Drug product
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
D-0655-2022
Product summary
- Event
- Event 89665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,742 bags
- Official record key
drug-enforcement:D-0655-2022
Official wording
Reason: Lack of sterility assurance: leaking bags
Code information: Lot #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of sterility