FDA recall D-0102-2023
Northern VA Compounders PLLC · Class II · drug
Product
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2022-12-30
- Report date
- 2023-01-18
- Termination date
- 2023-06-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Sterling, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2023