Drug product
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
D-1343-2019
Product summary
- Event
- Event 83089
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,176 bags
- Official record key
drug-enforcement:D-1343-2019
Official wording
Reason: Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
Code information: Lot #: J7B259, Exp 31 Aug 2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent