BMS Voluntarily Recalls Six Lots of Coumadin for InjectionBy
Bristol-Myers Squibb Company (BMS) is voluntarily recalling six lots of Coumadin (warfarin sodium) for Injection, 5-mg single-use vials, in the US. The recall is a precautionary measure based on the company's investigation of visible particulate matter found in a small number of Coumadin for Injection unreleased samples. BMS believes the safety risk to patients is low and is further mitigated by the product's prescribing information advising that intravenous drug products be inspected visually prior to administration.
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, there have been no product complaints or adverse events 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 impacted by this recall.
Coumadin for Injection, 5-mg single-use vials, is packaged in cartons of six vials. The affected six lots were distributed to hospitals and pharmacies from November 2011 through January 2014.
Source: Bristol-Myers Squibb