FDA Recall Terminated Historical recordClass 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
- Reason
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Published
- October 19, 2016
- Distribution
- Nationwide
