Glutathione INHALATION recalled over sterility concerns
- Recall date
- May 15, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Montana Compounding Pharmacy recalls Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy,…
- Recall number
- D-1122-2015
- FDA classification
- Class II
- Brand / firm
- Montana Compounding Pharmacy
- Sold / distributed
- MT and ND
Why it was recalled
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
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