Recalls / Class II
Class IID-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.
- Brand name
- Heparin Sodium In Dextrose
- Generic name
- Heparin Sodium And Dextrose
- Active ingredients
- Dextrose Monohydrate, Heparin Sodium
- Route
- Intravenous
- NDCs
- 0264-9567, 0264-9577, 0264-9587
- FDA application
- NDA019952
- Affected lot / code info
- Lot #: J7B259, Exp 31 Aug 2019
Why it was recalled
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.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2525 Mcgaw Ave, N/A, Irvine, California 92614-5841
Distribution
- Quantity
- 40,176 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-06-13
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2022-07-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1343-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.