Drug & medication recalls Moderate risk

TriMix recalled over sterility concerns

Recall date
November 17, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Tri-Coast Pharmacy recalls TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Recall number
D-0310-2017
FDA classification
Class II
Brand / firm
Tri-Coast Pharmacy
Sold / distributed
Nationwide

Why it was recalled

Lack of Assurance of Sterility

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, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

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