Status
Terminated
Drug Enforcement D-0102-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
January 18, 2023
Termination Date
June 21, 2023
Product Information
- Product description
- 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.
- Product quantity
- 2 vials
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Northern VA Compounders PLLC
- Address
-
23475 Rock Haven Way, Suite 105
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0102-2023
- Event ID
- 91443
- Recall initiation date
- December 30, 2022
- Center classification date
- January 12, 2023
- Code info
- Lot#: 12062022@7, Exp 1/20/2023; 12072022@32, Exp 1/22/2023
- More code info
- —