Bristol-Myers Squibb announced a voluntary recall of 6 lots of Coumadin (warfarin sodium), for Injection, 5mg single-use vials, in the U.S. This recall is a precautionary act following the company’s investigation of visible particulate matter found in a small unreleased batch of Coumadin for Injection.
If metallic and non-metallic cellulose material is injected, serious and potentially fatal reactions can occur such as embolization. Also, allergic reactions to the foreign particulate may occur. The affected products contain Lot# 201125 (Exp. 9/2014), 201126 (Exp. 11/2014), 201127 (Exp. 12/2014), 201228 (Exp. 6/2015), 201229 (Exp. 7/2015), and 201230 (Exp. 9/2015). The 5mg single-use vials are packaged in 6-count cartons and were distributed from November 2011–January 2014. This recall only affects the injection formulation, which was discontinued in early April 2014; the tablets are not affected.
Bristol-Myers Squibb has issued communications to healthcare professionals and other customers involved. Anyone that has the affected Coumadin for Injection should discontinue use and arrange for return of remaining stock.
Coumadin is an anticoagulant indicated to treat venous thrombosis, pulmonary embolism, thromboembolic complications from atrial fibrillation and/or cardiac valve replacement, and to reduce risk of death, recurrent MIs, and thromboembolic events (eg, stroke, systemic embolization) post-MI.
For more information call (855) 838-5784 or visit FDA.gov.