Drug 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.
D-0434-2023
Product summary
- Event
- Event 91769
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30672
- Official record key
drug-enforcement:D-0434-2023
Official wording
Reason: Subpotent Drug: low Anti-Factor IIa potency.
Code information: Lot J2C017; Expiration: 9/30/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent