Bristol-Myers Squibb is voluntarily recalling six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. This 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. Bristol-Myers Squibb 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 is a prescription medicine used to treat blood clots and to lower the chance of blood clots forming in the body. Coumadin for Injection 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 Coumadin for Injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014:
Lot Number Description NDC Expiration
201125 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sep-2014
201126 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Nov-2014
201127 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Dec-2014
201228 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Jun-2015
201229 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Jul-2015
201230 COUMADIN LINJ 5MG (6VL) US 0590-0324-35 Sep-2015
Bristol-Myers Squibb has issued recall communications to health care professionals and other customers involved and is arranging for return of all recalled products.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Release Date: June 30, 2014