Injectable Coumadin Recalled Due to Particulates; Possible Patient Injury

Bristol-Myers Squibb Company recalled six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. This recall is based on the company's investigation of visible particulate matter found in a small number of Coumadin for Injection unreleased samples.


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.


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, are packaged in cartons of six vials. The affected Coumadin for Injection includes six lots distributed to hospitals and pharmacies from November 2011 through January 2014. The lot numbers are 201125 through 201127 and 201228 through 201230. Coumadin for Injection was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not impacted by this recall.


See the FDA Recall


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication