Recall D-0074-2026

US Class II Ongoing · initiated 2025-07-30

Recalling firm

GenoGenix LLC, FL

Product

Elite Stack MSC Exosome 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 Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial.

Reason for recall

Lack of Assurance of Sterility

← All recalls