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Amazon.com, Inc. distributed three unapproved injectable lipolytic drug products—"LemonBottle Ampoule Solution," "L-Carnitine Body Serum Ampoule," and "Matrigen PPC Ampoule"—through its website and Fulfillment by Amazon service, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were marketed with drug claims (diagnosis, cure, mitigation, treatment, or prevention of disease, or affecting body structure/function) but lacked FDA approval as new drugs. The violations were particularly concerning because injectable products bypass the body's natural defenses and carry risks of serious harm including infection and life-threatening conditions.