FDA-Drug2023-05-24Class II

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01

Astral SteriTech Private Ltd.
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
23,187 bottles
Manufactured in
911 G I D C Makarpura, N/A, Vadodara, N/A, India
Products
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0603-2023

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