FDA recall D-0015-2017

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-09-20

Report date

2016-10-19

Termination date

2017-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0015-2017