PlainRecalls
FDA Drug Moderate Class II Terminated

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

Reported: May 24, 2023 Initiated: May 15, 2023 #D-0594-2023

Product Description

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
35,087 bottles
Distribution
Nationwide within the United States
Location
Vadodara, N/A

Frequently Asked Questions

What product was recalled?
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75. Recalled by Astral SteriTech Private Ltd.. Units affected: 35,087 bottles.
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-0594-2023.