Ethanol for Injection 95% recalled over sterility concerns
- Recall date
- May 24, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- US Specialty Formulations LLC recalls Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allento…
- Recall number
- D-0986-2022
- FDA classification
- Class II
- Brand / firm
- US Specialty Formulations LLC
- Sold / distributed
- Product was distributed to medical facilities and a physician's office Nationwide in the USA.
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
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
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