IGMPI India

Bristol-Myers Squibb, a global biopharmaceutical company has issued a voluntary recall of six lots of COUMADIN® (warfarin sodium) for injection, 5 mg single-use vials in the U.S. The recall is a precautionary measure based on the company’s investigation after visible particulate matter was found in a small number of unreleased samples. According to the company no product complaints or adverse events related to the drug have been reported so far.

The six lots recalled are 00201125, 00201126, 00201127, 00201128, 00201129 and 00201130 which were distributed between November 2011 and January 2014. Coumadin is an anticoagulant used to treat venous thrombosis, pulmonary embolism, thromboembolic complications from atrial fibrillation and/or cardiac valve replacement, and to reduce risk of death, recurrent MIs, and thromboembolic events post-MI. Coumadin injection was discontinued in early April 2014. The oral formulation, Coumadin tablets, ishowever not affected by this recall.Coumadin for injection was intended for patients not able to receive the oral medication. The injectable version of Coumadin is a freeze-dried form of the traditional warfarin tablet which is delivered intravenously after it is reconstituted with water.

If metallic and non-metallic cellulose material is injected, it can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign particulate may also occur. Further, the product's labeling also advises patients to visually inspect the vial for particulate matter and discoloration prior to administration. Bristol-Myers Squibb however felt the need to initiate this recall.