PlainRecalls
FDA Drug Moderate Class II Terminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41

Reported: May 24, 2023 Initiated: May 15, 2023 #D-0596-2023

Product Description

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
58,770 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, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41. Recalled by Astral SteriTech Private Ltd.. Units affected: 58,770 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-0596-2023.