Bristol-Myers Squibb Company Initiates a Nationwide Voluntary Recall of Coumadin
Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and 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.
Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and 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, MD 20852-9787, or on the MedWatch website at www.fda.gov1.
Health care professionals and customers may call the following for assistance if they have further questions about the recall:
For information related to this recall: Stericycle, Inc. 1-866-918-8739