pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LL...
FDA Recall #D-0080-2026 — Class II — July 30, 2025
Product Description
pH Buffered Reconstitution 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 Medical Health Institute (MHI), 10mL.
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