Recalls / Class II
Class IID-0434-2023
Product
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. 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 J2C017; Expiration: 9/30/2023.
Why it was recalled
Subpotent Drug: low Anti-Factor IIa potency.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Address
- 2525 Mcgaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 30672
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-01
- FDA classified
- 2023-03-06
- Posted by FDA
- 2023-03-15
- Terminated
- 2024-03-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0434-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.