Coumadin Recalled Over Potency Issue

Bristol-Myers Squibb just initiated a recall of one lot of 1,000-count bottles of <"">Coumadin® (warfarin sodium) Crystalline 5 mg tablets, the U.S. Food and Drug Administration (FDA) just announced.

Bottles of 1,000 tablets were distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the United States is 9H49374A with an expiry date of September 30, 2012.

The Coumadin recall was implemented based on the company’s testing of tablets from a returned bottle in which a single tablet was found to be higher in potency than expected.

Coumadin is prescribed to treat or prevent blood clots. A decrease of the active ingredient may increase the risk of clots, which could, in turn, lead to heart attack or stroke. If too much active ingredient is present, there is an increased risk of bleeding.

Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to determine if they are in possession of tablets originating from the affected lot. If so, patients should consult their physicians for appropriate medical advice, said the FDA.

Bristol-Myers Squibb notified the FDA and said it will issue recall communications to all physicians and other customers involved.

Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787; or on the MedWatch website at Stericycle, Inc.
can be reached at 1.866.918.8739 for patient and physician information.

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