Ampicillin 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 for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 1…
- Recall number
- D-0584-2023
- 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 for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15
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