Drug product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
D-0593-2023
Product summary
- Event
- Event 92341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,229,090 vials
- Official record key
drug-enforcement:D-0593-2023
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