FDA-Drug2023-01-18Class II

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.

Northern VA Compounders PLLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
525 vials
Manufactured in
23475 Rock Haven Way, Suite 105, Sterling, VA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0117-2023

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