FDA-Drug2016-10-19Class II
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
Leiter's Compounding
Hazard
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Sold states
Nationwide
Affected count
76,315 total units, all products
Manufactured in
17 Great Oaks Blvd, N/A, San Jose, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0015-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief