Ampicillin and Sulbactam for Injection recalled over sterility concerns
- Recall date
- May 15, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Astral SteriTech Private Ltd. recalls Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharm…
- Recall number
- D-0603-2023
- FDA classification
- Class II
- Brand / firm
- Astral SteriTech Private Ltd.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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
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