Visible particulate matter found in small number of unreleased samples
Bristol-Myers Squibb is voluntarily recalling six lots of blood clot treatment Coumadin for Injection, 5mg single-use vials in the US. The recall is a precautionary measure after the company found visible particulate matter in a small number of unreleased samples.
The company says 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 embolisation.
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. This recall will have no impact on the oral formulation, Coumadin tablets.
This recall is being conducted with the knowledge of the US Food and Drug Administration.