Drug 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.
D-0491-2025
Product summary
- Event
- Event 97059
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 187,656 containers
- Official record key
drug-enforcement:D-0491-2025
Official wording
Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Code information: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility