Status
Terminated
Drug Enforcement D-0117-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
January 18, 2023
Termination Date
June 21, 2023
Product Information
- Product description
- TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
- Product quantity
- 525 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-0117-2023
- Event ID
- 91443
- Recall initiation date
- December 30, 2022
- Center classification date
- January 12, 2023
- Code info
- Lot#: 11252022@5, Exp 1/9/2023; 12012022@12, Exp 1/15/2023
- More code info
- —