 00075-2451-53) 


• Ferring cannot provide a reason for the shortage. 

• Teva and Hospira have desmopressin injection on shortage due to manufacturing delays. 



Ammonium Chloride Injection 



Ammonium chloride injection, Hospira 



• Hospira states the shortage of ammonium chloride is due to manufacturing delays. 

• Hospira is the sole manufacturer of ammonium chloride injection. 

74



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 vial (NDC 00409-1778-05) 

Metoprolol 1 mg/mL Injection, Sagent 

5 mL vial (NDC 25021-0303-05) 


• American Regent had temporarily suspended manufacture of most drug products 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. 





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

select “Customer supply update report”. 

• Sagent has metoprolol injection on shortage due to increased demand for the product. 



Methazolamide Tablets 



Methazolamide Tablets, Fera 



Methazolamide Tablets, Sandoz 




• Fera cannot provide a reason for the shortage. 

• Sandoz cannot provide a reason for the shortage. 



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Metformin Oral Tablets 



Metformin tablets, Amneal 

500 mg extended release, 90 count (NDC 53746-0178-90) - discontinued 

Metformin tablets, Glenmark 

500 mg, 100 count (NDC 68462-0159-01) 

500 mg, 1000 count (NDC 68462-0159-10) 

850 mg, 90 count (NDC 68462-0160-90) 

850 mg, 100 count (NDC 68462-0160-01) 

1000 mg, 90 count (NDC 68462-0161-90) 

1000 mg, 1000 count (NDC 68462-0161-10) 

Metformin tablets, Mutual Pharmaceuticals 










Metformin tablets, Mylan 

500 mg, 100 count (NDC 00378-0234-01) 

850 mg, 100 count (NDC 00378-0240-01) 

750 mg extended release, 100 count (NDC 00378-0350-01) 




Metformin tablets, Ranbaxy 




Metformin tablets, Sandoz 

850 mg, 12 x 60 package (NDC 00781-5051-61) 

Metformin tablets, Teva 




Metformin tablets, UDL 

850 mg, 100 count, unit-dose (NDC 51079-0973-20) - discontinued 




Metformin tablets, Watson 


1000 mg, 1000 count (NDC 62037-0676-10) – discontinued 


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• Apotex had metformin products unavailable due to an FDA import ban. Metformin immediaterelease 

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. 

• 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. 



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 10019-0102-01) 

10 mL vial (NDC 10019-0102-10) 


10 mL Novaplus vial (NDC 10019-0105-02 ) 

Ativan 2 mg/mL, West-Ward 

1 mL vial (NDC 60977-0112-01) 

10 mL vial (NDC 60977-0116-02) 

Lorazepam 4 mg/mL, West-Ward 

1 mL vial (NDC 10019-0103-01) 


10 mL vial (NDC 10019-0103-10) 


Ativan 4 mg/mL, West-Ward 

1 mL vial (NDC 60977-0113-01) 

10 mL vial (NDC 60977-0113-02) 


77

• 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. 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. 



Echothiophate Powder for Ophthalmic Solution 



Phospholine Iodide 0.125%, Pfizer 

5 mL bottle (NDC 00046-1065-05) 


• Pfizer (formerly Wyeth) states Phospholine Iodide is in short supply due to a raw material 

shortage. 



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) 



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 was not able to provide a reason for the shortage. 

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• Covis purchased all rights to Fortaz from GlaxoSmithKline. 



Calcium Acetate Capsules 



Calcium acetate capsules, Roxane 


PhosLo capsules, Fresenius 



• Roxane and Fresenius cannot provide a reason for the shortage. 



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April 2012 Drug Information Update - Pharmacy Benefits ...

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