FDA: Coumadin Lot Recalled as a Precaution



The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

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