Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
FDA recall notice · announced March 15, 2023 · B. Braun Medical
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
Reason for recall
Subpotent Drug: low Anti-Factor IIa potency.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot J2C017; Expiration: 9/30/2023.
Quantity: 30672
Status: Terminated
Products in this recall event:
- Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20. (D-0434-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.