June 20, 2019
Subpotency concerns have prompted B. Braun Medical Inc. to recall 40,176 bags of heparin sodium in dextrose (NDC 0264-9587-20), according to the June 19, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects heparin sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% dextrose injection, 250-mL EXCEL container bags, from lot J7B259 (Exp. 8/31/19). The affected product was distributed throughout the United States.
B. Braun Medical Inc. voluntarily initiated the recall June 13, 2019. The same day, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Heparin injection is a prescription anticoagulant used to prevent and treat blood clots caused by medical conditions or procedures, including surgery.