FDA recall D-0123-2023

Northern VA Compounders PLLC · Class II · drug

Product

TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/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

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-0123-2023