Drug product
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
D-0916-2023
Product summary
- Event
- Event 92640
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79,880 bags
- Official record key
drug-enforcement:D-0916-2023
Official wording
Reason: Lack of assurance of sterility: bags have the potential to leak.
Code information: Lot#: 0061858305, 0061858306 Exp 3/31/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility