February 2010 Drug Information Update - Pharmacy Benefits ...

February 2010 

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 4-6 

Page 6-8 

Page 8-13 

Page 13-17 

Page 17-42 

Page 42-62 

2

First-Time Generics 

GENERIC DRUG NAME 

IRON FUM & P/FA/VIT B 

& C NO. 

IRON FUM & PS CMP/ 

FA/VIT C/B3 

PNV NO.15/IRON FUM 

& PS CMP/F 

PNV48/IRON NA 

FEREDETAT/FA/OM 

PNV WITH CA,NO.60/ 

IRON/FA/DHA 

PNV39/IRON 

FUMARATE/FA/DSS/DH 

OXCARBAZEPINE 

BUDESONIDE 

NIZATIDINE 

BROMPHENIRAMINE 

MALEATE 

EPINEPHRINE 

COSYNTROPIN 

BROMPHENIRAMIN/PE/ 

DEXTROMETHO 

SOD FERRIC GLUC 

COMPLX/SUCROSE 

PRAMIPEXOLE DI-HCL 

DIPHENHYDRAMIN/PE/ 

CODEINE PHOSPHATE 

BROMPHENIRAMIN/PE/ 

CODEINE PHOSPHATE 

BENZOYL PEROXIDE 

GENERIC 

MANUFACTURER 

TRIGEN 

TRIGEN 

TRIGEN 

TRIGEN 

TRIGEN 

TRIGEN 

SANDOZ 

TEVA 

AFFORDABLE 

POLY 

SCIELE 

GENERAMEDIX 

TRIGEN 

SANOFI-AVENTIS 

TEVA 

BRAND NAME 

INTEGRA PLUS 

CAPSULE 

INTEGRA F 

CAPSULE 

CONCEPT OB 

CAPSULE 

DUET DHA 

FERRAZONE EC 

OMEGA-3 

GESTICARE DHA 

DR COMBO PACK 

PRENEXA 

CAPSULE 

TRILEPTAL 300 

MG/5 ML SUSP 

PULMICORT 0.25 

MG/2 ML AND 0.5 

MG/2 ML RESPULE 

AXID 15 MG/ML 

ORAL SOLUTION 

RESPA-BR 

TABLET SA 

EPIPEN 0.3 MG 

AUTO-INJECTOR 

CORTROSYN 0.25 MG 

VIAL 

ALA-HIST DM 

LIQUID 

FERRLECIT 62.5 

MG/5 ML AMPUL 

MIRAPEX 0.125MG, 

0.25MG,0.5MG,1 

MG,1.5MG 

TABLET 

APPROVAL 

DATE 

12/16/09 

12/16/09 

12/16/09 

12/16/09 

12/16/09 

12/16/09 

12/16/09 

3/27/09 

12/21/09 

12/15/09 

12/16/09 

12/26/09 

1/14/10 

12/21/09 

1/5/10 

CENTURION ENDAL CD SYRUP 1/13/10 

TRIGEN 

PERRIGO 

POLY-TUSSIN AC 

LIQUID 

BENZAC W WASH 5% 

LIQUID 

1/14/10 

6/5/08 

ANALPRAM E 2.5% 

HYDROCORT/PRAMOXN/EMOL/ PRAM ACELLA 

1/26/10 

CREAM KIT 

Gruenhaupt, Mark R.Ph. Argus Health Systems, Inc. c2005 Available from: www.argushealth.com [cited January 7, 2010]. 


Gruenhaupt, Mark R.Ph. Argus Health Systems, Inc. c2005 Available from: www.argushealth.com [cited February 4, 2010]. 

U.S. Food and Drug Administration. Generic Drug Approvals. Available from: http://www.fda.gov/cder/ogd/approvals/ 

default.htm [updated February 9, 2010]. 

3

New Drug Entities 

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES 

GASTROINTESTINAL 

RADIOPAQUE 

DIAGNOSTICS 

TX FOR ATTENTION 

DEFICIT- HYPERACT 

(ADHD)/NARCOLEPSY 

ANAPHYLAXIS 

THERAPY AGENTS 

ANTI-PSYCHOTICS, 

ATYPICAL, 

DOPAMINE,& 

SEROTONIN ANTAG 

NARCOTIC 

ANTITUSSDECONGEST 

ANTEXPECTORANT 

COMB 

NARCOTIC 

ANTITUSS-1ST GEN. 

ANTIHISTAMINE 

DECONGEST 

NARCOTIC 

ANTITUSSDECONGEST 

ANTEXPECTORANT 

COMB 

NARCOTIC 

ANTITUSS-1ST GEN. 

ANTIHISTAMINE 

DECONGEST 

BETA- ADRENERGIC 

BLOCKING AGENTS 

ANTIMIGRAINE 

PREPARATIONS 

CITRATES AS 

ANTICOAGULANTS 

ANALGESICS, 

NARCOTICS 

ANALGESICS, 

NARCOTICS 

ANALGESICS, 

NARCOTICS 

BILE SALT 

SEQUESTRANTS 


RADIOPAQUE 

DIAGNOSTICS 

FOCALIN XR CPMP 

50-50 

ADRENACLICK PEN 

INJCTR 

FANAPT TABLET 

LORTUSS EX LIQUID 

POLY HIST NC 

LIQUID 

POLY-TUSSIN EX 

LIQUID 

POLY HIST DHC 

LIQUID 

SOTALOL HCL IV 

VIAL 

SUMAVEL DOSEPRO 

NDL FR INJ 

SODIUM CITRATE 

DISP SYR 

MORPHINE 

SULFATENS 

PCA SYR 

HYDRO-MORPHONE 

HCL-NS PCA SYR 

MEPERIDINE HCLNS 

PCA SYR 

WELCHOL POWD 

PACK 

BARIUM 

SULFATE 

DEXMETHYLPHENIDAT 

E 

HCL 

100% (W/V) 

30 MG 

EPINEPHRINE 0.15/0.15 

ILOPERIDONE 

P-EPHED HCL/CODEINE/ 

GUAIFEN 

P-EPHED HCL/CODEINE/ 

TRIPROL 

PHENYLEPH/ 

DIHYDROCODEINE/ 

GUAIF 

POLY HIST DHC 

LIQUID 

SOTALOL HCL 

SUMATRIPTAN 

SUCCINATE 

SODIUM 

CITRATE 

DISP SYR 

MORPHINE 

SULFATE/ NS/ 

PF 

HYDROMORPHONE 

HCL/NS/PF 

MEPERIDINE 

HCL/NORMAL 

SALINE 

COLESEVELAM 

HCL 

1MG,2MG,4MG,6 

MG,8MG,10MG,1 

2MG,1-2-4-6MG 

22.5-10/ 5 

15-10-1.25 

5-7.5-50/ 5 

7.5-5-7.5 

150MG/ 

10ML 

6MG/ 0.5ML 

4 % (3 ML) 

25MG/ 

25ML 

5MG/ 25ML 

250MG/ 

25ML 

3.75 G 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW 

ENTITY 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW ROUTE 

AND 

DOSAGE FORM 

NEW DOSAGE 

FORM 

NEW 

STRENGTH/ 

DOSAGE FORM 

NEW 

DILUTION 

NEW 

DILUTION 

NEW 

DILUTION 

NEW 

STRENGTH/ 

DOSAGE FORM 

4


KERATOLYTICS 

INFLUENZA VIRUS 

VACCINES 

ENDAL CD LIQUID 

NEUROMUSCULAR 

BLOCKING 

AGENTS 

PRENATAL 

VITAMIN 

PREPARATIONS 

1ST GEN 

ANTIHISTAMINE & 

DECONGESTANT 

COMBINATIONS 


RADIOPAQUE 

DIAGNOSTICS 

PLASMA 

KALLIKREIN 

INHIBITORS 

URINARY PH 

MODIFIERS 

PRENATAL 

VITAMIN 

PREPARATIONS 

PRENATAL 

VITAMIN 

PREPARATIONS 

PRENATAL 

VITAMIN 

PREPARATIONS 

1ST GEN 

ANTIHISTAMINE 

DECONGESTANT 

COMBINATIONS 

NON-NARC 

ANTITUSS-1 ST GEN. 

ANTIHISTAMINE 

DECONGESTANT 

VAGINAL 

ESTROGEN 

PREPARATIONS 

ANTIPSORIATIC 

AGENTS, 

SYSTEMIC 

INTER-LEUKIN-6 (IL-6) 

RECEPTOR INHIBITORS 

PACNEX MX 

CLEANSER 

FLUZONE HIGHDOSE 

DISP SYR 

ENDAL CD LIQUID 

BOTOX 

INJECTION 

PREQUE 10 

TABLET 

RESCON-JR. 

TAB.SR 12H 

E-Z DISK 

TABLET 

KALBITOR 

SUB-Q VIAL 

UROCIT-K 

TABLET SA 

CITRANATAL 

90 DHA 

COMBO.PKG 

CITRANATAL 

B-CALM 

TABLET SEQ 

MARNATALF 

CAPSULE 

ACCUHIST 

DROPS 

ACCUHIST 

PDX DROPS 

VAGIFEM 

VAGINAL 

TAB 

SORIATANE 

CAPSULE 

ACTEMRA VIAL 

BENZOYL 

PEROXIDE 

INFLUENZA 

TVS 09-10 

VACCINE/PF 

DIPHENHYDRAMIN/ 

PE/CODEINE 

PHOS 

ONABOTULINUMTOXIN 

A 

PREQUE 10 

TABLET 

DEXCHLORPHENIR/ 

PHENYLEPHRINE 

BARIUM 

SULFATE 

ECALLANTIDE 

POTASSIUM 

CITRATE 

PN W-CA64/ 

IRON CB&GL/ 

FA/ DSS/DH 

PNV WITH 

CA, NO63/ 

IRON/FA/B6 

PNV WITH CA 

NO.65/ IRON 

POLY/FA 

PHENYLEPHRINE 

HCL/ CHLORMAL 

DMETHORPHAN 

HB/PE/ 

CHLORPHENIR 

ESTRADIOL 

ACITRETIN 

TOCILIZUMAB 

4.25% 

180MCG/ 

0.5ML 

10-7.5-7.5 

200 UNIT 

15-0.5-50 

3 MG-20 

MG 

700 MG 

10MG/ ML 

(1) 

15 MEQ 

90-1- 

300MG 

20-1-25 MG 

60 MG-1 

MG 

2.5-1MG/ML 

2.5-1MG/ML 

10 MCG 

17.5MG,22.5MG 

80 MG/4 ML, 200 

MG/10 ML, 400 

NEW 

STRENGTH/ 

DOSAGE FORM 

NEW 

STRENGTH/ 

DOSAGE FORM 

NEW 

STRENGTH/ 

DOSAGE FORM 

NEW 

STRENGTH 

NEW 

COMBINATION 

NEW 

STRENGTH 

NEW 

STRENGTH/ 

DOSAGE FORM 

NEW 

ENTITY 

NEW 

STRENGTH 

NEW 

COMBINATION 

NEW 

COMBINATION 

NEW 

COMBINATION 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW 

STRENGTH 

NEW ENTITY 

5


GLUCOCORTICOIDS 

ANTIFUNGAL AGENTS 

ANTIVIRALS, GENERAL 

ANTIHYPERGLY, 

INCRETIN 

MIMETIC(GLP-1 

RECEP.AGONIST) 

TOXIN- PRODUCING 

BACILLI VACCINES/ 

TOXOIDS 

MONOCLONAL 

ANTIBODY-HUMAN 

INTERLEUKIN 12/23 

INHIB 

SOLU-MEDROL VIAL 

FLUCONAZOLE IN 

SALINE PGGBK 

VALCYTE SUSP 

RECON 

VICTOZA PEN INJCTR 

METHYL- 

PREDNISOLONE SOD 

SUCC/PF 

FLUCONAZOLE IN 

SALINE, ISO-OSM 

VALGANCICLOVIR 

HYDROCHLORIDE 

LIRAGLUTIDE 

MG/20 ML 

40 MG/ML, 

125MG/2 ML, 

500MG/4 ML, 

1000 MG/8 ML 

100MG/ 50ML 

50 MG/ ML 

0.6MG/ 0.1ML 

PRESERVATIVE 

FREE 

NEW DILUTION 

NEW DOSAGE 

FORM 

NEW ENTITY 

BIOTHRAX VIAL ANTHRAX VACCINE 0.5ML/ DOSE NEW VACCINE 

STELARA DISP SYRIN USTEKINUMAB 45MG/ 0.5ML, 90 

MG/ML 

NEW DOSAGE 

FORM 



Gruenhaupt, Mark R.Ph. Argus Health Systems, Inc. c2005 Available from: www.argushealth.com [cited February 4, 2010]. 

New Indications (Existing Drugs) 

Azilect® 

December 14, 2009 - Teva Pharmaceutical Industries, Ltd. today announced the U.S. Food and 

Drug Administration (FDA) approved the newly revised prescribing information for Azilect 

(rasagiline tablets) reducing medication and food restrictions. This update was based on clinical 

data that confirmed the mechanism of action of Azilect as a selective MAO-B (monoamine 

oxidase-B) inhibitor at the recommended doses of 1 mg and 0.5 mg. The newly approved 

prescribing information reflects reduced concerns regarding the use of Azilect together with 

certain medications, including many over-the-counter cough/cold medications. In addition, 

patients taking Azilect no longer need to follow a general dietary restriction of ordinary levels of 

tyramine, an amino acid found in certain foods and beverages, such as air-dried and fermented 

meats, aged cheeses and most soybean products. However, due to potential mild increased 

sensitivity in some patients, ingestion of very high levels of tyramine (e.g., >150 mg) should be 

avoided by patients taking MAO inhibitors. 

Article link: http://www.drugs.com/newdrugs/fda-approves-newly-revised-azilect-reducingfood-restrictions-1830.html 

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

Fluzone High-Dose® 

December 23, 2009 - The U.S. Food and Drug Administration today approved Fluzone High- 

Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent 

6

disease caused by influenza virus subtypes A and B. People in this age group are at highest risk 

for seasonal influenza complications, which may result in hospitalization and death. Annual 

vaccination remains the best protection from influenza, particularly for people 65 and older. 

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated 

approval pathway helps safe and effective medical products for serious or life-threatening 

diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an 

enhanced immune response compared with Fluzone in individuals 65 and older. 

Article link: http://www.drugs.com/newdrugs/fda-approves-newly-revised-azilect-reducingfood-restrictions-1854.html 


Velcade ® 

January 4, 2010 - Millennium: The Takeda Oncology Company today announced that the U.S. 

Food and Drug Administration (FDA) has approved a supplemental new drug application 

(sNDA) for Velcade, which expands the label to include long-term (median follow-up 36.7 

months) overall survival (OS) data from the landmark VISTA1 trial and provides specific dosing 

recommendations for patients with hepatic impairment. The VISTA trial examined the use of 

Velcade based therapy in patients with previously untreated multiple myeloma (MM). 

Article link: http://www.drugs.com/newdrugs/fda-approves-seasonal-influenza-vaccinespecifically-intended-ages-65-older-1854.html 


Atripla ® 

January 7, 2010- FDA approved an updated Atripla label including new efficacy, safety and 

resistance data in treatment experienced patients from a trial (Study 073: A Phase IV, Open- 

Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of single Tablet 

Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 

Infected Subjects Who Have Achieved Virological Suppression on their HAART Regimen) in 

which HIV-1 infected adults on a stable antiretroviral regimen were either switched to Atripla or 

remained on their background regimen to compare the effectiveness (efficacy, safety, and 

tolerability)of Atripla to that of subjects continuing unmodified HAART as measured by the 

proportion of subjects who maintain HIV-1 RNA

January 29, 2010 - GlaxoSmithKline announced today that the U.S. Food and Drug 

Administration (FDA) has granted accelerated approval for a new combination regimen using 

Tykerb® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer. 

Tykerb is now indicated in combination with letrozole for the treatment of postmenopausal 

women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 

receptor for whom hormonal therapy is indicated. Tykerb in combination with an aromatase 

inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the 

treatment of metastatic breast cancer. 

Article link: http://www.gsk.com/media/pressreleases /2010/2010_pressrelease_10012.htm 

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

FDA News/Bulletins/Advisories/Safety Alerts 

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots 

[Posted 12/28/2009] McNeil Consumer Healthcare and FDA notified consumers that it is 

expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain 

Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers 

provided in press release at link below). In November 2009, 5 lots of this product were recalled 

due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated 

with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a 

chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden 

pallets that transport and store packaging materials. The health effects of this compound have not 

been well studied, and to date all of the observed events reported to McNeil were temporary and 

non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with 

the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the 

product and contact McNeil for instructions on a refund or replacement. 

