Recalls / Class III
Class IIID-1083-2023
Product
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, 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 #: 0061852531, Exp 2/28/2025
Why it was recalled
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
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
- 43,812 bags
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2023-08-02
- FDA classified
- 2023-08-08
- Posted by FDA
- 2023-08-16
- Terminated
- 2025-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1083-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.