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
Recall initiated: 20250730
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated