FDA-Drug2025-10-15Class II
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.
Hazard
Lack of Assurance of Sterility
Sold states
US Nationwide.
Manufactured in
2840 Nw 2nd Ave Ste 204, Boca Raton, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0074-2026Want us to check the next one for you?
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