Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets
Bristol-Myers Squibb has initiated a recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities.
The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.
Coumadin is prescribed to treat or prevent blood clots. If there is too much active ingredient, 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 see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.
Health care professionals and customers may contact Stericycle, Inc at 1-866-918-8739 for assistance if they have further questions about the recall.
medwatchAny adverse events that may be related to the use of the affected products should be reported to the FDA’s MedWatch Adverse Event Reporting program. The report may be made by phone at 1-800-FDA-1088, online at www.fda.gov/MedWatch/report.htm, or by returning the postage paid FDA form 3500. The form may be downloaded from www.fda.gov/MedWatch/getforms.htm and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to 1-800-FDA- 0178