FDAHealthJuly 30, 2025
GenoGenix LLC — Elite Stack 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
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 30, 2025
US Nationwide.
What's affected?
- Product
- Elite Stack 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 and Medical Health Institute (MHI).
- Brand
- GenoGenix LLC
- Lot code
- within
Additional details
All lots within expiry.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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