Drug product
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
D-0090-2026
Product summary
- Firm
- GenoGenix LLC
- Event
- Event 97369
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0090-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: GG062425-002 within expiry.
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility