Physician Sample Packs of Coumadin Recalled

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-Myers Squibb has initiated a voluntary recall of 3 lots of physician sample blister packs and 5 lots of hospital unit dose (HUD) blister packs of Coumadin 1 milligram tablets. The recall is a precautionary measure based upon the company’s determination that some of the ingredients may not meet specification for isopropanol, a compound that helps maintain the drug’s active ingredient in a crystalline state.

To date, Bristol-Myers Squibb has not received any reports of adverse effects related to this issue.

Coumadin is prescribed to treat or prevent blood clots. Physicians monitor blood levels closely during treatment to ensure adequate anticoagulation. A decrease in the active ingredient may increase the risk of clots which could lead to heart attack or stroke. An increase in the active ingredient can cause bleeding.

The following lot numbers are included in the recall:

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• 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

The recall only involves the above products distributed in the US and does not involve Coumadin 1 milligram tablets supplied in bottles. The recall does not involve other strengths or dosages of the medication.

Physicians with tablets from these lots are instructed to return them to BMS' designated recall vendor, Stericycle. BMS sales representatives are not permitted to handle drug samples once they have been given to physicians. Stericycle may be contacted at 877-546-0128. General inquiries about the recall can be directed to Bristol-Myers Squibb Customer Relations at 1-800-332-2056.

Patients who may have product from the recalled lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted. Any adverse effects should be reported to the FDA MedWatch Program:

• Fax: 1-800-FDA-0178
• Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Website: www.fda.gov/medwatch

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