PlainRecalls
FDA Drug Moderate Class II Terminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

Reported: May 24, 2023 Initiated: May 15, 2023 #D-0592-2023

Product Description

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
236,610 vials
Distribution
Nationwide within the United States
Location
Vadodara, N/A

Frequently Asked Questions

What product was recalled?
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20. Recalled by Astral SteriTech Private Ltd.. Units affected: 236,610 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0592-2023.