Home / Recalls / Northern VA Compounders PLLC / D-0107-2023

D-0107-2023 Class II Terminated

Recalled by Northern VA Compounders PLLC — Sterling, VA

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
39 vials

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot#: 11162022@10, Exp 12/31/2022; 12052022@9, Exp 1/19/2023

Other recalls by Northern VA Compounders PLLC

  • D-0109-2023 Class II — Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Do (December 30, 2022)
  • D-0126-2023 Class II — TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL I (December 30, 2022)
  • D-0114-2023 Class II — TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL I (December 30, 2022)
  • D-0102-2023 Class II — Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx (December 30, 2022)
  • D-0118-2023 Class II — TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/ (December 30, 2022)
  • D-0106-2023 Class II — TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/m (December 30, 2022)
  • D-0113-2023 Class II — TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL I (December 30, 2022)
  • D-0115-2023 Class II — TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL I (December 30, 2022)
  • D-0117-2023 Class II — TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL IN (December 30, 2022)
  • D-0121-2023 Class II — TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABL (December 30, 2022)