FDA Drug Class II — Moderate

Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Brand
Wells Pharmacy Network LLC
UPC
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@84, 07012016@107. Known vial lot code: 04212016@149, 06082016@7.

Units Affected

315 kits (number of vials per kit vary by prescription)