Alprostadil 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 Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Mi…
- Recall number
- D-1128-2015
- 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
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
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