If you take the blood-thinning medication coumadin, your medication may have been recalled.
The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths or dosage forms of the product.
The following lot numbers are included in this recall:
- Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012;
- HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
If you think you may have a product from the recalled lots, contact your physician immediately. Do not stop taking the medication without talking to your doctor–you need to ensure that your anticoagulation therapy is not interrupted.
The manufacturer of the drug, Bristol-Myers Squibb, determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots, which could lead to heart attack or stroke… and if there is too much active ingredient, there is an increased risk of bleeding.
For more information, see the company press release: Coumadin Recall.
Also, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
If you are concerned that you may have been injured by this or any other medication and want to explore your legal options, feel free to contact the HensonFuerst drug injury team at 1800-4LAW-MED, or see our website for more information (www.hensonfuerst.com).