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-0593-202305-15-202305-24-2023Class II1,229,090 vialsAmpicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30Terminated
D-0592-202305-15-202305-24-2023Class II236,610 vialsAmpicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20Terminated

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.