FDA-Drug2023-05-24Class II

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

Astral SteriTech Private Ltd.
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
35,087 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, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2023

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