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

SafetyAlertsforHumanMedicalProducts/ucm195704.htm 

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

Nzu, Traditional Remedy for Morning Sickness 

[Posted 12/31/2009] The Texas Department of State Health Services and FDA notified 

healthcare professionals and consumers, especially pregnant or breastfeeding women, to avoid 

consuming a product called “Nzu”, taken as a traditional remedy for morning sickness, because 

of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by 

Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child 

is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and 

excessive long-term exposure to it has been associated with a range of adverse health effects, 

including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty 

stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally 

resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label 

identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should 

contact their health care provider. Any adverse events that may be related to use should be 

reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program 

online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the 

8

postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download 

Forms" page] by mail [to address on the preaddressed form] or fax [1-800-FDA-0178]. 

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

SafetyAlertsforHumanMedicalProducts/ucm196045.htm 


Cleviprex (clevidipine butyrate): Recall 

[Posted 12/17/2009] The Medicines Company and FDA notified healthcare professionals of a 

nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated 

for treatment of hypertension, due to the potential presence of particulate matter found to be inert 

stainless steel particles. If the particles were to aggregate, or if larger particles were present, then 

they could theoretically reduce blood flow in capillaries, cause mechanical damage to some 

tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may 

lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs. 

Article link: 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProduct 

s/ucm194585.htm 


Rapamune (sirolimus): Drug Monitoring Recommendations 

[Posted 01/11/2010] Wyeth notified healthcare professionals of changes to the Rapamune 

Prescribing Information regarding changes in the performance of an immunoassay used for 

therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are 

both assay and laboratory-dependent. In addition, the results may change over time. Therefore, 

adjustment to the targeted therapeutic range must be made with a detailed knowledge of the sitespecific 

assay used. Sirolimus whole blood concentrations can be measured by either 

chromatographic or immunoassay methodologies. These two methodologies are not directly 

interchangeable and the measured sirolimus whole blood concentrations depend on the type of 

assay used. As such, if different assays are used in monitoring a single patient, the dose of 

Rapamune might be adjusted improperly with potential consequences, such as allograft rejection 

if drug exposure is too low or toxic side effects if exposure is too high. Wyeth has advised 

healthcare providers involved in the management of patients taking Rapamune to determine: 1) 

which assay is being used in their laboratory(ies); 2) if there is any change to the assay used; 3) if 

there is a change to the laboratory’s reference range and/or a subsequent change to the 

institution’s or referring center’s recommended range for sirolimus. With this information, target 

levels can be appropriately adjusted in order to achieve optimal clinical results. 

It is critical that the clinician caring for a patient on sirolimus maintain communication with their 

laboratory to determine whether the assay used for measuring sirolimus concentrations has been 

changed. 

Article link: 




Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an 

Ongoing Safety Review 

[Posted 01/21/2010] FDA notified healthcare professionals that the review of additional data 

indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular 

disease using sibutramine. Based on the serious nature of the review findings, FDA requested 

9

and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating 

that sibutramine is not to be used in patients with a history of cardiovascular disease, including: 

History of coronary artery disease (e.g., heart attack, angina) 

History of stroke or transient ischemic attack (TIA) 

History of heart arrhythmias 

History of congestive heart failure 

History of peripheral arterial disease 

Uncontrolled hypertension (e.g., > 145/90 mmHg) 

Patients currently using sibutramine should talk with their healthcare professional to determine if 

continued use of sibutramine is appropriate and discuss any questions they may have about their 

treatment. 

Article link: 




McNeil Consumer Healthcare Over-The-Counter Products: Recall 

[Posted 01/15/2010] McNeil and FDA notified healthcare professionals of an expansion of the 

December 2009 recall. McNeil Consumer Healthcare has now applied broader criteria to identify 

and remove all product lots that it believes may have the potential to be affected, even if they 

have not been the subject of consumer complaints. Consumers who purchased product from the 

lots included in this recall should stop using the product and contact McNeil Consumer 

Healthcare for instructions on a refund or replacement. The affected product names and lot 

numbers for the recalled products can be found in firm's Press Release. Any adverse reactions 

may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at 

MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website 

at www.fda.gov/medwatch. 

Article link: 




Alli 60 mg capsules (120 count refill kit): Counterfeit Product 

[Posted 01/18/2010] FDA notified consumers and healthcare professionals about a counterfeit 

and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit 

version contained the controlled substance sibutramine and did not contain orlistat, the active 

ingredient. Sibutramine is a drug that should not be used in certain patient populations or without 

physician oversight. Sibutramine can also interact in a harmful way with other medications the 

consumer may be taking. GSK has determined that the counterfeit product has been sold over the 

internet. However, there is no evidence at this time that the counterfeit Alli product has been sold 

through other channels, such as retail stores. The differences between the counterfeit and 

authentic products are described in both text and photos in the FDA news release. 

Article link: 




FDA Approves Dalfampridine to Improve Walking in Adults with Multiple Sclerosis 

10

[Posted January 25] - The U.S. Food and Drug Administration today approved Ampyra 

(dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis 

(MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated 

with an inactive pill (placebo). This is the first drug approved for this use. MS is a chronic, often 

disabling, disease that affects the central nervous system—the brain, spinal cord, and optic 

nerves. There are about 400,000 people in the United States and 2.5 million people world-wide 

with MS. The progress, severity, and specific symptoms of MS are unpredictable and vary from 

one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as 

paralysis or loss of vision. About half of all people with MS experience cognitive impairments 

like difficulties in concentration, attention, memory, and judgment, although these symptoms are 

usually mild and are frequently overlooked. Depression also is common among MS patients. 

“Trouble with walking is one of the most debilitating problems people with MS face,” said 

Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug 

Evaluation and Research. Ampyra, when given at doses greater than that recommended (10 

milligrams twice a day), can cause seizures. The most common adverse reactions reported by 

patients taking Ampyra in clinical trials include urinary tract infection, insomnia, dizziness, 

headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, 

constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin. 

Ampyra should not be used in patients with moderate to severe kidney disease. In these patients, 

blood levels with the drug approach those associated with the occurrence of seizures. 

Ampyra will be manufactured under licenses from Elan of Dublin, Ireland, and distributed by 

Acorda Therapeutics Inc. of Hawthorne, N.Y. 

Article link: http://www.ptcommunity.com/Daily/DailyDetail.cfm?chosen=66013 


Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment 

[Posted 01/26/2010] Takeda Oncology and FDA notified healthcare professionals about 

revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with 

hepatic impairment at the start of Velcade therapy. The changes also include new safety 

information on dose adjustment for patients with moderate to severe hepatic impairment in label 

Section 5.11, stating: "Bortezomib is metabolized by liver enzymes. Bortezomib exposure is 

increased in patients with moderate or severe hepatic impairment; these patients should be 

treated with VELCADE at reduced starting doses and closely monitored for toxicities." 

Velcade is indicated for the treatment of patients with multiple myeloma. Velcade also is 

indicated for the treatment of patients with mantle cell lymphoma who have received at least one 

prior therapy. 

Article link: 




FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain 

[Posted January 26] - The U.S. Food and Drug Administration today approved Morphine Sulfate 

Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant 

patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. 

This is the only FDA approved morphine sulfate oral solution available at this concentration. 

Although the use of this medicine to manage pain has been common practice for many years, this 

form and concentration of morphine was not FDA approved until now. Today’s action is part of 

the FDA’s unapproved drugs initiative. As part of this program, the FDA has worked with the 

11

manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough 

drug available for patients. The FDA will also be working with patient organizations and 

prescribers so that they are aware that an approved product is available, and can notify the FDA 

if there are any problems with availability. “An important goal of the unapproved drugs initiative 

is to make sure that marketed drugs meet current FDA standards,” said Douglas Throckmorton, 

M.D., deputy director for the FDA’s Center for Drug Evaluation and Research. “Our action 

today reflects a careful balance between ensuring patient access to necessary medicines, while 

making sure companies comply with the law.” One benefit of the FDA approval process is a 

requirement for manufacturers to provide sufficient information on how to safely prescribe and 

use a drug. Manufacturers may also have to establish additional safety measures to manage 

unique risks of a medicine. For this formulation of morphine, the manufacturer had to develop a 

safety program prior to approval to address the known risks of morphine misuse, abuse and 

overdose. 

Article link: http://www.ptcommunity.com/Daily/DailyDetail.cfm?chosen=66017 


Zyprexa (olanzapine): Use in Adolescents 

[Posted January 29] - Lilly and FDA notified healthcare professionals of changes to the 

Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) 

for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised 

labeling states that: Section 1, Indications and Usage: When deciding among the alternative 

treatments available for adolescents, clinicians should consider the increased potential (in 

adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should 

consider the potential long-term risks when prescribing to adolescents, and in many cases this 

may lead them to consider prescribing other drugs first in adolescents. Section 17.14, Need for 

comprehensive Treatment Program in Pediatric Patients: Zyprexa is indicated as an integral part 

of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that 

may include other measures (psychological, educational, social) for patients with the disorder. 

Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 

13 years of age. 

Article link: 




Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal 

Hypertension 

[Posted January 29] - FDA notified healthcare professionals and patients about a rare, but 

serious, complication in the liver known as non-cirrhotic portal hypertension in patients using 

Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus 

(HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through 

adverse event reports submitted to FDA's Adverse Event Reporting System. Based on the 

number of well-documented cases and exclusion of other causes of portal hypertension such as 

alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of 

didanosine and development of non-cirrhotic portal hypertension. Because of the potential 

severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has 

revised the Warning and Precautions section of the didanosine drug label to assure safe use of the 

medication. FDA believes the clinical benefits of didanosine for certain patients with HIV 

12

continue to outweigh its potential risks. The decision to use this drug, however, must be made on 

an individual basis between the treating physician and the patient. 

Article link: 




Studies 

Antidepressant Pills May Help Only Most Severe Cases 

[Posted January 6] - Antidepressants such as those made by GlaxoSmithKline Plc may be no 

better than dummy pills for people with mild or moderate depression, according to a study that 

suggests 70 percent of patients wouldn’t benefit from the drugs. In a review of six trials of 

antidepressants involving more than 700 patients published yesterday in the Journal of the 

American Medical Association, researchers led by Jay Fournier at the University of 

Pennsylvania found the drugs helped only those patients with the most severe depression. Most 

trials excluded patients with milder forms of the disorder, the authors said. 

Article link: http://www.bloomberg.com/apps/news? pid=newsarchive&sid=aDTnaUDWwG_g 

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

Studies: Mental Ills Are Often Overtreated, Undertreated 

[Posted January 5] - More Americans are being prescribed multiple psychiatric medications for 

use at the same time, but most people diagnosed with recent depression don't get adequate 

treatment, according to two independent studies published Monday. In national surveys of more 

than 15,000 adults, researchers found that 8.3% met the diagnostic criteria for major depression 

during the previous year. About half those diagnosed received some form of treatment for 

depression, but less than a quarter were treated using strategies considered effective and used in 

accordance with American Psychiatric Association practice guidelines, one study found. 

Article link: http://online.wsj.com/article/ SB10001424052748703580904574638750777038042. 

html 

Source website: http://online.wsj.com 

US FDA cancels panel review of Lilly antidepressant 

[Posted January 5] - U.S. health officials have canceled an advisory panel review of Eli 

Lilly and Co's proposed new use for blockbuster antidepressant Cymbalta, the Food and Drug 

Administration said on Tuesday. The Jan. 28 meeting had been set to consider data from Lilly's 

application to promote Cymbalta for treatment of chronic pain. The meeting was canceled "to 

allow time for the FDA to review new information that is relevant to the benefit risk balance for 

the proposed new indication," an FDA notice said. 

Article link: http://www.reuters.com/article/idUSN0512308320100106 

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

Ginkgo extract doesn't slow cognitive decline 

[Posted December 29] - The widely used herbal supplement Ginkgo biloba does not appear to 

slow the rate of cognitive decline in healthy older people or those with mild cognitive 

impairment, U.S. researchers said on Tuesday. Their study involved 3,069 people age 72 or older 

13

from four U.S. communities who were tracked for an average of six years. Half of them took 

twice-daily doses of 120 milligrams of extract from the leaves of the ginkgo tree and half 

received a placebo. Compared with study participants who received a placebo, the use of Ginkgo 

biloba did not slow cognitive decline in those with normal conditions or those with mild 

cognitive impairment, the researchers wrote in the Journal of the American Medical Association. 

Article link: http://www.reuters.com/article/idUSTRE5BS3IH20091229 


FDA panel says Vytorin and Zetia probably don't cause cancer 

[Posted December 24] - A comprehensive review of previous studies involving the cholesterollowering 

drugs Vytorin and Zetia and two large ongoing studies shows that "it is unlikely that 

[they] increase the risk of cancer or cancer-related deaths," a Food and Drug Administration 

review committee has found. Zetia is the brand name for the drug ezetimibe, which blocks the 

absorption of cholesterol in the intestines. Vytorin is a combination of ezetimibe and simvastatin, 

which blocks the production of cholesterol by the body. 

Article link: http://latimesblogs.latimes.com/booster_shots/2009/12/fda-panel-says-vytorinandzetia-probably-dont-cause-cancer.html 

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

Merck Diarrhea Drug Reduces Repeat Infections by 72% in Study 

[Posted January 21] - Merck & Co.’s experimental drug against a germ blamed for increasing 

rates of deadly diarrhea in U.S. hospitals and nursing homes cut repeat infections by 72 percent, 

a study in the New England Journal of Medicine said. In a trial of 200 patients in the U.S. and 

Canada with diarrhea caused by a bacterium called Clostridium difficile, 7 percent of patients 

who added the medicine to a course of antibiotics had recurrent infections within 12 weeks, 

compared with 25 percent of those who only received antibiotics, the study found. 

Article link: http://www.bloomberg.com/apps/news?pid= newsarchive&sid=ayRBXd17AfnQ 


Wave of Mutant HIV May Undo Years of Drug Progress, Study Says 

[Posted January 15] - Strains of mutant HIV emerging in the U.S. and Europe threaten to 

undermine progress made in expanding access to treatment in poor countries, a study published 

online by the journal Science found. About 60 percent of drug-resistant HIV strains circulating in 

San Francisco can spur self-sustaining epidemics as patients who haven’t been treated spread 

them, researchers from the University of California, Los Angeles said in the study. Similar trends 

are emerging in other rich cities including New York, Chicago and London, said Sally Blower, a 

professor of mathematical biology, who led the research. 

Article link: http://www.bloomberg.com/apps/news?pid= newsarchive&sid=a0qEfj4bRpYc 


AstraZeneca, Sanofi, Merck Heart Drugs Cut Alzheimer’s Disease 

[Posted January 13] - Drugs commonly used to lower blood pressure, sold by AstraZeneca Plc, 

Sanofi-Aventis SA and Merck & Co., may also reduce the risk of developing Alzheimer’s 

disease. Researchers from Boston University analyzed the medical records of more than 800,000 

U.S. veterans and found those taking angiotensin receptor blockers were up to 24 percent less 

likely to develop dementia than patients on other medications. Patients already diagnosed with 

Alzheimer’s disease were half as likely to be admitted to a nursing home and had a 17 percent 

reduced risk of dying if they were taking the medications. 

Article link: http://www.bloomberg.com/apps/news? pid=newsarchive&sid=ar1_5S7blnPc 

14


Glaxo to Stop Pain Research, Start Rare-Disease Unit 

[Posted February 4] - GlaxoSmithKline Plc will halt research into drugs for depression and pain 

and begin making treatments for rare diseases as the U.K. company tries to squeeze more 

products out of its laboratories. Glaxo will also focus on discovering new medicines for 

Alzheimer’s and Parkinson’s diseases and multiple sclerosis, the London-based company said 

today in a statement. Chief Executive Officer Andrew Witty said an expanded cost-savings 

program would bring job cuts affecting “hundreds rather than thousands” of positions in the U.K. 

