Mitomycin Solution Injectable recalled over sterility concerns

Recall date

September 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Wells Pharmacy Network LLC recalls Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL

Recall number

D-0377-2017

FDA classification

Class II

Brand / firm

Wells Pharmacy Network LLC

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

Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL