FDA recall D-0185-2023
Pharmacy Innovations · Class II · drug
Product
Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason for recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2022-12-22
- Report date
- 2023-02-01
- Termination date
- 2024-07-31
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Erie, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0185-2023