Bristol-Myers Squibb announced a voluntary recall of several lots of Coumadin (warfarin sodium) 1mg tablet blister packs. This recall is being conducted because some of the tablets, over time, may not meet the specification for isopropanol, which is used to maintain warfarin in the crystalline state, and could affect the therapeutic levels of the drug. Patients in possession of the recalled lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.
The following lots are being recalled:
- Physician Sample Blister Packs: Lot # 9A48931A, 9A48931B, 9A48931C, expiration January 2012
- Hospital Unit Dose Blister Packs: Lot # 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012
Coumadin is indicated for the management of thromboembolic disorders; thromboembolic complications from atrial fibrillation, cardiac valve replacement; and to reduce risk of death, recurrent MIs, and thromboembolic events post-MI.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218955.htm.