Recalls / Class II
Class IID-0579-2023
Product
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, 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 Number: J1P154N, Exp: 31 May, 2023,
Why it was recalled
Subpotent: Low anti-factor IIa Potency.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 Mcgaw Ave, N/A, Irvine, California 92614-5841
Distribution
- Quantity
- 1,380
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-05-09
- FDA classified
- 2023-05-16
- Posted by FDA
- 2023-05-24
- Terminated
- 2024-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0579-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.