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Tramadol US was cited for unlawfully selling unapproved and misbranded opioid and benzodiazepine drugs to U.S. consumers over the internet, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's unapproved drugs lacked FDA safety and efficacy assurances and posed risks of contamination, counterfeiting, or variable ingredient content. The FDA emphasized particular concern given the ongoing opioid epidemic and the public health dangers of internet availability of controlled substances, especially benzodiazepines that are frequently co-used with other drugs and alcohol, leading to severe overdose outcomes.