Recalls / Class II
Class IID-0916-2023
Product
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
- 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#: 0061858305, 0061858306 Exp 3/31/2025
Why it was recalled
Lack of assurance of sterility: bags have the potential to leak.
Recalling firm
- Firm
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1845 Mason Ave, N/A, Daytona Beach, Florida 32117-5102
Distribution
- Quantity
- 79,880 bags
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-07-05
- FDA classified
- 2023-07-13
- Posted by FDA
- 2023-07-19
- Terminated
- 2024-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0916-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.