QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL...
FDA Recall #D-0107-2023 — Class II — December 30, 2022
Product Description
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/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
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
39 vials
Distribution
Nationwide in the USA
Code Information
Lot#: 11162022@10, Exp 12/31/2022; 12052022@9, Exp 1/19/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated