Drug product
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
D-0076-2023
Product summary
- Event
- Event 91194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 756 bags
- Official record key
drug-enforcement:D-0076-2023
Official wording
Reason: Lack of sterility assurance: Bags have the potential to leak.
Code information: Lot: 0061832446 Exp. 31 Oct 2024
Distribution pattern: FL, NJ, PA
Derived failure modes
-
Sterility assurance
Lack of sterility