Drug product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
D-0592-2023
Product summary
- Event
- Event 92341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 236,610 vials
- Official record key
drug-enforcement:D-0592-2023
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