FDAFDA · Food and drugs·Recall number D-0224-2023
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.
Published February 1, 2023 · Recall initiated: December 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Pharmacy Innovations
- Distributor
- Nationwide in the USA
- Lot
- t20221108@20 t20221026@25 t20221116@36
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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