Article link: http://www.bloomberg.com/apps/news? pid=20601085&sid=a7TVq3PcLq.I 


Lancet Retracts Study Tying Child Vaccine to Autism 

[Posted February 2] - The Lancet medical journal retracted a 1998 study that linked a routine 

childhood vaccine to autism and bowel disease after a U.K. investigation found flaws in the 

research. The U.K. General Medical Council, which licenses doctors, concluded in a report last 

week that three researchers led by Andrew Wakefield at the Royal Free Hospital in London 

carried out invasive, unnecessary tests, failed to act in the best interest of the children, and 

misused public funds. It also said Wakefield didn’t disclose a conflict of interest as he was 

involved in legal claims against the vaccine makers. “It has become clear that several elements of 

the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier 

investigation,” the editors of the Lancet wrote in a statement today. 

Article link: http://www.bloomberg.com/apps/news?pid=news archive&sid=aHxWwOu0jSl4 


Mystery Medicine for Alzheimer’s May Yield Advance for Pfizer 

[Posted February 2] - Doctors may learn next month that Dimebon, a 27-year-old hay fever 

treatment and one of the most mysterious compounds yet tried to fight dementia, is poised to 

become their newest and perhaps best weapon against Alzheimer’s. Medivation Inc., the start-up 

that persuaded Pfizer Inc., the world’s biggest drugmaker, to help develop Dimebon, may be 

ready to release new research data during the first week of March, said Bengt Winblad, head of 

Alzheimer’s research at the Karolinska Institute in Stockholm and a leader of the European trials 

for the product. The study may confirm a 2008 finding in Russia that patients functioned better 

and thought more clearly after swallowing Dimebon tablets three times a day. 

Article link: http://www.bloomberg.com/apps/news?pid= 20601202&sid=a_K7yqGmtkpk 


Antidepressants May Help Stroke Patients Recover Mental Skills 

[Posted February 1] - Forest Laboratories Inc.’s antidepressant Lexapro may help stroke 

patients recover some of their mental skills, a study said. Patients who took Lexapro recovered 

more of their visual and verbal memory after 12 months of treatment than those given a placebo 

or those who underwent therapy without drugs, researchers reported today in the Archives of 

General Psychiatry. The University of Iowa study also found that those getting the antidepressant 

were more able to perform daily living activities. Each year, one-third of the 15 million people 

worldwide suffering a stroke are left permanently disabled, according to the World Health 

Organization. Declines in mental skills are a major contributor to that disability, the study said. 

The annual costs of stroke are estimated to be $65.5 billion in the U.S., according to the 

American Heart Association. 

Article link: http://www.bloomberg.com/apps/news?pid= 20601124&sid=a5YjyBqe2_i4 

15


Opiate painkillers raise fracture risk 

[Posted January 25] – Older adults who take powerful prescription painkillers known as 

opioids face an increased risk of bone fractures, especially at moderately high medication doses, 

a new study finds. Opioids are powerful narcotic pain medications that include morphine, 

oxycodone (Oxycontin and other brands) and hydrocodone (Vicodin and others). The drugs work 

well against severe pain in the short term, but their longer-term effectiveness for chronic pain is 

less clear. Moreover, with longer use comes the risk of addiction, in addition to side 

effects such as nausea, constipation, dizziness and sedation. 

Article link: http://news.yahoo.com/s/nm/20100125/hl_nm/us_opiate_painkillers 

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

Biovail Has Issues With Teva's Wellbutrin XL Study 

[Posted January 22] - Biovail Corp. (BVF) has broken its silence on a clinical trial involving its 

Wellbutrin XL drug and a generic version, saying the study doesn't go far enough to address 

consumer complaints. The first-of-its-kind trial, being led by Teva Pharmaceutical Industries 

Ltd. and Impax Laboratories Inc. will pit the generic - Budeprion XL - against the branded 

version. It was first reported by Dow Jones in December."Based on the limited information that 

has been made available about the clinical trial by Teva, Biovail believes the proposed study will 

not likely effectively address the complaints of consumers because it is too small in size and too 

brief in duration," Biovail said in a release. 

Article link: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid= 

201001221646dowjonesdjonline 000632&title=biovail-has-issues-with-tevas-wellbutrin-xl-study 

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

Roche says Xelox cancer drug effective in elderly 

[Posted January 21] - Roche's cancer drug Xeloda enabled elderly patients being 

treated for colorectal cancer to live free of the disease for longer, the world's largest maker of 

cancer drugs said on Thursday. A study showed that patients above the age of 65 who took 

Xelox, which is oral Xeloda combined with intravenous oxaliplatin, immediately after surgery 

lived disease-free for longer compared with those treated with commonly used chemotherapy 

regimen 5-fluorouracil/leucovorin. 

Article link: http://www.reuters.com/article/idCNLDE60K05A20100121?rpc=44 


Cost of Psoriasis Drugs Rising Faster Than Others 

[Posted January 18] - The cost of treating psoriasis is rising faster than inflation, says a U.S. 

study, which also found that newer, biologically-derived treatments cost more than traditional 

systemic therapies. The researchers created a cost model to analyze the total cost of systemic 

therapy for psoriasis, a chronic autoimmune skin disease that affects 4.5 million to 7.5 million 

Americans and costs the nation's health-care industry more than $3 billion a year. The cost for 

each type of systemic therapy (such as oral medications) was calculated by using the average 

wholesale price of each drug plus the cost of office visits, laboratory tests and monitoring. 

"Current total and annual costs for systemic psoriasis therapies ranged from $1,197(methotrexate 

[a traditional systemic therapy]) to $27,577 (alefacept [a biologic], two 12-week courses)," wrote 

Dr. Vivianne Beyer of St. Vincent Hospital in Indianapolis and Dr. Stephen E. Wolverton of the 

Indiana University School of Medicine. Costs for phototherapy (exposure to ultraviolet light) 

ranged from $3,083 to $7,288, and costs for biologics ranged from $18,384 to $27,577. 

16

Article link: http://www.businessweek.com/lifestyle/content/healthday/635029.html 

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

Pfizer's Kidney Drug Also Slows Pancreatic Cancer 

[Posted January 22] -Drug giant seeks regulatory approval for Sutent as a pancreatic cancer 

treatment. Pfizer Inc., the world’s biggest drugmaker, said Friday a late-stage trial of Sutent 

reveals that the kidney cancer treatment also helps slow the growth of rare pancreatic 

neuroendocrine tumors. Final results from a randomized Phase 3 trial of Sutent, which is 

approved to treat renal cell carcinoma, a type of kidney cancer, and as a backup treatment for 

rare tumors found in the gastrointestinal tract, indicate the drug also curbs the progression of a 

type of cancer which originates in the hormone-producing area of the pancreas. 

Article link: http://www.forbes.com/2010/01/22/pfizer-drug-trial-markets-equitiespancreaticcancer.html?feed=rss_markets 

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

Recalls 

PRODUCT (Class II recall) 

Tylenol Arthritis Pain, (acetaminophen), extended-release caplets, 650 mg, 100 count bottles 

with EZ-open cap, NDC 50580-112-21. Recall # D-137-2010 

CODE 

Lot 08BMC020-Exp. 11/30/2010, 07CMCO11-Exp. 1/31/2010, 07DMC024-Exp. 1/31/2010, 

07HMC051-Exp. 1/31/2010, 07JMC064-Exp. 1/31/2010, 07DMC022-Exp. 2/28/2010, 

07GMC038-Exp.2/28/2010, 08AMC002-Exp.2/28/2010, 07FMC032-Exp.3/31/2010, 

07FMC033-Exp. 3/31/2010, 07GMC039-Exp. 4/30/2010, 07HMC045-Exp. 4/30/2010, 

07HMC053-Exp. 5/31/2010, 07XMC055-Exp5/31/2010, 07JMC069-Exp. 6/30/2010, 

07JMC070-Exp.6/30/2010, 07XMC058-Exp.6/30/2010, 07XMC062-Exp.6/30/2010, 

08AMC005-Exp. 6/30/2010, 07JMC071-Exp. 7/31/2010, 08CMC026-Exp. 9/30/2010, 

08DMC029-Exp.1/31/2011, 08EMC037-Exp. 2/28/2011, 08EMC039-Exp. 2/28/2011; 

08FMC044-Exp. 2/28/2011, 08FMC045-Exp. 3/31/2011, 08GMC050-Exp. 3/31/2011, 

08GMC053-Exp. 4/30/2011, 08GMC063-Exp. 4/30/2011, 08GMC065-Exp 4/30/2011, 

08KMC124-Exp. 5/31/2011, 08XMC093-Exp. 7/31/2011, 08XMC094-Exp. 7/31/2011, 

08XMC095-Exp. 7/31/2011, 08JMC103-Exp. 8/31/2011, 08JMC109-ExP. 8/31/2011, 

08JMCll0-Exp. 8/31/2011, 08JMC111-Exp. 8/31/2011, 08KMC127-Exp. 8/31/2011, 

08KMC131-Exp. 10/31/2011, 08KMC132-Exp. 10/31/2011, 09AMC010-Exp. 10/31/2011, 

09BMC034-Exp. 12/31/2011, 09CMC036-Exp. 12/31/2011, 09CMC040-Exp. 1/31/2012, 

09CMC041-Exp.1/31/2012, 09EMC075-Exp. 2/28/2012, 09EMC076-Exp. 2/28/2012, 

09GMC096-Exp. 2/28/2012, 09GMC097-Exp. 2/28/2012, 09EMC079-Exp. 3/31/2012, 

09GMC099-Exp. 4/30/2012, 09XMC116-Exp. 5/31/2012, 09JMC118-Exp. 7/31/2012, 

09JMC126-Exp. 7/31/2012, 09XMC114-Exp. 7/31/2012, 09KMC133-Exp.9/30/2012, 

09KMC134-Exp.10/31/2012 

RECALLING FIRM/MANUFACTURER 

Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 

by website on November 6, 2009, press release on December 18, 2009 and by letters on 

November 9, 2009 and December 18, 2009. 

Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. Firm initiated 

recall is ongoing. 

17

REASON 

Chemical Contamination: The product recall was initiated after identifying an uncharacteristic 

smell and taste associated with the presence of a chemical called 2, 4, 6,-tribromoanisole. The 

source of this chemical is believed to be from the breakdown of a chemical compound used to 

treat the wood pallets that are used for the transportation and storage of packaging materials. 

VOLUME OF PRODUCT IN COMMERCE 

6,329,760 bottles 

DISTRIBUTION 

Nationwide, United Arab Emirates (UAE), and Kuwait 


Milk of Magnesia (magnesium hydroxide), 1200 mg Saline Laxative, Cherry Liquid 12 FL oz, 

NDC # 59779-949-40, UPC 5042807094. Recall # D-138-2010 

CODE 

9DK0168, 9DK0376, 9EK0118, 9EK0173, 9EK0367, 9EK0525, 9FK0044, 9FK0256, 9FK0425, 

9FK0521, 9GK0049, 9GK0308, 9GK0436, 9GK0668, 9HK0106, 9HK0285, 9HK0372 and 

9JK0126 


L. Perrigo Co., Allegan, MI, by letter on November 24, 2009. Firm initiated recall is ongoing. 

REASON 

Labeling: Label mix-up; Product is labeled as sugar-free but it actually contains sugar. 


72,840 bottles 

DISTRIBUTION 

Nationwide. Sold only at CVS stores. 


Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL, For Subcutaneous Use Only, Rx only. a) 

NDC 58406-445-04: 4 single- use prefilled autoinjectors per carton, b) NDC 58406-445-01: 1 

single-use prefilled autoinjector. Recall # D-327-2010 

CODE 

a) 1005228, exp 3/2011; 1006109, exp 5/2011; 1010348, exp 6/2011; 1005945, exp 3/2011; 

1007963, exp 5/2011; 1010349, exp 11/2011; 1005946, exp 3/2011; 1007964, exp 6/2011; 

1010570, exp 9/2011; 1006035, exp 4/2011; 1009200, exp 5/2011; 1011162, exp 12/2011; 

1006091, exp 2/2011; 1009201, exp 5/2011; 1011235, exp 1/2012; 1006092, exp 4/2011; 

1009202, exp 6/2011; 1011236, exp 1/2012; 1006095, exp 4/2011; 1009203, exp 6/2011; 

1011237, exp 2/2012; 1006100, exp 4/2011; 1009206, exp 10/2011; 1011875, exp 2/2012; 

1006106, exp 5/2011; 1009726, exp 11/2011; 1012737, exp 2/2012; 1006107, exp 5/2011; 

1010346, exp 4/2011; 1006108, exp 5/2011; 1010347, 5/2011; b) 1006119, exp 4/2011; 

1006771, exp 5/2011; 1006774, exp 6/2011; 1007225, exp 4/2011; 1007795, exp 4/2011; 

1010351, exp 12/2011 


Amgen Manufacturing, Limited, Juncos, PR, by letter on September 14, 2009 and January 18, 

2010. Firm initiated recall is ongoing. 

REASON 

Lack of Assurance of Sterility: Syringe barrel flange that slightly deviated from the center line of 

the syringe barrel, resulted in broken or cracked syringes. 


2,948,741 syringes 

18

DISTRIBUTION 

Nationwide 

PRODUCT (Class III recall) 

Multitrace-5 Concentrate (Trace Elements Injection 5, USP), 1 mL Single Dose Vial, for IV use 

after dilution, Rx Only, NDC 0517-8201-25. Recall # D-140-2010 

CODE 

Lot 8033, 8520, 9317 


Luitpold Pharmaceuticals, Inc., Shirley NY, letters dated August 26, 2009 via fax and UPS mail. 

Firm initiated recall is ongoing. 

REASON 

Out-of-specification product for aluminum levels. 


187,825 

DISTRIBUTION 

Nationwide 


1) ALCAINE (proparacaine hydrochloride USP) ophthalmic solution, 0.5%, 15ML, Sterile, Rx 

Only, NDC 0998-0016-15. Cardinal Item #1258490. Recall # D-141-201; 

2) ALPROSTADIL (prostaglandin E1), 500MCG/ML 5 X 1ML, Rx Only, NDC 0703-1501-02. 

Cardinal Item #2887784. Recall # D-142-2010; 

3) AMBISOME INJECTION (amphotericin B) liposome for injection, 50mg, 1 vial, Rx Only, 

NDC #0469-3051-30. Cardinal Item #2613164. Recall # D-143-2010; 

4) AMPHADASE INJECTION (Hyaluronidase Injection, USP), Not for IV use. 150 U/mL, 10x1 

mL PFL, Rx only, NDC 0548-9090-10. Cardinal Item #3662335. Recall # D-144-2010; 

5) AMPHADASE INJECTION, (Hyaluronidase Injection, USP), Not for IV use. 150 U/mL 25 x 

1 mL PFL, Rx only, NDC #0548-9090-00. Cardinal Item #3621331. Recall # D-145-2010; 

6) AMPHOTERICIN B FOR INJECTION. 50MG 1Vial, Rx Only, NDC #39822-1055-7. 

Cardinal Item #3722618, Recall # D-146-2010; 

7) AMPHOTERICIN B FOR INJECTION 50MG 1Vial, Rx Only, NDC #39822-1055-5. 


8) AMYL NITRITE INHALANT, USP, 12 0.3ML ampule, Rx only, NDC #39822-9950-2. 


9) APIDRA INJECTABLE [insulin glulisine (rDNA origin) injection], 100U/ML 10ML, Rx 

Only, NDC #0088-2500-33. Cardinal Item #3707817. Recall # D-149-2010; 

19

10) APIDRA INJECTABLE [insulin glulisine (rDNA origin) injection], 100U/ML 5X3ML, For 

use only in OPTICLIK Insulin Delivery Device, Rx Only, NDC #0088-2500-52. Cardinal Item 

#3707775. Recall # D-150-2010; 

11) APTIVUS (tipranovir) 250MG 120 SOFTGEL Capsules, Rx only, NDC #0597-0003-02. 


12) AQUASOL A Parenteral Water-Miscible, Vitamin A Palmitate, Solution 50MU/ML 

10X2ML, Rx Only, NDC #61703-418-07. Cardinal Item #3722931. Recall # D-152-2010; 

13) AVONEX, 30MCG 4 Prefilled Syringe, Rx Only, NDC #59627-002-05. Cardinal Item 


14) BACIIM" (Bacitracin for Injection USP), Powder for Inj. Solution 50MU 10 VIALS, For 

Intramuscular Use, Rx Only, NDC #39822-0277-7. Cardinal Item #3689494. Recall # D-154- 

2010; 

15) BACIIM" (Bacitracin for Injection USP) Powder for Inj. Solution 50MU 10VIAL, Rx Only, 


16) BACITRACIN FOR INJECTION 50MU 1VIAL, Rx Only, NDC #0009-0233-01. Cardinal 

Item #1323898. Recall # D-156-2010; 

17) BACITRACIN FOR INJ. 50MU 1Vial, Rx Only, NDC #63323-329-30. Cardinal Item 


18) BLEOMYCIN FOR INJECTION, UPS, equivalent to 15 Units Bleomycin, Single use 1Vial, 

For IV, IM, SC or Intrapleural Use, Rx Only, NDC #0703-3154-91. Cardinal Item #3339819. 

