Safety Alerts & Recalls

What does this mean?

Bristol-Myers Squibb is conducting this recall with the knowledge of the FDA. At this time, there have been no reports of adverse events related to the recalled tables and the company believes that these recalled Coumadin 1 mg tablets do not pose a significant health risk to patients. That said, it is very important to keep your blood clotting time at the target level to prevent future clots and avoid side effects of bleeding. If your doctor or other healthcare provider has provided you with samples of Coumadin 1 mg, you should check to see if they are labeled with any of the recalled lot numbers: 9A48931A, 9A48931B, 9A48931C, 8F34006B, 8k44272A, 8K46168A, 9F44437A, or 9K58012B. If you have any of these recalled tablets, it is best to avoid using them. If these are the only tablets you have, please continue taking your Coumadin and follow up with your doctor or pharmacist to get a new supply.

If you have been taking these recalled tablets, you should follow up with the doctor or healthcare professional who is managing your Coumadin treatment and discuss any concerns you have. Your doctor or healthcare professional may want to measure your blood clotting time to make sure you are not at risk for problems from these recalled tablets.

Bristol-Myers Recalls Coumadin Blister Pack Samples

Bristol-Myers Squibb has voluntarily recalled a number of blister packs of Coumadin 1 mg tablets. The recalled tablets were distributed as blister pack samples intended for doctors to give to their patients. These blister packs of Coumadin 1 mg tablets are being recalled because of the possibility that some of the tablets may not contain the correct amount of isopropanol, an additive required to maintain the active ingredient in a crystalline state. Use of tablets with low isopropanol could lead to patient-to-patient variation in absorption by the body and possibly cause trouble controlling blood clotting time (also called prothrombin time or International Normalized Ratio [INR]).

The recalled lots include physician samples labeled 9A48931A, 9A48931B, and 9A48931C, and hospital unit dose (HUD) blister packs 8F34006B, 8k44272A, 8K46168A, 9F44437A, and 9K58012B.

Coumadin is often prescribed to patients with a history of irregular heartbeat, prosthetic heart valve, or clot in the lower leg. The medication helps to thin the blood and decrease the risk of blood clots in the veins, lungs, or brain. Coumadin contains the active ingredient warfarin.

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Source: Manufacturer
Publication Date: 2010-07-06
Last Updated: 2010-07-14

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