Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

FDA recall notice · announced May 24, 2023 · B. Braun Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

Reason for recall

Subpotent: Low anti-factor IIa Potency.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot Number: J1P154N, Exp: 31 May, 2023,
Quantity: 1,380
Status: Terminated
Products in this recall event:
- Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20, (D-0579-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.