FDA-Drug2023-05-24Class II

Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41

Astral SteriTech Private Ltd.
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
91,860 vials
Manufactured in
911 G I D C Makarpura, N/A, Vadodara, N/A, India
Products
Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0600-2023

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