Drug recall D-1343-2019
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.
Reason for recall
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.
Lots and codes
Lot #: J7B259, Exp 31 Aug 2019
Recall details
- Recalling firm
- B. Braun Medical Inc, Irvine, CA
- Quantity
- 40,176 bags
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 13, 2019
- Terminated
- July 15, 2022
Related products
- Heparin Sodium in Dextrose – drug information
- NDC 0264-9587 Heparin Sodium in Dextrose · Heparin Sodium 10000 [USP'U]/100mL; Dextrose Monohydrate 5… · B. Braun Medical Inc.
- NDC 0264-9577 Heparin Sodium in Dextrose · Heparin Sodium 5000 [USP'U]/100mL; Dextrose Monohydrate 5… · B. Braun Medical Inc.
- NDC 0264-9567 Heparin Sodium in Dextrose · Heparin Sodium 4000 [USP'U]/100mL; Dextrose Monohydrate 5… · B. Braun Medical Inc.