Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N...
FDA Recall #D-0081-2026 — Class II — July 30, 2025
Product Description
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
GenoGenix LLC — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
US Nationwide.
Code Information
All lots within expiry.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated