Loading…
FishMoxFishFlex/Simple Pet Health LLC distributed unapproved animal drugs including amoxicillin, azithromycin, cephalexin, ciprofloxacin, clindamycin, doxycycline, metronidazole, penicillin, and sulfamethoxazole/trimethoprim products intended for aquarium fish and birds through their website. The company violated the Federal Food, Drug, and Cosmetic Act by distributing these drugs without FDA approval and without registering their manufacturing facilities with the agency, making the products both unapproved new animal drugs and misbranded under sections 301(a), 502(o), 510(b), and 510(j) of the Act. The FDA identified multiple disease treatment and prevention claims on the company's website that established the products' intended use as drugs rather than dietary supplements or other non-drug products.