Drug & medication recalls Moderate risk

Trimix 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 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharm…
Recall number
D-1126-2015
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

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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