Drug product
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
D-0431-2024
Product summary
- Event
- Event 94272
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,800 bags
- Official record key
drug-enforcement:D-0431-2024
Official wording
Reason: Lack of assurance of sterility: bags have the potential to leak..
Code information: Lot #: J3N023, Exp: 31 March 2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility