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
Recalled October 19, 2016 · FDA recall D-0015-2017 · Leiter's Compounding
Hazard
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters · FDA Class II
Units
76,315 total units, all products
Sold at
Nationwide
Description
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Product
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
Manufacturer(s)
Leiter's Compounding
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →