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Talk to a SpecialistTalk to a SpecialistDermacare dba Filler Outlet was cited for introducing unapproved and misbranded injectable botulinum toxin (Botox) products into interstate commerce through its website www.filleroutlet.com, violating sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's products lacked FDA approval and proper labeling, posing serious safety risks to consumers including potential contamination, counterfeit formulations, inconsistent active ingredient amounts, and life-threatening conditions such as sepsis from injectable drug administration. The FDA requested immediate cessation of all unapproved and misbranded drug sales to protect public health.