Recall # D-158-2010; 

19) BLEOMYCIN FOR INJECTION 15U 1Vial, Rx Only, NDC #0703-3154-01. Cardinal Item 

#3216934. Recall D-159-2010; 

20) BLEOMYCIN FOR INJECTION 30U 1Vial, Rx Only, NDC #0703-3155-01. Cardinal Item 


21) CANCIDAS (caspofungin acetate) FOR INJECTION 50MG 1Vial, Rx only, NDC #0006- 

3822-10. Cardinal Item #3006848. Recall # D-161-2010; 

22) CANCIDAS (caspofungin acetate) POWDER FOR INJECTION, 70MG 1VIAL, Rx Only, 


23) CAVERJECT, 40MCG 6 VIAL, Rx Only, NDC #0009-7686-04. Cardinal Item #2691582. 

Recall #D-163-2010; 

24) CENOLATE INJ. 500MG/ML (Ascorbic Acid Injection, USP), Single Dose, 50X1ML, Rx 

only, NDC #0409-3118-31. Cardinal Item #2471647. Recall # D-164-2010; 

20

25) CENOLATE INJ. 500MG/ML 50X2ML, (Ascorbic Acid Injection, USP), Single Dose, Rx 


26) CEREBYX INJ. (Fosphenytoin Sodium Injection), 50MG/ML 10X10ML, (PE=phenytoin 

sodium equivalent), Rx only, NDC #0071-4008-10. Cardinal Item #2503449. Recall # D-166- 


27) CEREBYX INJ. (Fosphenytoin Sodium Injection), 50MG/ML 25X2ML, (PE=phenytoin 

sodium equivalent), Rx only, NDC #0071-4007-05. Cardinal Item #2503456. Recall # D-167- 


28) CLADRIBINE INJECTION, 1MG/ML 10ML, Single Dose Vial, For Intravenous Infusion, 

Rx only, NDC #63323-140-10. Cardinal Item #36000665. Recall # D-168-2010; 

29) CLEVIPREX" (clevidipine butyurate injectable emulsion), 0.5MG/ML, 10X100ML, Rx 


30) CLORPACTIN WCS-90, 5X2GM, (Brand of Oxychlorosene, Sodium), OTC, NDC #0327- 


31) CUROSURF (poractant alfa) Intratracheal Suspension, 80MG/ML 1.5ML single use vial, Rx 


32) CUROSURF (poractant alfa) Intratracheal Suspension, 80MG/ML 3ML single use vial, Rx 

Only, NDC #49502-180-03. Cardinal Item #2942837, Recall # D-172-2010; 

33) DESMOPRESSIN ACETATE NASAL SOLUTION 0.1MG/ML 5ML, Rx Only, NDC 

#24208-342-05. Cardinal Item #2700888. Recall # D-173-2010; 

34) DESMOPRESSIN ACETATE INJ. 4MCG/ML 10X1ML, Rx Only, NDC #0409-2265-01. 


35) DESMOPRESSIN ACETATE 4MCG/ML 10ML, Rx Only, NDC #0703-5054-01. Cardinal 


36) DESMOPRESSIN ACETATE 4MCG/ML 10 X 1ML, Rx Only, NDC #0703-5051-01. 


37) DILTIAZEM Hydrochloride Injection, 5MG/ML 10X10ML, Single-dose Fliptop Vial, For 

Direct I.V. Bolus Injection and Continuous I.V. Infusion, Rx only, NDC #0409-1171-02. 


38) DILTIAZEM Hydrochloride Injection, 5MG/ML 10X5ML, Single-dose Fliptop Vial, For 

Direct I.V. Bolus Injection and Continuous I.V. Infusion, Rx only, NDC #0409-1171-01. 


39) DOXIL (doxorubicin HCl Liposome injection), INJ. 2MG/ML 10ML,sterile, single use vial, 

For Intravenous Infusion Only, Rx Only, NDC #17314-9600-1. Cardinal Item #2408839. Recall 

# D-179-2010; 

21

40) DOXIL (doxorubicin HCl Liposome injection), INJ. 2MG/ML 25ML, sterile, single use vial, 

For Intravenous Infusion Only, Rx Only, NDC #17314-9600-2. Cardinal Item #2990497. Recall 


41) ELIGARD (leuprolide acetate for injectable suspension), 22.5MG FOR INJ. SUSPENSION, 

Sterile, for subcutaneous injection, Rx Only, NDC #0024-0222-05. Cardinal Item #3531712. 


42) ELIGARD (leuprolide acetate for injectable suspension), 45MG, Rx Only, US, NDC #0024- 

0605-45. Cardinal Item #3647286, Recall # D-182-2010; 

43) ELIGARD (leuprolide acetate for injectable suspension), 7.5MG, Rx Only, NDC # 0024- 


44) ELIGARD (leuprolide acetate for injectable suspension), 30MG, Sterile, Rx only, NDC 

#0024-0610-30. Cardinal Item #3481678, Recall # D-184-2010; 

45) EMCYT CAPSULES, (estramustine phosphate), 140MG 100, Rx Only, NDC #0013-0132- 

02. Cardinal Item #1058023. Recall # D-185-201; 

46) EMEND (fosaprepitant dimeglumine) for Injection, 115MG 1VIAL, Rx only, NDC #0006- 


47) EPIRUBICIN HCL INJ., 2MG/ML 100ML, For IV Use Only, Cytotoxic Agent, Rx only, 


48) FLUDARABINE PHOSPHATE FOR INJECTION, 25MG/ML 2ML, Single Dose Vial For 

IV Use Only, Rx only, NDC #0703-4852-11. Cardinal Item #3580826. Recall # D-188-2010; 

49) FLUDARABINE PHOSPHATE FOR INJECTION 50MG 1VIAL, Single Dose Vial For IV 

Use Only, Rx only, NDC #0703-5854-01. Cardinal Item #3515947. Recall # D-188-2010;D-189- 


50) FORADIL Aerolizer (formoterol fumarate inhalation powder), 12MCG 12 Capsules with 

Device, Rx only, NDC #0085-1402-01. Cardinal Item #3459971. Recall # D-190-2010; 

51) FORADIL Aerolizer (formoterol fumarate inhalation powder), 12MCG 60 Capsules with 

Device, Rx only, NDC #0085-1401-01. Cardinal Item #3459955. Recall # D-191-2010; 

52) FORTEO (teriparatide [rDNA origin]) Injection, 250MCG/ML 3ML, For subcutaneous use. 


53) FOSPHENYTOIN SODIUM INJECTION USP, 50MG/ML 10X10ML Single Dose Vials, 

(PE=phenytoin sodium equivalents), For IM or IV Use, Rx only, NDC #64679-730-01. Cardinal 


54) FOSPHENYTOIN SODIUM INJECTION USP, 50MG/ML 10X10ML Single Dose Vials, 



22

55) FOSPHENYTOIN SODIUM INJECTION USP, For IM or IV use, Rx only, 50MG/ML 

10X2ML Single Dose Vials, NDC #55390-175-10. Cardinal Item #4001368. Recall # D-195- 


56) FOSPHENYTOIN SODIUM INJECTION, For IM or IV use, Rx only, 50MG/ML 

10X10ML Single Dose Vials, Rx only, NDC #55390-176-10. Cardinal Item #4001376. Recall # 

D-196-2010; 

57) FOSPHENYTOIN SODIUM INJECTION, USP, 50MG/ML 10X10ML Single Dose Vials, 

(PE=phenytoin sodium equivalents), Rx only, NDC #0409-4857-10. Cardinal Item #4001343. 


58) FOSPHENYTOIN SODIUM INJECTION, USP, 50MG/ML 25X2ML Single Dose Vials, 



59) FOSPHENYTOIN SODIUM 50MG/ML 10 X 10ML, Rx Only, NDC #0703-7105-03. 


60) FOSPHENYTOIN SODIUM 50MG/ML 25 X 2ML, Rx Only, NDC #0703-7101-04. 


61) FOSPHENYTOIN SODIUM, 50MG/ML 10 X 10ML, Rx Only, NDC #63323-403-10. 


62) HUMATROPE CARTRIDGE KIT, (somatropin [rDNA origin]) for injection, 12MG for use 

with the Humatrope pen injection device, Rx only, NDC #0002-8148-01. Cardinal Item 


63) HUMATROPE FOR INJ. (somatropin [rDNA origin]) for injection, 5MG for use with the 

Humatrope pen injection device, Rx only, NDC #0002-7335-16. Cardinal Item #3740214. Recall 


64) HUMATROPE CARTRIDGE KIT (somatropin [rDNA origin]) for injection, 6MG for use 

with the Humatrope pen injection device, Rx only, NDC #0002-8147-01. Cardinal Item 


65) IDARUBICIN HCL INJECTION, 1MG/ML 5ML, Single Dose Vial, For Intravenous Use 

Only, Rx only, NDC #0703-4154-11. Cardinal Item #3421864. Recall # D-205-2010; 

66) IDARUBICIN HCL INJ. 1MGML 20ML, Single Dose Vial, For Intravenous Use Only, Rx 


67) LEUKERAN (chlorambucil) Tablets 2MG 50 Tablets, Rx only, NDC #0173-0635-35. 


68) M.V.I. ADULT (Multi-Vitamin Infusion), For Dilution in Intravenous Infusions only, 

10ML/2VIALX10 Units to be used as a single dose only, Rx only, NDC #61703-422-82. 


23

69) M.V.I. ADULT (Multi-Vitamin Infusion), For Dilution in Intravenous Infusions 10X10ML 

Units to be used as a single dose only, Rx only, NDC #61703-422-81. Cardinal Item #3732211. 


70) M.V.I. PEDIATRIC (Multi-Vitamin Infusion), For Reconstitution and Dilution in 

Intravenous Infusions Only, Ten 5ML Single Dose Vials, Sterile, Rx only, NDC #61703-421-53. 


71) M.V.I.-12 (Multi-Vitamin Infusion Without Vitamin K) Unit Vial, For Dilution in 

Intravenous Infusions Only, 10 Unit Vials of 10ML each to be used as a single dose, Rx only, 


72) M.V.I.-12 (Multi-Vitamin Infusion without Vitamin K) 50ML/2VIALX10, Rx only, NDC 


73) NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION, 

10X1ML, A Concentrated Sterile Antibiotic Solution to be Diluted for Urinary Bladder 

Irrigation. Rx Only, NDC #39822-1201-2. Cardinal Item #3722584. Recall # D-213-2010; 

74) NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION, USP 

(Sterile), A Concentrated Sterile Antibiotic Solution to be Diluted for Urinary Bladder Irrigation, 

10ML, Rx only, NDC #39822-1220-1. Cardinal Item #3722600. Recall # D-214-2010; 

75) NEOMYCIN AND POLYMYXIN B SULFATE SOLUTION FOR IRRIGATION, 10X1ML 

Ampules, Rx only, NDC #0591-2190-45. Cardinal Item #3744695. Recall # D-215-2010; 

76) NEOMYCIN/POLYMYXIN B 50X1ML IRRIGATION, Rx Only, NDC #39822-1201-5. 


77) NORDITROPIN CARTRIDGE Somatropin (rDNA origin) Injection, 15MG/1.5ML, for use 

only with a green color-coded NoridPen, Rx only, NDC #0169-7770-11. Cardinal Item 


78) NORDITROPIN CARTRIDGE Somatropin (rDNA origin) Injection, 5MG/1.5ML, Rx only, 


79) NORDITROPIN NORDIFLEX (Somatropin [rDNA origin]) Injection 10MG/1.5ML, Rx 


80) NORDITROPIN NORDIFLEX (Somatropin [rDNA origin]) Injection 5MG/1.5ML Prefilled 

Pen, Rx only, NDC #0169-7704-11. Cardinal Item #3644747. Recall # D-220-2010; 

81) NYSTAT-Rx, NYSTATIN USP, 150Million Units, 1GM Bulk, For use in extemporaneous 

preparation of the oral suspension & prescription compounding, Not Sterile, Rx Only, NDC 


82) OCTREOTIDE ACETATE INJECTION, 0.5MG/ML 10X1ML, Single Dose Vials, For 

Subcutaneous Injection, Rx only, NDC #55390-162-10. Cardinal Item #3657335. Recall # D- 

222-2010; 

24

83) OCTREOTIDE ACETATE INJECTION, 0.2MG/ML 5ML, Single Dose Vials, Multiple 

dose vial, Rx only, NDC #55390-163-01. Cardinal Item #3657343. Recall # D-223-2010; 

84) OCTREOTIDE ACETATE INJECTION, 0.1MG/ML 10X1ML Single Dose Vials, For 



85) OCTREOTIDE ACETATE INJECTION, 1MG/ML, 5ML Multiple Dose Vial, For 



86) NORVIR (Ritonavir Capsules) 100MG, 30 Soft Gelatin Capsules, Rx Only, NDC #0074- 


87) OMNITROPE (Somatropin [rDNA origin] for injection) and diluent with preservation 

(Bacteriostatic Water for Injection 1.14mL) 5.8MG, Rx Only, NDC #0781-4004-36. Cardinal 


88) OMNITROPE" (Somatropin [rDNA origin] infection, 5MG/1.5ML CARTRIDGE, Rx Only, 

NDC #0781-3001-07. Recall # D-228-2010; 

89) OVIDREL (choriogonadotropin alfa injection) Prefilled Syringe, 250MCG, 0.5ML, Rx 


90) PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 5mg/5ml, 120 ml bottle, 


91) S-2 2.25% 30 X 0.5ML STERILE INHALATION, OTC, NDC #0487-5901-99. Cardinal 


92) SOLUCLENZ RX GEL (Benzoyl Peroxide 5%), 27ML, Rx Only, NDC #62032-121-10. 


93) SURVANTA, (beractant) intratracheal suspension, Sterile Suspension For Intratracheal 

Administration Only, Not for Injection, 25MG/ML 4ML Single Use Vial, Rx only, NDC #0074- 


94) SURVANTA (beractant) intratracheal suspension, 25MG/ML 8ML, Sterile Suspension For 

Intratracheal Administration Only, Not for injection, Rx Only, NDC #0074-1040-08. Cardinal 


95) SYPRINE (Trientine Hydrochloride), 250MG Capsule X 100 Capsules, Rx only, NDC 


96) TETRACAINE HCL 1% (Tetracaine HCl Injection), USP, for Prolonged Spinal Anesthesia, 

25 X 2ML, Rx only, NDC #11098-045-32. Cardinal Item #3605250. Recall # D-236-2010; 

25

97) TEV-TROPIN" [Somatropin (rDNA origin) for Injection] 5MG 1Vial with Diluent, 

Reconstitute with Bacteriostatic 0.9% Sodium Chloride Injection, USP (Benzil Acolhol 

Preserved), Rx only, NDC #57844-713-19. Cardinal Item #4005211. Recall # D-237-2010; 

98) TORISEL KIT, (temsirolimus), 25MG With Diluent, Rx Only, NDC #0008-1179-01. 


