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DirectPharmashop.net, an online pharmacy operating from the Netherlands, was cited for unlawfully introducing unapproved and misbranded drugs into U.S. interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (sections 301(a), 301(d), 301(k), 503(b), and 505(a)). Specifically, the website offered unapproved aripiprazole products and misbranded quetiapine products to U.S. consumers without FDA approval or proper labeling. The FDA emphasized that unapproved drugs bypass critical regulatory safeguards and may be contaminated, counterfeit, or contain inconsistent or undisclosed active ingredients, posing significant health risks to consumers. The agency directed the company to immediately cease offering any unapproved and misbranded drugs for sale to U.S. consumers.