FDA Recall Terminated Historical recordClass II
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Reason
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Published
- February 1, 2023
- Distribution
- Nationwide