99) TRIFLURIDINE OPHTHALMIC SOLUTION, 1% 7.5ML Sterile, Rx only, NDC #61314- 


100) VFEND (voriconazole) For Oral Suspension, Orange Flavored, 40MG/ML 75ML, Rx only, 


101) VINCASAR PFS (vincristine sulfate injection, USP), 1MG/ML 1ML, Single Dose Vial, Rx 


102) VINCASAR PFS (vincristine sulfate injection, USP), 2MG/ 2ML, Single Dose Vial, Rx 


103) VINORELBINE TARTRATE INJECTION equivalent to vinorelbine, 10MG/ML 5ML 

Single-Use Vial, For Intravenous Use Only, Rx only, NDC #0703-4183-91. Cardinal Item 


104) VINORELBINE TARTRATE INJECTION, equivalent to vinorelbine, For Intravenous use 

only, 10MG/ML 5ML Single-Use Vial, For Intravenous Use Only, Rx only, NDC #0703-4183- 

01. Cardinal Item #3450699. Recall # D-244-2010; 

105) VIROPTIC OPHTHALMIC SOLUTION 1% (trifluuridine ophthalmic solution) Sterile, 

7.5ML Drop Dose, Rx Only, NDC #61570-037-75. Cardinal Item #1341023. Recall # D-245- 


106) VITRASE (hyaluronidase injection) Ovine Kit, 200U/ML 6 Single Use Vials X 1.2ML, Rx 


107) ZANOSAR (streptozocin sterile powder) 1GM 1 Single Dose Vial, For Intravenous Use 

Only, Rx only, NDC #0703-4636-01. Cardinal Item #3535937. Recall # D-247-2010; 

108) INFASURF (calfactant), 35MG/ML 3ML Suspension, Single use vial, Rx only, NDC 

#0456-4600-03. Cardinal Health number: 3544327. Recall # D-248-2010; 

109) INFASURF (calfactant), 35MG/ML 6ML Suspension, Single use vial, Rx only, NDC 


110) PREMARIN Intravenous (conjugated estrogens, USP) for injection, 25MG 1Vial, Rx only, 

Wyeth, NDC #0046-0749-05. Cardinal Health number: 1124528. Recall # D-250-2010; 

111) NORVIR (Ritonavir Capsules) Soft Gelatin, 100MG 30 capsules, Rx Only, NDC #0074- 

6633-30. Cardinal Health number: 3641016. Recall # D-251-2010; 

26

112) NIMBEX Injection (cisatracurium besylate), 2MG/ML 10 X 5ML, Rx Only, NDC # 0074- 

4378-05. Cardinal Health number: 3011335. Recall # D-252-2010; 

113) NIMBEX Injection (cisatracurium besylate), 200MG 10MG/ML 20ML, Rx Only, NDC 


114) NIMBEX Injection (cisatracurium besylate), 20MG 2MG/ML 10 X 10ML, Rx Only, NDC 


115) AMEVIVE IM KIT, 15 mg, 4 vials of lyophilized powder for injection, Rx Only, NDC 


116) AMEVIVE IM KIT 15 mg, 1 vial lyophilized powder for injection, Rx Only, NDC #0469- 


117) ARANESP (darpepoetin alfa) recombinant, 150MCG/0.75ML, 4 X 0.75ML Single Use 

Vials, Rx Only, NDC #55513-053-04. Cardinal Item #3772696. Recall # D-257-2010; 

118) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 40MCG/0.4mL, 4 X 0.4 mL, Rx 


119) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 150MCG/0.3mL, 4 X 0.3mL, 

Rx Only, NDC #55513-027-04. Cardinal Item #3772712. Recall # D-259-2010; 

120) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 60MCG/0.3mL, 4 X 0.3mL, Rx 


121) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 500MCG/1ML, Rx Only, NDC 


122) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 25MCG/0.4mL, 4 X 0.4mL, Rx 


123) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 200MCG/0.4mL, Rx Only, 


124) ARANESP,(darpepoetin alfa) recombinant, SINGLEJECT 100MCG/0.5mL, 4 X 0.5mL, 


125) ARANESP (darpepoetin alfa) recombinant, SURECLICK 40MCG/0.4mL, Rx Only, NDC 


126) ARANESP (darpepoetin alfa) recombinant, SURECLICK 200MCG/0.4mL, Rx Only, NDC 


127) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 300MCG/0.6mL, Rx Only, 


27

128) ARANESP (darpepoetin alfa) recombinant, 200MCG/ML 1ML Single Use Vials, Rx only, 


129) ARANESP (darpepoetin alfa) recombinant, 25MCG/ML, 4 X 1ML Single Use Vials, Rx 


130) ARANESP (darpepoetin alfa) recombinant, 300MCG/ML, 1ML Single Use Vials, Rx only, 








134) 134) AVASTIN INJ. (bevacizumab), 25MG/ML 16ML, List No. 16482, Single Use Vial, 

For Intravenous Use, Rx only, NDC #50242-061-01. Cardinal Item #3617701. Recall # D-274- 


135) AVASTIN INJ. (bevacizumab), 25MG/ML 4ML, List No. 15734, Single Use Vial, For 

Intravenous Use, Rx only, NDC #50242-060-01. Cardinal Item #3556156. Recall # D-275-2010; 

136) AVONEX (Interferon beta-la), 30MCG, 4 VIAL, Rx only, NDC #59627-001-03. 


137) CATHFLO ACTIVASE (ALTEPLASE), Powder for Inj. 2MG 1VIAL, For Use in Central 

Venous Access Devices, Rx only, NDC #50242-041-64. Cardinal Item #3289915. Recall # D- 


138) DDAVP Rhinal Tube, (desmopressin acetate), FOR Intranasal Use Only, 10MCG/0.1mL, 

2.5ML, Rx Only, NDC #0075-2450-01. Recall # D-278-2010; 

139) AMGEN ENBREL (etanercept), SURECLICK 50mg/mL, 4 Single-use Prefilled SureClick 

Autoinjectors, Rx only, NDC #58406-445-04. Cardinal Item #3742848. Recall # D-279-2010; 

140) AMGEN ENBREL (etanercept), 25MG/4 Multiple-use Vial, Rx only, NDC #58406-425- 


141) AMGEN ENBREL (etanercept), 25MG/0.5ML, 4 Single-use Prefilled Syringes, Rx Only, 


142) AMGEN ENBREL (etanercept), 4 x 50MG/ML Single-use Prefilled Syringes, Rx only, 


143) AMGEN EPOGEN, (EPOETIN ALFA, recombinant), 10MU/ML 10X2ML Single Use 

Vials, Rx only, NDC #55513-283-10. Cardinal Item #2254944. Recall # D-283-2010; 

28

144) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 10MU/ML 10X1ML Single Use 


145) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 20MU/ML 10 X 1ML Single Use 










150) HERCEPTIN KIT (Trastizibab), 440MG Multi-dose Vial, Rx only, NDC #50242-134-68. 


151) HUMIRA PEN (adalimumab) 40MG/0.8ML 27G Needle 2 Single-Use Prefilled Pens, For 

Subcutaneous Use Only, Rx only, NDC #0074-4339-02. Cardinal Item #3744547. Recall # D- 


152) HUMIRA PEN (adalimumab) 40MG/0.8ML 27G Needle 6 Single-Use Prefilled Pens, 

Crohn's Disease Starter Package, Rx Only, NDC #0074-4339-06. Cardinal Item #3946522. 


153) HUMIRA (adalimumab) Syringe, 40MG/0.8ML 2 Single-Use Prefilled Syringes (2), 

40mg/0.8mL, For Subcutaeoous Use Only, Rx only, NDC #0074-3799-02. Cardinal Item 


154) INFERGEN (Interferon alfacon-1), A recombinant consensus alpha interferon, For 

Subcutaneous Use Only, 15MCG/0.5ML 6X0.5ML, Single-Use Vials, Rx only, NDC #0187- 


155) INFERGEN (Interferon alfacon-1), A recombinant consensus alpha interferon, For 

Subcutaneous Use Only, 9MCG/0.3ML 6X0.3ML, Single-Use Vials, Rx only, NDC #0187- 


156) INTRON A (Interferon Alfa-2b, recombinant) Solution for Injection 10MMU/0.2ML 

1.5ML, Multidose Pen, For Subcutaneous Use, Rx only, NDC #0085-1254-01. Cardinal Item 


157) INTRON A (Interferon Alfa-2b, recombinant) Solution for Injection, 25 million IU 

multidose vial, 5 million IU/0.5 mL, For Intramuscular/Subcutaneous Use. Rx only, Schering, 


29

158) INTRON A (Interferon Alfa-2b, recombinant) Solution for Injection 6MMU/ML 3.8ML, 

Multidose vial, For Intramuscular/Subcutaneous Use. Rx only, NDC #0085-1168-01. Cardinal 


159) Interferon Alfa-2b, recombinant 10MMU 1 Vial with Diluent, Rx only, NDC #0085-0571- 


160) KINERET (anakinra), 100MG/0.67ML 28X0.67ML, Single Use Prefilled Glass Syringes 

with 27 Gauge Needles, Rx Only, NDC #55513-177-28. Cardinal Item #3552437. Recall # D- 


161) LACTINEX" (Lactobacillus) (Granules/Dietary Supplement), 12X1GM, OTC, Becton 

Dickinson Microbiology System, NDC #8290-2367-12. Cardinal Item #1116938. Recall # D- 


162) LACTINEX" 50, (Lactobacillus), OTC, Becton Dickinson Microbiology System, NDC 


163) AMGEN NEULASTA (PEGFILGRASTIM), Pegylated Recombinant Methionyl Human 

Granulocyte Colony Stimulating Factor (PEG-r-metHuG-CSF) derived from Ecoli, 6MG/0.6ML 

0.6ML, Single Use Prefilled Syringe, For Subcutaneous Use Only, Sterile Solution, Rx Only, 


164) PROCRIT (EPOETIN ALFA) Sterile Solution for Injection, For Intravenous or 

Subcutaneous Use Only, 10MU/ML 25X1ML Vials, Rx Only, NDC #59676-310-02. Cardinal 


165) PROSTIN VR PEDIATRIC (alprostadil injection, USP). 5X1ML Ampoules, Rx only, NDC 


166) PULMOZYME Inhalation Solution, (Dornase Alfa), 1MG/ML, as 30 X 2.5ML Ampules, 


167) REOPRO Solution, (ABCIXIMAB), 2MG/ML 5ML Vial, Rx only, NDC #0002-7140-01. 


168) RITUXAN (Rituximab) Injection, 10MG/ML Vial, 10ML Vial, For Intravenous Use, Rx 


169) VECTIBIX (panitumumab), SINGLE USE VIAL INJECTION 20MG/ML 10ML, Rx only, 


170) VECTIBIX (panitumumab), Single Use Vial 20MG/ML 20ML, Rx only, NDC #55513- 


171) VECTIBIX (panitumumab), Single Use Vial Injection 20MG/ML 5ML, Rx only, NDC 


30

172) XIGRIS (Drotrecogin alfa, activated), 1 x 5MG Vial, For Intravenous Use, Rx only, NDC 


173) XIGRIS (Drotrecogin alfa, activated), 1 x 20MG Vial, Rx only, Eli Lilly, NDC #0002- 

7561-01. Cardinal Item #3310174. Recall # D-313-2010 

CODE 

1) Lot #146044F; 

2) Lot #7N211, 8A206, and 31301422B; 

3) Lot #0427A1AA, 042792AA, 042793AA, 0427A7AA, 04791AA, 047291AA, 0427A1AA, 

0427A6AA, 042801AA, 042793AA, 042802AA, 0427A7AA and 042795AA; 

4) Lot #HD10158, HD012G8 and HD012G8; 

5) Lot #HD011F8 and HD012G8; 

6) Lot #7U7AB; 

7) Lot # A28650; 

8) Lot #22074A; 

9) Lot #470U020, 40U020, 40U036, 40U041, 40U299, 40U047 and 40U064; 

10) Lot #40U109 and 40U113; 

11) Lot #501247G, 559403AB, 559405AM, 743080S, 769584N and 795052B; 

12) Lot #PF2001 and PL2399; 

13) Lot # P32058, P32059, P32060, P32061, P32062 and P32064; 

14) Lot #ZE7BS, AM7BS, ZM7BS, ZM7B2 and 388BS; 

15) Lot #057BS, 0A7BS, 0R7BS and 0M7BS; 

16) Lot #0APPY, 0APYY and 0ARJW; 

17) Lot #203489, 203594, 203610, 203617, 203531, 203552, 203599, 203639 and 203667; 

18) Lot #7D622; 

19) Lot #31301824A and 31301824B; 

20) Lot #31301594B and 31301971B; 

21) Lot #0563X, 1109X, 1236X, 0943X, 0944X and 0710X; 

31

22) Lot #0986X, 1310X, 1077X, 1108X and 1239X; 

23) Lot #OAPF2 and OAWFP; 

24) Lot #68225EV, 64293EV and 61117EV; 

25) Lot #62133EV and 68226EV; 

26) Lot #42320A and 42309A; 

27) Lot #41995A, 42085A, 42166A and 42196A; 

28) Lot #202899; 

29) Lot #63-386-DJ; 

30) Lot # WC07120 and WC08007; 

31) Lot #085832, 082856 and 084983; 

32) Lot #084613, 083650, 084612, 085053 and 084970; 

33) Lot #337651, 307331 and 317601; 

34) Lot #59350DD and 59355DD; 

35) Lot #8B104, 31302138B and 31302276B; 

36) Lot #7P125 and 8B109; 

37) Lot #68415DD and 63545DD; 

38) Lot #63540DD; 

39) Lot #080974B; 

40) Lot #0812820, 0228412, 0806981 and 0728412; 

41) Lot #2719, 2786, 2756, 2827, 2995, 2996 and 2907; 

42) Lot #2771, 2775, 2814, 2844, 2685, 2788, 2829, 2846, 2882, 2953, 3185, 2955, 3026 and 

3097; 

43) Lot #2905; 

44) Lot #2794; 

45) Lot # F687A and H946A; 

32

46) Lot # 0403X; 

47) Lot #1199426; 

48) Lot #7P621, 7E635 and 7C635; 

49) Lot #7S618; 

50) Lot #S0176B; 

51) Lot #S0165A, S0166A, S0167 and S0167A; 

52) Lot #A401759K, A404808A and A409327A; 

53) Lot # DH10009; 

54) Lot # 701100; 

55) Lot #1254572; 

56) Lot #1254576; 

57) Lot # 63198EV; 

58) Lot #64174EV, 65199EV; 

59) Lot #7H114 and 31301344B; 

60) Lot #7H112, 7H113 and 3130285B; 

61) Lot #404281; 

62) Lot # A491801C; 

63) Lot # A431046D; 

64) Lot # A402933A, A409591E, A402932C and A425646F; 

65) Lot #31430860B and 31300860B; 

66) Lot #7N619 and 31302398B; 

67) Lot #800716 and 807012; 

68) Lot # NN0014, NN0048, NP0103, NP0105, NP0106, NP0108, PB0011, PB0013, PB0014, 

PH0061, PH0062, PH0063, PN0089, 8134A and 8135A; 

69) Lot #8017A, 8033A, 8018A, 8021A, 8032A, 8033A, 8132A and 8133A; 

33

70) Lot # A33755C, A35570B, A35570C, A33374C and A33374B; 

71) Lot #8029A and 8030A; 

72) Lot # PF0136; 

73) Lot #488GA, 3K8GA and AK8GA; 

74) Lot #448GV and 8P7GV; 

75) Lot #08D010B; 

76) Lot #0L7GA; 

77) Lot #VU60265, VU60665, TU60771, TU61145, TU60980, TU61145, TU61509, VU60382 

and VU60464; 

78) Lot # TU60705, TU61110, TU61501 and VU60407; 

79) Lot # TC70791, TC70601, TC70826, TC70741, TC70716, TC70689, TC70770 and 

TC70734; 

80) Lot # TC70842, TC70599, TC70631, TC70812, TC70687, TC70715, TC70740, TC70732, 

TC70735, TC70686; 

81) Lot #5R8A; 

82) Lot #1178517, 1242233 and 130560 

83) Lot #1330801; 

84) Lot #1316434; 

85) Lot #31300725B, 31301329B and 8A210; 

86) Lot #641782E21, 624762E22, 641752E21, 624802E24, 641872E21, 641882E21 and 

656962E22; 

87) Lot # S0002, S0007, S0072, 51556791, 51557445, 51557991, 51556103, 51556101, 

51558539, 51559166, 51559362, 51559589, 51557943, 51558866, 51558806, 51560116 and 

51561372; 

88) Lot #51558457; 

89) Lot #Y10B9754, Y10B7223 and Y10B3795; 

90) Lot #814040, 813040, 812040, 811040 and 810040; 

34

91) Lot # R8032A and R8042A; 

92) Lot # H06108B, H06058B and H06098B; 

93) Lot #63709Z7and 63819Z7; 

94) Lot #63820Z7; 

95) Lot #8A067, 8A066, 8B171, 8B170, 8A065 and 8A064; 

96) Lot #91507 and 81227; 

97) Lot #50810440; 

98) Lot #P00005AB; 

