Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSilver Lease, LLC manufactured and distributed unapproved veterinary antimicrobial drugs (Fishbiotic Cephalexin, Doxycycline, and SMZ/TMP) intended for treating bacterial infections in aquarium fish without FDA approval or facility registration. The products violated the Federal Food, Drug, and Cosmetic Act by making disease treatment claims on their labels while failing to comply with drug listing requirements under sections 510(b) and (j), and were misbranded under section 502(o). The FDA identified these violations through website reviews of authorized distributors (Allivet.com and Lambertvet supply.com) in August 2023, where the product labels explicitly claimed uses for conditions including fin rot, pop-eye, and columnaris disease.