D-0106-2023 Class II Terminated
FDA drug recall D-0106-2023 was initiated by Northern VA Compounders PLLC on December 30, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 21, 2023). Affected quantity: 750 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 18, 2023
- Initiation Date
- December 30, 2022
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 750 vials
Product Description
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: 11142022@17, Exp 12/29/2022; 11262022@7, Exp 1/10/2023; 12022022@3, Exp 1/16/2023