99) Lot #137683F; 

100) Lot #8245902, 0135K08A, 8245902 and 0240K08A; 

101) Lot #7L625; 

102) Lot #31300738B; 

103) Lot #7N623; 

104) Lot #7N624P1; 

105) Lot #46699; 

106) Lot # W0004736, W0004709, W0004693, W0004610, W0004608, W0004577, W0004576, 

W0004574, W0004552, W0004545, W0004538, W0005437, W0004540,W0004519, 

W0004518, W0004517, W0004506, W0004504, W0004495, W0004493, W0004491, 

W0004477, W0004475 and W0004461; 

107) Lot #7E610, 6N601, 8B604 and 31301012B; 

108) Lot number: 71904298 and 71103258; 

109) Lot number: 70503048, 71204018 and 72506248; 

110) Lot number: 08P013A; 

111) Lot numbers: 641782E21, 624762E22, 641752E21, 624802E24, 641872E21, 641882E21, 

656962E22; 

112) Lot numbers: 63490DD; 

35

113) Lot numbers: 63305DD; 

114) Lot numbers: 62025DD, 62420DD and 64340DD; 

115) Lot #-27007; 

116) Lot #P27005 and 27004; 

117) Lot #P113561; 

118) Lot #P115744 and 1006259; 

119) Lot #P104612, P097880 and 1007217; 

120) Lot #P115737; 

121) Lot #P097881and P102341; 

122) Lot # P115757; 

123) Lot #P104613; 

124) Lot #1007780 and P122921; 

125) Lot #1001038; 

126) Lot #1001001; 

127) Lot #P104599; 

128) Lot #P107119; 

129) Lot #-113562 and 1005205; 

130) Lot #P102536 and 1006257; 

131) Lot #P107113 and P122925; 

132) Lot #P115733; 

133) Lot #P122923, P122924 and 1005192; 

134) Lot #716263, 717231, 717232, 728878, 728879, 728881and 739030; 

135) Lot #706437, 708781, 706439, 735153, 737522 and 740494; 

136) Lot #P011116, P01114 and P01117; 

36

137) Lot #717230, 723332, 723340, 723411, 708807 and 723411; 

138) Unknown 

139) Lot # P115908, P118867, P11867, P118868, P118869, P118870, P11870, P118871, 

1005248 and P118872; 

140) Lot #D108961, D114429, D119037, D127514, and D127517; 

141) Lot #1006138 and 106229; 

142) Lot #P045101, P109306, P109307, P115705, P115706 and P115709; 

143) Lot #P113702, P113701, P122570; 

144) Lot #P113681, P113638, P113639, P113680and P113640; 

145) Lot #P113705 and 122558; 

146) Lot #P102165, P113147 and P122524; 

147) Lot #P118859, P124804, 1005265; 

148) Lot P069760 and P095191; 

149) Lot #P122567, P122568, P122635, 1005232 and 1005233; 

150) Lot #722385, 724365, 724370, 724370, N73218 and 725428; 

151) Lot #61141SP40, 61141SP40, 611399A40, 60129LJ40, 61141SP40, 611429A41, 

62149LJ40, 62146LJ40, 611389A40, 58106LX41, 60131LJ40, 611429A41, 68106LX41, 

611389A40, 63168LJ40, 62146LJ40, 62149LJ40, 61141SP40, 611399A40, 68106LX41, 

60131LJ40, 60131LJ, 59118LX40, 60132LJ40, 59118LX40, 60129LJ40, 60132LJ40, 

61141SP40 and 60131LJ; 

152) Lot #64188SP, 58105LX, 58105LX and 64188SP; 

153) Lot #56078LX41, 56079LX41, 59120LX40, 62161LJ40, 641779A40, 64181SP40, 

64184SP40, 591129A40, 64179SP40, 64170SP40, 641795P, 64179SP; 

154) Lot # P094914 and P083996; 

155) Lot # P115874; 

156) Lot #8 CO 3001, 8 CO 3002, 8 CO 3003, 8 CO 3004 and 8 CO 2001; 

157) Lot #7IOT404; 

37

158) Lot #7IOQ403; 

159) Lot #8CO201 and 8CO202; 

160) Lot # P086263 and P084061; 

161) Lot #8205508, 8140483, 8163945 and 8197372; 

162) Lot #8217097, 8148202, 8168255 and 8182430; 

163) Lot # P113628, P113629, P104493, P107037, P137107 and P107038; 

164) Lot # D121439A, D091540A, D091536A and D091538A; 

165) Lot #0AMRY; 

166) Lot #707783, 704788, 704789, 705949, 705997 and 706758; 

167) Lot #06L13AA and 07A04AA; 

168) Lot #705394, 719292, 737039 and 737040; 

169) Lot #1007223, D103289, D080740 and D080739; 

170) Lot # D100364, D103342, D096222 and D096223; 

171) Lot #1007223, 1008047, D081366, D094109, and D103289; 

172) Lot # A36171, A34507; 

173) Lot # A25690, A26979 


Recalling Firm: Cardinal Health Care, McDonough, GA, by telephone beginning November 6, 

2008 and letters on November 13, 2008. 

Manufacturer: Gilead Sciences Inc., San Dimas, CA. Firm initiated recall is complete. 

REASON 

Temperature abuse; Product stability may have been compromised due to defective refrigeration 

storage unit. 


Approximately 11,000 packages/units 

DISTRIBUTION 

AL, GA, MO, MS, SC, TN and WV 


Irinotecan Hydrochloride Injection, 20 mg/mL, 2mL Vial (NDC 0781-3066-72), 5mL Vials 

(NDC 0781-3066-75), Rx only. Recall # D-314-2010 

CODE 

All lots 


38

Sandoz Inc., Broomfield, CO, by letter on December 18, 2009. Firm initiated recall is ongoing. 

REASON 

Marketed without an approved NDA/ANDA: Data from foreign drug development center could 

not be substantiated. 


83,872 Vials 

DISTRIBUTION 

Nationwide 


1) D-17 Tumorell Homeopathic Formula, 1 fl. oz., NDC 58264-0017-1. Recall # D-315-2010; 

2) D-24 Pneumell Homeopathic Formula, 1 fl. oz., NDC 58264-0024-1. Recall # D-316-2010; 

3) D-33 Spasmonell, Homeopathic Formula, 1 fl. oz., NDC 58264-0033-1. Recall # D-317-2010; 

4) D-40 PERANEMIOL Homeopathic Formula, 1 fl. oz., NDC 58264-0040-1. Recall # D-318- 


5) D-46 Goutinol Homeopathic Formula, 1 fl. oz., NDC 58264-0046-1. Recall # D-319-2010; 

6) D-48 Pulmonon Homeopathic Formula, 1 fl. oz., NDC 58264-0048-1. Recall # D-320-2010; 

7) D-62 Rubilin Homeopathic Formula, 1 fl. oz., NDC 58264-0062-1. Recall # D-321-2010 

CODE 

1) Lot numbers: 0713, 1013, 0112-81, 0212-62, 0412-94, 0512-117, and 0712-112; 

2) Lot number: 0313; 

3) Lot numbers: 0213, 0713, and 0112-110; 

4) Lot numbers: 0913 and 1012-123; 

5) Lot numbers: 1113-55 and 0712-169; 

6) Lot numbers: 0213, 0813, 1213-35, and 0812-41; 

7) Lot numbers: 0712-117. BREAKDOWN OF CODE: First 4 numbers indicate month of mfr 

and the 3 year expiration date; the numbers after the dash are assigned in sequence throughout 

the month. Example: 0172-112, the product was the 112th product manufactured during the 

month of July, 2009. Before November 2008 lot numbers consisted of month of manufacture and 

a 5 year expiration date. Example: Lot 1013 the product was made in the 10th month of 2008 


Dynamic Nutritional Associates, Chelan, WA, by letters on November 11, 2009 and December 

16, 2009. Firm initiated recall is ongoing. 

REASON 

Unapproved Drug; products labeled as over the counter homeopathic drugs, however are labeled 

with drug claims. 


1,795 units (each unit is a 1 fl oz bottle) 

DISTRIBUTION 

Nationwide 


Shopko Cold/Flu Relief multi-symptom day time, Nasal Decongestant, Cough Suppressant Pain 

39

Reliever Reducer, Pseudoephedrine Free, 10 fl oz. (295 mL). Also packaged under the name: 

Market Basket Non-Drowsy Day-Time Alcohol Free Antihistamine Free Multi Symptom 

Cold/Flu Relief, UPC: 0-49705-74017-0- Market Basket UPC: 4-00064-53344-3 – ShopKo. 

Recall # D-322-2010 

CODE 

Lot number 4046, Exp 3/2011; 4118, Exp 7/2011; and 4132, Exp. 9/2011 


IGA Inc., Buena, NJ, by letters on December 16, 2009. Firm initiated recall is ongoing. 

REASON 

Sub-potent; dextromethorphan Hbr 


20,544 10 oz bottles 

DISTRIBUTION 

Nationwide 


1) Milk of Magnesia Mint Flavor saline laxative packed in 12 oz and 26 oz bottles, OTC. 

Packaged under the following labels: CVS Milk of Magnesia, NDC 59779-332-40, and 59779- 

332-35; Equaline Milk of Magnesia fresh mint, NDC 41163-322-40, 41163-332-35; Good 

Neighbor Pharmacy Milk of Magnesia Saline Laxative Fresh Mint, NDC 24385-332-40; Good 

Sense Milk Of Magnesia Fresh Mint, NDC 0113-0332-40; Hannaford Milk of Magnesia Mint 

Flavor, NDC 41268-332-40; HyVee Milk of Magnesia Mint Flavor, NDC 42507-332-40; Kroger 

Milk of Magnesia Mint Flavor, NDC 30142-332-40; Leader Milk of Magnesia Mint, NDC 

37205-834-40; The Medicine Shoppe Milk of Magnesia Mint Flavor, NDC 49614-332-40; 

Meijer Milk of Magnesia Mint Flavor, NDC 41250-332-40, 41250-332-35; Publix Milk of 

Magnesia Mint, NDC, 56062-332-40; Safeway Mint Flavor Milk of Magnesia, NDC 21130-332- 

40; Sun Mark Milk of Magnesia Mint Flavor, NDC 49438-688-44, 49348-688-39; TopCare Milk 

Of Magnesia Mint Flavor, NDC 36800-332-40; Western Family Milk of Magnesia Fresh Mint, 

NDC 55313-332-40, Expiration dates from 11/2011 through 9/2012. Recall # D-323-2010; 

2) Milk of Magnesia Original saline laxative in 12 oz bottles. Packed under the following labels: 

CVS Milk of Magnesia, NDC 59779-396-40; Equaline Milk of Magnesia, NDC 41163-396-40; 

GoodSense Milk of Magnesia, NDC 0113-0396-40; Good Neighbor Pharmacy Milk of 

Magnesia, NDC 24385-396-40; Hannaford Milk of Magnesia, NDC 41268-396-40; Healthy 

Accents Milk of Magnesia DZA Brands, NDC 55316-396-40; HyVee Milk of Magnesia, NDC 

42507-396-40; Kroger Milk of Magnesia, NDC 30142-396-40; Leader Milk of Magnesia, NDC 

37205-883-40; The Medicine Shoppe Milk of Magnesia, NDC 49614-339-40; Publix Milk of 

Magnesia, NDC 56062-396-40; Sunmark Milk of Magnesia, NDC 49348-687-39; TopCare Milk 

of Magnesia, NDC 36800-396-40; Western Family Milk of Magnesia, NDC 5531--396-40. 

Expirations from 11/2011 through 9/2012. Recall # D-324-2010 

CODE 

1) 9CK0061, 9CK0234, 9CK0408, 9CK0508, 9CK0655, 9DK0072, 9DK0211, 9DK0377, 

9DK0388, 9DK0513, 9DK0629, 9EK0025, 9EK0129, 9EK0174, 9EK0405, 9EK0421, 

9EK0466, 9EK0528, 9EK0539, 9FK0046, 9FK0066, 9FK0257, 9FK0272, 9FK0427, 9FK0443, 

9FK0522, 9FK0632, 9FK0633, 9FK0695, 9GK0050, 9GK0056, 9GK0309, 9GK0321, 

9GK0438, 9GK0532, 9GK0669, 9GK0675, 9HK0107, 9HK0286, 9HK0314, 9HK0375, 

9HK0390, 9HK0532, 9HK0610, 9HK0673, 9JK0125, 9JK0167, 9JK0265, 9JK0543, 9JK0592, 

9KK0083, 9KK0095, 9KK0311, 9LL0432, 9KK0534, 9KK0592, 9LK0003, 9LK0027, 

9LK0154, 9LK0313, and 9LK0396. Milk of Magnesia original flavor 9CK0653, 9DK0071, 

40

9DK0209, 9DK0375, 9DK0511, 9EK0023, 9EK0172 9EK0407, 9EK0524, 9FK0042, 9FK0254, 

9FK0255, 9FK0424, 9FK0520, 9FK0693, 9GK0048, 9GK0307, 9GK0435, 9GK0667, 

9HK0105, 9HK0284, 9HK0374, 9HK0531, 9HK0672 9JK0123, 9JK0183, 9JK0241, 9JK0378, 

9JK0540, 9KK0080 and 9DKK0545; 

2) Milk of Magnesia original flavor 9CK0653, 9DK0071, 9DK0209, 9DK0375, 9DK0511, 

9EK0023, 9EK0172 9EK0407, 9EK0524, 9FK0042, 9FK0254, 9FK0255, 9FK0424, 9FK0520, 

9FK0693, 9GK0048, 9GK0307, 9GK0435, 9GK0667, 9HK0105, 9HK0284, 9HK0374, 

9HK0531, 9HK0672 9JK0123, 9JK0183, 9JK0241, 9JK0378, 9JK0540, 9KK0080 and 

9DKK0545 


L. Perrigo Co., Allegan, MI, by letter dated April 15, 2009. Firm initiated recall is ongoing. 

REASON 

Misbranded; the amount of calcium and magnesium per tablespoon are understated in the "Other 

information" box on the Drug Facts statement (magnesium content is listed as 160mg/15ml when 

it should be listed as of 520mg/15ml; the calcium content is listed as 5mg/15ml instead of 

20mg/15ml). 


397,800 bottles of mint flavor; 324,876 bottles of original flavor 

DISTRIBUTION 

Nationwide 


1) Formo Cresol Solution, Contains Formaldehyde - 48.5%, Cresol, 48.5%, 1 fl oz (30 mL), Rx 

only, For Dental Use. a) Sultan, Ref # 0010601FG --- b) Henry Schien, Model # 1710601FG --- 

c) Henry Schien Model number CN10601FG --- d) Super Dent, Model # 14106011A. Recall # 

D-325-2010; 

2) Dry Socket Remedy contains Benzocaine, Guaiacol and Balsam Peru, 1.Fl oz (30ml), Rx 

only, For Dental Use Only. Recall # D-326-2010 

CODE 

1) a) Lot numbers: 090925909, 110925952, 0111090122, 0111090130, 0311090319, 

0311090321, 0411090421, 0610080614, 0610080616, 0610080617, 1010081024, 1110081113, 

1210081209, 04110904211, 07100807031, 08100808141, 08110908131, 10100810242; b) lot 

numbers: 090925908, 090925909, 0311090321, 0810080813, 0810080814, 0811090810, 

0811090813, 1110081112, 03110903191, 031109030201, 08110908101, 10100810241, 

11100811121; c) Lot numbers: 110925952, 0710080703; d) Lot numbers: 090925908, 

0311090320, 0811090813, and 1110081113; 

2) Lot numbers: 0110090109; 0110090112; 01100901121; all expire January 2010 


DSHealthcare Inc. dba Sultan Health Care, Hackensack, NJ, by telephone/e-mail on September 

30, 2009 and by letters beginning on October 9, 2009. 

Manufacturer: Dentsply Caulk, Milford, DE. Firm initiated recall is ongoing. 

REASON 

Subpotent: During 12-month stability testing point the products failed to meet their specifications 

for active ingredients. 


1) 48,477; 2) 272 

41

DISTRIBUTION 

Nationwide 


Antibacterial Washcloths (Benzalkonium chloride) 0.115%, 25-count cloths per can. UPC 

50428-16554. Made in China. Recall # D-328-2010 

CODE 

Lot number (on bottom of plastic can): 09234A, 09236C, 09237B, 09238C 


Recalling Firm: Rockline Industries, Sheboygan, WI, by e-mail and telephone on December 7, 

2009. 

