Recalls / Class II
Class IID-0655-2022
Product
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
- 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 #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023
Why it was recalled
Lack of sterility assurance: leaking bags
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Other
- Type
- Voluntary: Firm initiated
- Address
- 901 Marcon Blvd, N/A, Allentown, Pennsylvania 18109-9512
Distribution
- Quantity
- 33,742 bags
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-02-25
- FDA classified
- 2022-03-17
- Posted by FDA
- 2022-03-23
- Terminated
- 2023-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0655-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.