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Elanco Animal Health USA was cited for false and misleading promotional claims about Pradalex (pradofloxacin injection), an animal drug used to treat bovine respiratory disease in cattle, which misbranded the product in violation of the Federal Food, Drug, and Cosmetic Act sections 502(a), 502(n), and 201(n). The violations were found across multiple promotional materials including print advertisements, detail aids, a cattle technical manual, and a promotional video that made unsupported safety and effectiveness claims about the drug. The FDA emphasized particular concern due to pradofloxacin belonging to the fluoroquinolone drug class, which is considered critically important for human medicine, making inappropriate animal use claims especially problematic from a public health perspective.