Drug & medication recalls Moderate risk

Bimix 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 Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compoundin…
Recall number
D-1120-2015
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

Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

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