BMS Issues Voluntary Recall Of 6 Lots Of Coumadin

Bristol-Myers Squibb said that is voluntarily recalling six lots of Coumadin 5 mg single use vials for injection in the U.S. due to suspected particulate matter.

The company issued the recall as a precautionary measure following an investigation that turned up visible particulate matter in a few, unreleased units of Coumadin for injection samples. Though BMS said it believes the safety risk to patients is low, it cautioned that injected particulate material can lead to serious and potentially deadly adverse reactions such as embolization. The company also warned against potential allergic reactions to foreign material.

Coumadin for injection is a prescription drug indicated for the treatment and prevention of blood clots. The affected lots, containing 5 mg single use vials packaged in cartons of six vials, includes the following batches: 00201125, 00201126, 00201127, 00201128, 00201129, and 00201130. The lots were distributed to hospitals and pharmacies from November 2011 through January 2014. Production of Coumadin for injection was discontinued in early April this year.

The company is arranging for the return of all recalled products from healthcare professionals and other customers. No product complaints or adverse events have been reported to date to the company regarding Coumadin for injection.

BMS said the recall is being undertaken with the knowledge of the U.S. Food and Drug Administration (FDA), to which customers can report adverse reactions or quality problem experiences with the affected product.