Bristol-Myers Squibb Company has announced a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the United States. The company reports that the recall is a precautionary measure based on the company's investigation of visible particulate matter found in a small number of unreleased samples.
Bristol-Myers Squibb reports in a statement that it 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, the company reports. 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 is a prescription medicine used to treat blood clots and to lower the chance of blood clots forming in the body. The drug is typically administered in a hospital setting by health care professionals to patients not able to receive the oral formulation.
Coumadin for Injection 5 mg single-use vials is packaged in cartons of six vials. The affected product includes the six lots distributed to hospitals and pharmacies from November 2011 through January 2014.
The recall is being conducted with the knowledge of the US FDA.