Coumadin Recall - 1 mg Tablet Blister Packs

The National Blood Clot Alliance wants to alert patients and healthcare providers to this important FDA MedWatch recall. Please distribute to appropriate patients, healthcare providers, or healthcare organizations. "Being certain that you are taking the correct dose or amount of Coumadin is key to successful therapy. If there has been a manufacturing error in the content of the 1 mg tablets (identified below), then it is essential to discard and replace them" says Jack Ansell, MD, Chairman of the Medical & Scientific Advisory Board of the National Blood Clot Alliance.

Please distribute this information to all individuals and organizations who may benefit from the distribution of this information.

Coumadin 1 mg Tablet Blister Packs: Recall
AUDIENCE: Hematology, Cardiology, Risk Manager

ISSUE: Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding.

The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.

BACKGROUND: The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.

RECOMMENDATION: See the company Press Release for additional contact information. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms <http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm> " page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218955.htm

Please distribute this information to all individuals and organizations who may benefit from the distribution of this information.

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