One Lot of Coumadin Recalled Over Potency Fears
Coumadin -- also known as warfarin sodium -- is prescribed to treat and prevent blood clots, and to lower the risk of heart attacks and strokes. However, too much of the active ingredient in the medication means there would be an increased risk of bleeding, the FDA said.
Consumers should talk to their doctors immediately if they experience any problems, including pain, swelling, headache and dizziness, unusual bruising, nosebleeds and bleeding from cuts that take a long time to stop.Included in the recall is one lot of 1,000-count bottles of Coumadin Crystalline 5 mg tablets, lot number 9H49374A, with an expiration date of September 30, 2012. The bottles were distributed to pharmacies for further dispensing to consumers.
Bristol-Myers Squibb said the recall is precautionary and is based on the company's testing of tablets from a returned bottle. The tests showed a single table was higher in potency than expected.
Consumers should continue taking the medicine but should contact their pharmacist to see if they have tablets from the recalled lot. If so, they should contact their doctors immediately.
For further information, consumers can call Bristol-Myers Squib at (866) 918-8739.
In February, Upsher-Smith Laboratories recalled a single lot of its Jantoven Warfarin Sodium USP 3 mg tablets because a bottle contained higher-strength (10 mg) tablets.