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FDA issues safety alert on injectable warfarin recall

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The FDA recently announced that Bristol-Myers Squibb has voluntarily recalled six lots of 5 mg single-use vials of warfarin for injection, due to the presence of particulate matter.

However, the FDA reported the issue does not affect the more prevalent oral formulation of warfarin.

According to a Bristol-Myers Squibb press release, the safety risk to patients is low, and is further mitigated by warfarin (Coumadin) prescribing information advising that intravenous drug products be inspected visually prior to administration.

Injected particulate metallic and non-metallic cellulose material have been noted to 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.

Discontinued in early April 2014, the affected warfarin for injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229 and 201230.