Mitomycin 0 recalled over sterility concerns

Recall date

September 20, 2016

Source

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

Official notice title

Leiter's Compounding recalls Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative F…

Recall number

D-0015-2017

FDA classification

Class II

Brand / firm

Leiter's Compounding

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

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 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35