TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 m...
FDA Recall #D-0116-2023 — Class II — December 30, 2022
Product Description
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 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
Recalling Firm
Northern VA Compounders PLLC — Sterling, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4 vials
Distribution
Nationwide in the USA
Code Information
Lot#: 11212022@7, Exp 1/5/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated