Drug product
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
D-0583-2023
Product summary
- Event
- Event 92341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,160 vials
- Official record key
drug-enforcement:D-0583-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility