Audience: hematologists, cardiologists, risk managers
July 12, 2010 — Bristol-Myers Squibb announced the recall of certain lots of Coumadin 1 mg physician sample blister packs. It has been determined that some tablets may not meet the specification for isopropanol. Isopropanol is used to maintain Coumadin in the crystalline state, and could affect the therapeutic levels of Coumadin. A decrease in the active ingredient may increase the risk of clots, which could lead to a heart attack or stroke. If there is too much active ingredient, there is an increased risk of bleeding.
The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiration dates between June 2011 and November 2012.
The recall only involves Coumadin 1 mg tablet blister packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
July 12, 2010 — Press release
