Bristol-Myers Squibb Company has issued a voluntary recall in the U.S. of six lots of Coumadin (warfarin sodium) for Injection, 5 mg single-use vials. The recall comes after visible particle matter was found in a small number of unreleased samples of the drug. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur. To date, no product complaints or adverse events have been reported to Bristol-Myers Squibb related to this issue.
Coumadin for Injection was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not affected by this recall.
The affected Coumadin for Injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229, 201230.
Bristol-Myers Squibb recommends that anyone in possession of Coumadin for Injection from the affected lots stop use and distribution of the drug and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 10855-5784 to arrange for return of remaining stock. Bristol-Myers Squibb has issued recall communications to health care professionals and other customers involved and is arranging for return of all recalled products
The Food and Drug Administration (FDA) encourages health care professionals and patients 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: