D-1343-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- June 13, 2019
- Termination Date
- July 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,176 bags
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: J7B259, Exp 31 Aug 2019