Class II
Terminated
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.
This recall has been terminated (originally issued June 19, 2019).
- Company
- B. Braun Medical Inc
- Recall Initiated
- June 13, 2019
- Posted
- June 19, 2019
- Recall Number
- D-1343-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 40,176 bags
- Firm Location
- Irvine, CA, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA
Lot / Code Info
Lot #: J7B259, Exp 31 Aug 2019
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