Drug 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,
D-0579-2023
Product summary
- Event
- Event 92292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,380
- Official record key
drug-enforcement:D-0579-2023
Official wording
Reason: Subpotent: Low anti-factor IIa Potency.
Code information: Lot Number: J1P154N, Exp: 31 May, 2023,
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent