FDA Recall Ampicillin And Sulbactam
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Ampicillin And Sulbactam with NDC 71288-006 was initiated on 05-15-2023 as a Class II recall due to lack of assurance of sterility The latest recall number for this product is D-0593-2023 and the recall is currently terminated as of 04-05-2024 .
Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
---|---|---|---|---|---|---|
D-0593-2023 | 05-15-2023 | 05-24-2023 | Class II | 1,229,090 vials | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30 | Terminated |
D-0592-2023 | 05-15-2023 | 05-24-2023 | Class II | 236,610 vials | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.