Manufacturer: Soshio Wet Tissue Co., Ltd., ShunDe, FoShan, China. Firm initiated recall is 

ongoing. 

REASON 

Subpotent (Single Ingredient) Drug: Rockline Industries is recalling antibacterial washcloths, 25- 

count, sold exclusively at CVS Pharmacy because it is subpotent and does not have an expiration 

date. 


97,485 cans 

DISTRIBUTION 

Nationwide 

Current Drug Shortages 

Ferrous Sulfate Oral Tablets 

December 3, 2009 

Products Affected – Description: 

Ferrous Sulfate Tablets, Amneal 

325 mg tablets, 1000 count (NDC 65162-0406-11) – discontinued 

Ferrous Sulfate Tablets, Consolidated Midland 



Ferrous Sulfate Tablets, Marlex 

324 mg tablets, unit dose, red, 100 count (NDC 10135-0242-13) 



325 mg tablets, unit dose, green, 100 count (NDC 10135-0243-13) 

325 mg tablets, unit dose, green, 1000 count (NDC 10135-0243-19) 

Ferrous Sulfate Tablets, Teva 

325 mg tablets, green, 1000 count (NDC 00182-4028-10) 

325 mg tablets, red, enteric coated, 100 count (NDC 00182-4030-10) – discontinued 

Reason for the Shortage: 

Manufacturers are stating there is a raw material shortage. Manufacturers located in Beijing, 

China were shut down during the summer Olympics and are now attempting to resupply product 

42

and falling short of demand. Consolidated Midlands has discontinued all of their ferrous sulfate 

presentations. Amneal has discontinued their ferrous sulfate product. 

Article link: http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/ 

DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=499 

Source website: http://www.ashp.org 

Pentazocine/Naloxone Tablets 


Drug Shortage 


Talwin NX tablets, 100-count (NDC 00024-1951-04), Sanofi-Aventis- discontinued 

Pentazocine/Naloxone tablets 50 mg/0.5 mg, 100-count (NDC 52152-0211-02), Actavis 

Pentazocine/Naloxone tablets 50 mg/0.5 mg, 500-count (NDC 52152-0211-04), Actavis 

Reason for the Shortage: Actavis voluntarily recalled their pentazocine/naloxone tablets, along 

with all other prescription products manufactured at their Little Falls, NJ facility. The recall 

came in response to an FDA inspection of the manufacturing site. More information is available 

about the recall at http://www.actavis.us/en/media+center/newsroom/articles/ 

Actavis+Totowa+Recall.htm. Sanofi-Aventis recently discontinued their Talwin NX tablets. 

Watson was allocating product to wholesalers. 




Amphetamine 



Amphetamine mixed salts extended release capsules, Teva 

5 mg capsules, 100 count (NDC 00555-0790-02) 







Teva has their product on back order due to problems obtaining raw materials. 




Methoxsalen Capsules and Lotion 



Oxsoralen, 1% topical lotion (NDC 00187-0402-31), Valeant 

Oxsoralen Ultra, 10 mg capsules (NDC 00187-0650-42), Valeant 


Valeant states the shortage is due to a raw materials shortage. 




43

Isradipine Capsules and Extended-Release Tablets 



Isradipine, Actavis 

2.5 mg capsules, 60 count (NDC 52152-0263-01) 

2.5 mg capsules, 100 count (NDC 67767-0108-01)- discontinued 


5 mg capsules, 100 count (NDC 67767-0109-01) - discontinued 


GlaxoSmithKline acquired Dynacirc CR from Reliant. The product had been unavailable during 

this transition. Actavis has discontinued isradipine 2.5 mg and 5 mg capsules in 100 count size. 




Ondansetron 



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 

2 mL vials, packages of 10 (NDC 55390-0121-10) 

2 mL Novaplus vials, packages of 10 (NDC 55390-0307-10) 

Ondansetron injection, 2 mg/mL, Cura 


Ondansetron injection, 2 mg/mL, Hospira 

2 mL syringes (NDC 00409-1120-62) 

Ondansetron injection, 2 mg/mL, Teva 



Multiple manufacturers have their ondansetron single dose vials on back order. Manufacturers 

will not provide a reason for this shortage. Apotex has discontinued their ondansetron injection. 

Baxter has discontinued their ondansetron injection 1 mL vial. The company could not provide a 

reason for the discontinuation. 




Esterified Estrogens and Methyltestosterone Tablets 



Esterified Estrogens 1.25 mg and Methyltestosterone 2.5 mg Tablets 

Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 51991-0079-01), Breckenridge 

Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 53746-0078-01), Amneal 

Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 68462-0173-01), Glenmark 

44

Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 00527-1410-01), Lannett 

Covaryx, 100 count bottles (NDC 11528-0010-01), Centrix 

EEMT, 100 count bottles (NDC 15310-0010-01), Creekwood Pharma 

Esterified Estrogens 0.625 mg and Methyltestosterone 1.25 mg Tablets 

Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 51991-0078-01), 

Breckenridge 

Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 53746-0077-01), Amneal 

Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 68462-0174-01), Glenmark 

Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 00527-1409-01), Lannett 


Centrix and Breckenridge products were in short supply due to a raw material shortage. 

Amneal was unable to provide a reason for the shortage. 

Glenmark and Lannett are unable to provide a reason for the shortage. 

Prasco Labs discontinued Essian and Essian HS in May, 2009. 

Solvay discontinued Estratest and Estratest HS in March, 2009. 




Alprostadil Products 



Alprostadil 0.5 mg/mL injection, Bedford 

1 mL ampule (NDC 55390-0506-10) 

1 mL ampule, Novaplus (NDC 55390-0503-10) 

Caverject injection, Pfizer 

10 mcg powder for injection, package of 6 (NDC 00009-3778-05) - discontinued 

20 mcg/mL solution for injection, 2 mL vial, package of 5 (NDC 00009-7650-02) – 

discontinued 

Caverject Impulse injection cartridges, Pfizer 

10 mcg cartridge, package of 2 (NDC 00009-5181-01) 

20 mcg cartridge, package of 2 (NDC 00009-5182-01) 

Muse urethral suppositories, Vivus 

125 mcg suppository (NDC 62541-0110-01) - discontinued 

125 mcg suppository, package of 6 (NDC 62541-0110-06) - discontinued 

Reason for the Shortage: Bedford’s product is not available. The company has temporarily 

suspended manufacturing and distribution of all products while investigating a potential crosscontamination 

issue. Bedford estimates the suspension may be lifted by the end of July, 2009, 

but cannot estimate when product will be available. Teva’s product was on back order due to 

manufacturing difficulties. Pfizer’s Caverject Impulse is on back order while the product is 

reformulated. The company has discontinued Caverject injection 10 mcg lyophilized powder and 

20 mcg/mL solution for injection. Prostin VR Pediatric was on back order for unknown reasons. 

Schwarz could not meet demand for product. Vivus has discontinued Muse 125 mcg urethral 

suppositories. 



45


Morphine Sulfate Oral Concentrated Solution 

January 4, 2010 


Morphine sulfate concentrated oral solution, 20 mg/mL, Ethex 

30 mL bottle (NDC 58177-0886-01) - discontinued 



0.25 mL unit dose, package of 30 (NDC 58177-0888-80) - discontinued 

0.50 mL unit dose, package of 30 (NDC 58177-0889-81) - discontinued 

1 mL unit dose Inveamp, package of 30 (NDC 58177-0886-56) - discontinued 

15 mL bottle with dropper (NDC 58177-08886-57) – discontinued 

Morphine sulfate concentrated oral solution, 20 mg/mL, Mallinckrodt 

15mL bottle with syringe (NDC 00406-8003-15) 

15 mL bottle, package of 6 (NDC 00406-0830-15) - discontinued 


120 mL bottle with syringe (NDC 00406-8003-12) 


240 mL bottle with spoon (NDC 00406-8003-24) 


Roxanol, 20 mg/mL, Xanodyne 





FDA sent warning letters in late-March, 2009 to several suppliers of unapproved narcotics. 

These companies have until May 29, 2009 to stop manufacturing new product and distributors 

have until June 28, 2009 to stop shipping product. The following link provides detailed 

information on the unapproved products http://www.fda.gov/cder/drug/ 

unapproveddrugs/enforcement.htm#narcotics. In December, 2008, KV Pharmaceuticals, which 

markets prescription medications through Ethex, voluntarily suspended shipment of all 

prescription tablet products. 

(http://www.kvpharmaceutical.com/news_center_article.aspx?articleid=276). In early 2009, 

FDA filed an injunction against KV Pharmaceuticals preventing the company from 

manufacturing any products until all issues are resolved. Lannett states the shortage is due to 

increased demand for the product. Mallinckrodt states they are working with the FDA to resolve 

the shortage situation. Glenmark states the shortage is due to increased demand for the product. 

Xanodyne has discontinued all presentations of Roxanol 20 mg/mL solution. 




Colchicine Tablets 



Colchicine tablets, Excellium 

0.6 mg, 100 count (NDC 64125-0104-01) 

0.6 mg, 1000 count (NDC 64125-0104-10) 

46

Colchicine tablets, Vision Pharma 

0.6 mg, 500 count (NDC 68013-0001-05) 

0.6 mg, 1000 count (NDC 68013-0001-10) 

Colchicine tablets, Westward 

0.6 mg, 100 count unit dose (NDC 00143-1201-25) 


Excellium has their colchicine tablets on shortage for legal reasons. 

Vision could not provide a reason for their shortage 




Cocaine Topical Solution 



Cocaine topical solution, 100 mg/mL, Roxane 

4 mL vial (NDC 00054-8164-02) - discontinued 


Cocaine topical solution, 40 mg/mL, Roxane 


10 mL vial (NDC 00054-3154-40) – discontinued 

Cocaine topical solution, 100 mg/mL, Lannett 

4 mL vial (NDC 00527-1729-74) 

10 mL vial (NDC 00527-1729-73) 

Cocaine topical solution, 40 mg/mL, Lannett 

4 mL vial (NDC 00527-1728-74) 

10 mL vial (NDC 00527-1728-73) 


Roxane states the 4% cocaine topical solution has been discontinued and could not provide a 

reason. The company discontinued the 10% solution in October, 2007. 




Acyclovir Capsules and Tablets 



Acyclovir capsules and tablets, Apotex 


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




Zovirax capsules and tablets, GSK 


Acyclovir capsules and tablets, Major 

200 mg capsules, 100 count, unit dose (NDC 00904-5789-61) 

47

400 mg tablets, 100 count, unit dose (NDC 00904-5790-61) 


Acyclovir tablets, Mylan 

400 mg tablets, 100 count (NDC 00378-0253-01) - discontinued 


Acyclovir capsules and tablets, Ranbaxy 





Acyclovir capsules and tablets, Teva 










Acyclovir capsules and tablets, UDL 




Acyclovir capsules and tablets, Watson 




Apotex has halted manufacturing due to an FDA audit. 

Ranbaxy has an FDA import ban on several of their products manufactured in India. 

Major, Teva, GSK and UDL could not provide a reason for the shortage. 

Mylan and Watson have discontinued their acyclovir tablets. The companies could not provide a 

reason for this discontinuation. 




Nicardipine 



Nicardipine hydrochloride injection, 2.5 mg/mL, 10 mL vials (NDC 00703-8315-03), Teva 


Teva recalled 4 lots nicardipine injection because the product did not meet impurity 

specifications. The recalled lots are 31302508B, 31302510B, 31302957B, 31303195B. Teva 

48

cannot estimate when product will be available. Supplies of Cardene are available from EKR 

Therapeutics in either ampules or a premixed solution. 




Gemfibrozil Tablets 



Gemfibrozil 600 mg tablets, Apotex 

60 count (NDC 60505-0034-04) 

100 count (NDC 60505-0034-01) 

100 count, unit dose (NDC 60505-0034-00) 

200 count (NDC 60505-0034-02) 

500 count (NDC 60505-0034-08) 

2500 count (NDC 60505-0034-06) 

Gemfibrozil 600 mg tablets, Blu 

60 count (NDC 24658-0130-60) 

180 count (NDC 24658-0130-18) 

500 count (NDC 24658-0130-05) 

Gemfibrozil 600 mg tablets, Camber 

60 count (NDC 31722-0225-60) 

500 count (NDC 31722-0225-05) 

Gemfibrozil 600 mg tablets, Major 

60 count (NDC 00904-5379-52) 


500 count (NDC 00904-5379-40) 

Gemfibrozil 600 mg tablets, Teva 

60 count (NDC 00093-0670-06) 

500 count (NDC 00093-0670-05) 

Gemfibrozil 600 mg tablets, UDL 

25 count robot-ready packaging (NDC 51079-0787-19) 

Lopid 600 mg tablets, Pfizer 

60 count (NDC 00071-0737-20) 

500 count (NDC 00071-0737-30) 


Apotex has an import ban on all of their solid formulations, including gemfibrozil tablets. 

Blu and Camber state the shortage is due to a raw materials shortage. 

Major, Pfizer, Teva, and UDL could not provide a reason for the shortage. 




Lorazepam 



Ativan 2 mg/mL, Baxter 


Lorazepam 2 mg/mL, Bedford 

49

1 mL vial (NDC 55390-0168-10) 

10 mL vial (NDC 55390-0170-10) 

Lorazepam 2 mg/mL, Hospira 

1 mL vial (NDC 00409-6778-02) 


Baxter states lorazepam 2 mg/mL injections are in short supply due to manufacturing delays. 

Baxter discontinued their Ativan 2 mg/mL 10 mL vial in April, 2009. 

Article link: 

http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/ 

GettingStarted/CurrentShortages/Bulletin.aspx?id=537 


Nitroglycerin Sublingual Tablets 



Nitroglycerin sublingual tablets, Glenmark 

0.3 mg tablets, 100 count (NDC 68462-0145-01) 



0.4 mg tablets, 100 count, unit dose (NDC 68462-0146-45) 


Nitroquick sublingual tablets, Ethex 

0.3 mg tablets, 100 count (NDC 58177-0323-04) - discontinued 


0.4 mg tablets, 100 count, unit dose (NDC 58177-0324-18) - discontinued 


Reason for the Shortage: Ethex discontinued all presentations of Nitroquick sublingual tablets in 

February, 2008. In early 2009, FDA filed an injunction against KV Pharmaceuticals preventing 

the company from manufacturing any products until all issues are resolved. Glenmark is 

experiencing supply and demand issues due to the discontinuation of Nitroquick by Ethex. 




Mexiletine Capsules 



Mexiletine capsules, Teva 





Teva could not provide a reason for the shortage. 

Teva is the only supplier of mexiletine capsules. Other manufacturers such as Sandoz, 

Boehringer Ingelheim, and Watson discontinued their mexiletine presentations. 




50

Metoprolol Tablets 



Metoprolol succinate extended release tablets, Ethex 

100 mg, 100 unit-dose (NDC 58177-0368-11) - discontinued 

100 mg, 100s (NDC 58177-0368-04) - discontinued 




Metoprolol succinate extended release tablets, Sandoz 

25 mg, 100s (NDC 00185-0281-01) 

25 mg, 1000s (NDC 00185-0281-10) 

50 mg, 100s (NDC 00185-0282-01) 

50 mg, 1000s (NDC 00185-0282-10) 

100 mg, 100s (NDC 00185-0283-01) 

100 mg, 1000s (NDC 00185-0283-10) 

200 mg, 100s (NDC 00185-0284-01) 

200 mg, 1000s (NDC 00185-0284-10) 

Metoprolol succinate extended release tablets, Watson 

25 mg, 100s (NDC 62037-0830-01) 

25 mg, 1000s (NDC 62037-0830-10) 

50 mg, 100s (NDC 62037-0831-01) 

50 mg, 1000s (NDC 62037-0831-10) 


In December 2008, KV Pharmaceuticals, which markets prescription medications through Ethex, 

voluntarily suspended shipment of all prescription tablet products. In early 2009, FDA filed an 

injunction against KV Pharmaceuticals preventing the company from manufacturing any 

products until all issues are resolved. Ethex has temporarily discontinued metoprolol extendedrelease 

tablets. Sandoz has metoprolol extended release tablets on back order due to a product 

recall in September 2008. Sandoz has metoprolol extended release tablets on back order due to a 

product recall in September 2008. Par’s metoprolol extended release tablets were in short supply 

due to increased demand. 




