US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 15, 2023 (3 years ago)

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

What was recalled

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

Recalling firm
Astral SteriTech Private Ltd.
NDC code
70594-083-01
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0603-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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