May 03, 2011
RECALL: Coumadin 5mg Tablets Recalled Due to Higher than Expected PotencyBristol-Myers Squibb has initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) 5mg tablets because they may contain tablets higher in potency than expected. Testing of a returned bottle from Lot # 9H49374A found a single tablet to be higher in potency than the labeled 5mg dosage strength.
Patients who are in possession of Coumadin 5mg 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, consult their physician for appropriate medical advice.
Coumadin is indicated for the treatment of thromboembolic disorders; thromboembolic complications from atrial fibrillation, cardiac valve replacement; and for the reduction of risk of death, recurrent myocardial infarction (MI), and thromboembolic events post-MI. An increase in the active ingredient may increase the risk of bleeding.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm253615.htm.