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 (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharm…

Recall number

D-1125-2015

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 (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.