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Midland Vet Services manufactured and distributed unapproved antimicrobial drugs marketed for aquarium fish and birds (including Aqua-Mox, Aqua-Cipro, Aqua-Doxy, and others) without FDA approval or facility registration. The products were misbranded under federal law because they made disease treatment and prevention claims that classified them as drugs, but were neither drug-listed with FDA nor manufactured in an FDA-registered facility. The company introduced these unapproved new animal drugs into interstate commerce through major online retailers including Chewy.com, FishIck.com, Heartland Vet Supply, and Jeffers Pet, in violation of the Federal Food, Drug, and Cosmetic Act.