Status
Terminated
Drug Enforcement D-0224-2023
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Classification
Class II
Report Date
February 1, 2023
Termination Date
July 31, 2024
Product Information
- Product description
- 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.
- Product quantity
- N/A
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Pharmacy Innovations
- Address
-
2936 W 17th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0224-2023
- Event ID
- 91332
- Recall initiation date
- December 22, 2022
- Center classification date
- January 26, 2023
- Code info
- t20221108@20 t20221026@25 t20221116@36
- More code info
- —