Recalls / Class II
Class IID-0076-2023
Product
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0264-5802, 0264-5804
- FDA application
- NDA019635
- Affected lot / code info
- Lot: 0061832446 Exp. 31 Oct 2024
Why it was recalled
Lack of sterility assurance: Bags have the potential to leak.
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 901 Marcon Blvd, N/A, Allentown, Pennsylvania 18109-9512
Distribution
- Quantity
- 756 bags
- Distribution pattern
- FL, NJ, PA
Timeline
- Recall initiated
- 2022-11-25
- FDA classified
- 2022-12-05
- Posted by FDA
- 2022-12-14
- Terminated
- 2024-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0076-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.