News Flash

Coumadin 1 mg Tablet Blister Packs Recalled

July 14, 2010

The FDA and Bristol-Myers Squib have issued a voluntary recall of Coumadin 1 mg tablet blister packs due to the possible changing effectiveness of the drug over time.

  • A decrease in effectiveness of Coumadin may lead to an increased risk of blood clots, causing a possible heart attack or stroke
  • An increase in effectiveness of Coumadin may increase the risk for bleeding

The following lots numbers have been recalled:

Physician Sample Blister Packs:

  • Lot # 9A48931A
  • Lot # 9A48931B
  • Lot # 9A48931C
  • Only packs with above lot number and an expiration date of January 2012

HUD Blister Pack:

  • Lot # 8F34006B
  • Lot # 8K44272A
  • Lot # 8K46168A
  • Lot # 9F44437A
  • Lot # 9K58012B
  • Only packs with above lot number and expiration dates between June 2011 and November 2012

Patients who use this product should contact their physicians to ensure their anticoagulation therapy is not interrupted and to report any adverse or unusual side effects associated with taking this medication.

For more information, please read the complete MedWatch 2010 Safety Summary.