Recalls / Class II
Class IID-0491-2025
Product
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0264-7800, 0264-7802
- FDA application
- NDA019635
- Affected lot / code info
- Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Why it was recalled
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Recalling firm
- Firm
- B BRAUN MEDICAL INC
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 861 Marcon Blvd, Allentown, Pennsylvania 18109-9577
Distribution
- Quantity
- 187,656 containers
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-06-16
- FDA classified
- 2025-06-24
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0491-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.