Albuterol - tube - 0 recalled over sterility concerns
- Recall date
- December 22, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pharmacy Innovations recalls Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17…
- Recall number
- D-0192-2023
- FDA classification
- Class II
- Brand / firm
- Pharmacy Innovations
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
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