Belladonna Alkaloids with Phenobarbital 



Belladonna with Phenobarbital Elixir 

Donnatal elixir, 473 mL (NDC 66213-0423-16), PBM Pharmaceuticals 

Belladonna/phenobarbital elixir, 480 mL (NDC 00603-1030-58), Qualitest - discontinued 

Belladonna/phenobarbital elixir, 480 mL (NDC 00254-9035-58), Vintage – discontinued 

Belladonna with Phenobarbital Tablets 

Belladonna/phenobarbital tablets, 100 count (NDC 00603-2418-21), Qualitest - discontinued 

Belladonna/phenobarbital tablets, 1000 count (NDC 00603-2418-32), Qualitest - discontinued 

Belladonna/phenobarbital tablets, 100 count (NDC 00254-2320-28), Vintage - discontinued 

Belladonna/phenobarbital tablets, 1000 count (NDC 64125-0128-10), Excellium – discontinued 

51


PBM Pharmaceuticals could not provide a reason for the shortage. 

Qualitest, Vintage, and Excellium were unable to provide a reason for the discontinuation of 

their generic belladonna/phenobarbital products. 

Belladonna alkaloids with phenobarbital are not FDA-approved products. 




Pentoxifylline Tablets 



Pentoxifylline 400 mg tablets, Apotex 

100 count (NDC 60505-0033-06) 

500 count (NDC 60505-0033-07) 

5500 count (NDC 60505-0033-08) 

Pentoxifylline 400 mg tablets, Major 


Pentoxifylline 400 mg tablets, Mylan 

500 count (NDC 00378-0357-05) 

Pentoxifylline 400 mg tablets, Teva 

100 count (NDC 00093-5116-01) 

500 count (NDC 00093-5116-05) 

Pentoxifylline 400 mg tablets, UDL 


100 count, robot-ready (NDC 51079-0889-19) 


Mylan, UDL, Teva, and Major cannot provide a reason for the shortage. 

Apotex has an import ban on all solid medications including pentoxifylline. 




Choline Magnesium Trisalicylate 



Choline Magnesium Trisalicylate, Caraco 

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



Choline Magnesium Trisalicylate, Marlex 




52

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

manufacturing practice violations. More information is available at 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169093.htm. 

Marlex could not give a reason for their shortage. 




Ipecac Syrup 



Ipecac syrup, 30 mL bottle (NDC 00395-1237-91), Humco- discontinued 

Ipecac syrup, 30 mL bottle (NDC 00574-0012-01), Paddock Laboratories 


Humco discontinued their ipecac syrup in 2010. Paddock has their ipecac syrup on back order 

due to a global raw material shortage. Ipecac syrup is no longer recommended for routine 

management of outpatient ingestions of medications or other chemicals. Guidelines from the 

American Association of Poison Control Centers and the American Academy of Pediatrics do 

not recommend routine stocking of ipecac in households with small children. 

http://www.aapcc.org/archive/FinalizedPMGdlns/Ipecac%20Guideline%20- 

%20final%20for%20JTCT.pdf and the American Academy of Pediatrics 

http://aappolicy.aappublications.org/cgi/content/full/pediatrics;112/5/1182 do not recommend 

routine stocking of ipecac in households with small children. 




Doxazosin 



Doxazosin tablets, Major 

1 mg, 100 count, unit dose (NDC 00904-5522-61) 



Doxazosin tablets, Mylan 

1 mg, 100 count (NDC 00378-4021-01) 

Doxazosin tablets, Teva 

1 mg, 100 count (NDC 00093-8120-01) 

2 mg, 100 count (NDC 00093-8121-01) 


4 mg, 100 count (NDC 00093-8122-01) 

8 mg, 100 count (NDC 00093-8123-01) 

Doxazosin tablets, UDL 




Cardura tablets, Pfizer 

8 mg, 100 count (NDC 00049-2780-66) 


53

Major, Teva, Pfizer, and UDL could not provide a reason for the shortage. 

Apotex has halted manufacturing due to an FDA ban. 




Azithromycin 



Azithromycin suspension, Sandoz 

100 mg/5 mL, 15 mL bottle (NDC 00185-7203-70) 


200 mg/5 mL, 22.5 mL bottle (NDC 00185-7209-69) 


Azithromycin suspension, Pliva (Teva) 

200 mg/5 mL, 22.5 mL bottle (NDC 50111-0767-28) 


Zmax suspension, Pfizer 

2 gram/60 mL adult formulation bottle (NDC 00069-4170-21) - discontinued 

2 gram/60 mL pediatric formulation bottle (NDC 00069-4170-02) - discontinued 


Sandoz states the product has been temporarily unavailable since 2008 due to a management 

decision. 

Teva and Pliva state the shortage is due to supply and demand. 

Pfizer has discontinued their Zmax individual adult and pediatric formulations and replaced these 

with a combined adult and pediatric formulation. 




Chlorpheniramine Maleate Tablets 



Chlorpheniramine maleate, 12 mg extended release tablets, Avanthi 

100 count, NDC number not available, OTC product 

24 count, NDC number not available, OTC product 

Chlor-Trimeton 12 hour, 12 mg extended release tablets, Schering Plough 

10 count (NDC 00085-0009-09), OTC product 

24 count (NDC 00085-0009-03), OTC product 


Chlor-Trimeton is in short supply because Schering Plough is changing manufacturing locations. 

Avanthi received FDA approval to market over-the-counter (OTC) chlorpheniramine maleate in 

May 2009. 

Chlorpheniramine maleate is only available as an OTC product. 




Oxycodone Tablets, Capsules, and Solutions 

54



Immediate Release Tablets 

Oxycodone Immediate-Release Tablets, Actavis 

5 mg, 100 count (NDC 52152-0165-02) - discontinued 

15 mg, unit dose, 100 count (NDC 52152-0214-11) - discontinued 

30 mg, unit dose, 100 count (NDC 52152-0215-11) – discontinued 

Oxycodone Immediate-Release Tablets, Ethex 






30 mg, 100 count (NDC 58177-0446-04) – discontinued 

Oxycodone Immediate-Release Tablets, Mallinckrodt 

5 mg, 100 count (NDC 00406-0552-01) 

5 mg, unit dose, 100 count (NDC 00406-0552-62) 

15 mg, 100 count (NDC 00406-8515-01) 

30 mg, 100 count (NDC 00406-8530-01) 

Immediate Release Capsules 

Oxycodone Immediate-Release Capsules, Ethex 


5 mg, unit dose, 100 count, NDC 58177-0041-11 – discontinued 

OxyIR immediate-release Capsules, Purdue Pharma 


Oxycodone Immediate-Release Capsules, Mallinckrodt 

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

Oxycodone Immediate-Release Capsules, MidLothian Labs 

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

Immediate Release Solution 

Oxycodone Immediate-Release Solution, Glenmark 

20 mg/mL solution, 30 mL (NDC 68462-0347-37) 

Reason for the Shortage: FDA sent warning letters in late-March, 2009 to several suppliers of 

unapproved narcotics. These companies have until May 29, 2009 to stop manufacturing new 

product and distributors have until June 28, 2009 to stop shipping product. The following link 

provides detailed information on the unapproved products: 

http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics. In December, 

2008, KV Pharmaceuticals, which markets prescription medications through Ethex, voluntarily 

suspended shipment of all prescription tablet products 

(http://www.kvpharmaceutical.com/news_center_article.aspx?articleid=276). In early 2009, 

FDA filed an injunction against KV Pharmaceuticals preventing the company from 

55

manufacturing any products until all issues are resolved. Actavis states the shortage was due to 

manufacturing issues. Actavis has discontinued manufacturing their oxycodone 5 mg tablet and 

their 15 mg and 30 mg unit dose product in 100 count packages. Mallinckrodt, Qualitest, and 

Xanodyne are having supply and demand issues. KVK-Tech started releasing new presentations 

in October, 2009. 




Ciprofloxacin Immediate-Release Tablets 



Cipro Tablets, Schering 


500 mg, 100 count (NDC 00085-1754-01) 



750 mg, 100 count, unit dose (NDC 00085-1756-02) - discontinued 

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, Watson (formerly Cobalt) 

250 mg, 100 count (NDC 16252-0514-01) 

500 mg 100 count (NDC 16252-0515-01) 

750 mg 50 count (NDC 16252-0516-05) 

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, Major 



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, Teva 

250 mg, 100 count (NDC 00172-5311-60) 


500 mg, 100 count (NDC 00172-5312-60) 


56

500 mg, 500 count (NDC 00172-5312-70) 

750 mg, 100 count (NDC 00172-5313-60) 


Ciprofloxacin Immediate-Release Tablets, UDL 





Ciprofloxacin Immediate-Release Tablets, Westward 

250 mg, 100 count (NDC 00143-9927-01) 

500 mg, 100 count (NDC 00143-9928-01) 

750 mg, 50 count (NDC 00143-9929-50) 


Apotex has halted manufacturing due to an FDA. 

Ranbaxy has an FDA import ban on several of their products manufactured in India. 

Dr. Reddy’s states their shortage is due to supply and demand issues. 

Major, Marlex, Schering, Teva, UDL, and Westward are unable to provide a reason for their 

shortage. Cobalt was acquired by Watson and Watson will start shipping their products in 

January, 2010. 




Rotigotine Transdermal Systems Patch 



Rotigotine transdermal systems (Neupro), UCB 

2 mg/24 hours, package of 7 (NDC 00091-6486-21) 







UCB is recalling rotigotine transdermal systems due to manufacturing problems and crystal 

formation in the patches. Remaining supplies of rotigotine have been depleted. 




Ganciclovir Capsules 



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. There are no other 

suppliers of ganciclovir tablets. 

57

Article link: 

http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/ 

GettingStarted/CurrentShortages/Bulletin.aspx?id=539 


Cefaclor 



Cefaclor Suspension 125 mg/5 mL, Ranbaxy 

75 mL bottle (NDC 63304-0954-01) 

150 mL bottle (NDC 63304-0954-02) 

Cefaclor Suspension 250 mg/ 5 mL, Ranbaxy 

75 mL bottle (NDC 63304-0956-01) 

150 mL bottle (NDC 63304-0956-02) 

Cefaclor Suspension 375 mg/ 5 mL, Ranbaxy 

50 mL bottle (NDC 63304-0957-03) 

100 mL bottle (NDC 63304-0957-04) 


Cefaclor suspension is one of 30 generic products from Ranbaxy that has an FDA import ban. 

There are no other manufacturers of cefaclor suspension. 




Thyroid Tablets 



Products in Short Supply 

Thyroid (desiccated) 120 mg tablets, 1000s (NDC 00904-0762-80), Major - discontinued 

Thyroid (desiccated) 120 mg tablets, 100s, 00904-0762-60, Major - discontinued 

Thyroid (desiccated) 30 mg tablets, 100s (NDC 00904-7865-60), Major- discontinued 






Armour Thyroid 15 mg tablets, 100s (NDC 00456-0457-01), Forest 


Armour Thyroid 30 mg tablets, unit dose, 100s (NDC 00456-0458-01), Forest 











58



Nature-Throid NT-1/4 16.25 mg (1/4 grain) tablets, 100s (NDC 64727-3298-01), RLC 

Nature-Throid NT-1/2 32.4 mg (1/2 grain) tablets, 100s (NDC 64727-3299-01), RLC 

Nature-Throid NT-2 129.6 mg (2 grain) tablets, 100s (NDC 64727-3308-01), RLC 

Nature-Throid NT-3 194.4 mg (3 grain) tablets, 100s (NDC 64727-3312-01), RLC 

Westhroid 32.5 mg (1/2 grain) tablets, 100s (NDC 64727-7070-01), RLC 

Westhroid 32.5 mg (1/2 grain) tablets, 1000s (NDC 64727-7070-02), RLC 

Westhroid 65 mg (1 grain) tablets, 100s (NDC 64727-7073-01), RLC 




Discontinued Products 

Thyroid (desiccated) capsules (Bio-Tech Pharm) - discontinued 

Thyroid (desiccated) tablets (Qualitest) - discontinued 

Thyroid (desiccated) tablets (Time-Cap) – discontinued 

Thyroid (desiccated) tablets (Major) - discontinued 

Reason for the Shortage: Several thyroid (desiccated) products have been discontinued. The 

manufacturers would not provide a reason for the discontinuations; however these products are 

not FDA-approved. Forest states that the shortage of Armour Thyroid is due to a shortage of raw 

material. RLC states the shortage is because of high demand for the product. Major has 

discontinued their thyroid (desiccated) products. 




Sotalol 



Sotalol Hydrochloride 

Sotalol hydrochloride, Apotex 

80 mg, package of 100 (NDC 60505-0080-00) 




Sotalol hydrochloride, Global Pharmaceuticals 

80 mg, package of 100 (NDC 00115-2711-01) — discontinued 



Sotalol hydrochloride, Sorine, Upsher-Smith 





59

Sotalol hydrochloride, Par 






Sotalol Hydrochloride AF 

Sotalol hydrochloride AF, Amneal 


Sotalol hydrochloride AF, Apotex 





Apotex has an import ban on all of their solid presentations including sotalol tablets. 

Global Pharmaceuticals, Upsher-Smith, and Par have discontinued their products. 




Senna Tablets 

February 1, 2010 


Senna Tablets 

Sennakotxtra, 17.2 mg tablets, Purdue Products 

Package of 36 (NDC 67618-0315-36) 

Senna Plus Docusate Sodium Tablets 

1000 count bottles (NDC 67618-0310-13)- discontinued 


Purdue reports a delay in packaging for some of their products. 

Several manufacturers of Senna and Senna-S voluntarily recalled specific lot numbers of their 

products due to undeclared lactose and tartaric acid content. Companies who initiated the recall 

included Purdue Products, Teva, Watson, Concord, and Major. 

Ranbaxy and Amneal Pharmaceuticals discontinued their senna products. 

Senna products are available over-the-counter and are not prescription products. 




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) 

60

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. 




Hexachlorophene 

Febuary 1, 2010 


Phisohex 3% Detergent Cleanser, Sanofi 

150 mL bottle, package of 1 (NDC 00024-1535-02) 






Sanofi cannot provide a reason for the shortage. 




Oseltamivir Phosphate 



Tamiflu capsules and 12 mg/mL oral suspension, Roche 

12 mg/mL suspension, 25 mL (NDC 00004-0810-95) 

Tamiflu capsules, Roche 

30 mg capsules (NDC 00004-0802-85) 




Roche has Tamiflu suspension on shortage due to increased demand for the product. 




Acetaminophen 



Feverall 80 mg suppository, Actavis 

Package of 6 (NDC 00472-1200-06) 

Package of 50 (NDC 00472-1200-50) 


Actavis is the only manufacturer of acetaminophen 80 mg suppositories. The suppositories are 

temporarily unavailable due to production issues. 

Acetaminophen 120 mg suppositories are available from multiple manufacturers 

61




Erythromycin Ophthalmic Ointment 



Erythromycin Ophthalmic Ointment, 5 mg/gram 

3.5 gram tube (NDC 48102-0008-35), Fera 


3.5 gram tube (NDC 17478-0070-35), Akorn – discontinued 


1 gram tube, package of 50 (NDC 00168-0070-11), Fougera - discontinued 

3.5 gram tube, package of 1 (NDC 00168-0070-38), Fougera – discontinued 

3.5 gram tube, package of 24 (NDC 00168-0070-39), Fougera - discontinued 


3.5 gram tube, package of 1 (NDC 00223-4288-03), Consolidated Midland - discontinued 


1 gram tube, package of 50 (NDC 24208-0910-19), Bausch and Lomb 

3.5 gram tube, package of 1 (NDC 24208-0910-55), Bausch and Lomb 


3.5 gram tube, package of 1 (NDC 51394-0479-35), Wilson - discontinued 


3.5 gram tube, package of 1 (NDC 54799-0540-35), Ocusoft 


Akorn Consolidated Midland has discontinued their products. 

Fougera has sold erythromycin ophthalmic ointment, along with six other ophthalmic ointments, 

to Fera Pharmaceuticals. It is estimated that erythromycin ophthalmic ointment will be available 

in 2010. 

Bausch and Lomb and Ocusoft have product on shortage due to increased demand for the 

product. 

Wilson has discontinued their erythromycin ophthalmic ointment. The company could not 

provide a reason for this discontinuation. 




62

February 2010 Drug Information Update - Pharmacy Benefits ...

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