FDAHealthJuly 30, 2025
GenoGenix LLC — Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
⚠️ 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
- Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
- Brand
- GenoGenix LLC
- Lot code
- GG053025-002
Additional details
Lot#: GG053025-002 within expiry
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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