After Bristol Myers-Squibb determined that the effectiveness of their Coumadin, also called warfarin, a common blood thinner, may change over time due to the ingredient, isopropanol, not meeting quality specifications, the FDA announced the Recall on Monday, July 12th.
Isopropanol is used to keep the Coumadin's active ingredient in a crystalline state, the changing levels of isopropanol could increase or decrease the amount of the active ingredient in the tablets. In some cases, the dose may be too high, which can increase your risk of bleeding. For others, the dose could be too low, increasing your risk of blood clots, heart attack and stroke.
Coumadin 1 mg tablets, physician sample blister packs:
Lot numbers: 9A48931A, 9A48931B and 9A48931C
Expiration Date: January 2012
Coumadin 1 mg tablets, hospital unit dose blister packs:
Lot numbers: 8F34006B, 8K44272A, 8K46168A, 9F44437A, and 9K58012B
Expiration Date: June 2011 - Nov. 2012
Any adverse reactions should be reported to the FDA's MedWatch adverse events reporting program at www.fda.gov/medwatch .