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, Mfd for Meitheal Pharmaceuticals Chicago, IL 6…
- Recall number
- D-0592-2023
- 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, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
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