Warfarin 5 mg tablets - Voluntary Recall of a Single Lot of Coumadin 5 mg Tablets
May 5, 2011
Bristol-Myers Squibb is recalling one lot of warfarin sodium (Coumadin®) 5 mg tablets. The recalled tablets were distributed in 1000-count bottles with the lot number 9H49374A (expiration date 9/30/2012). The company found that one tablet in a returned bottle from lot 9H49374A had higher-than-expected potency. Other lot numbers of Coumadin are not affected by this recall.
Warfarin dosing is carefully individualized. Inadvertent increased potency may increase the risk of bleeding, whereas decreased potency may increase the risk of clots.
Patients taking Coumadin 5 mg tablets should continue to take their medication as prescribed, but should check with their dispensing pharmacy to find out if their tablets came from the affected lot. Patients with product from the recalled lot are instructed to notify their physicians for medical advice. Patients and healthcare providers may contact Stericycle, Inc. by phone at 866-918-8739 for more information on this recall.
Additional information is available at the following links:
- MedWatch alert:
- Press release:
May 5, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.