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 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA…
- Recall number
- D-0596-2023
- 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 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
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