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Plakini Pharma's website (www.plakini-pharma.com) was found to be unlawfully selling unapproved and misbranded drugs—specifically opioids, benzodiazepines, and Schedule II stimulants—directly to U.S. consumers over the internet in violation of the Federal Food, Drug, and Cosmetic Act sections 301(a), 301(d), 503(b), and 505(a). The violations involved introducing these controlled substances into interstate commerce without FDA approval and without proper labeling as required by law. The FDA emphasized the particular public health concern given the ongoing opioid epidemic and the high abuse potential of benzodiazepines and stimulants, especially when co-used with other substances, which significantly increases overdose risk.