Drug product
Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
D-0591-2023
Product summary
- Event
- Event 92341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 419,680 vials
- Official record key
drug-enforcement:D-0591-2023
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