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Save Rite Medical was cited for distributing unapproved new drugs and misbranded products in violation of the Federal Food, Drug, and Cosmetic Act by selling triclosan-containing antimicrobial lotion soaps (Ameriderm AmeriWash products in 800 mL and 1000 mL sizes) through their website without FDA approval. The products were marketed with antimicrobial and healthcare-related claims that established them as drugs intended to affect body structure or function, yet they lacked the required new drug application approval and proper drug labeling. The FDA identified these violations through a website review of saveritemedical.com, determining the products were unapproved new drugs introduced into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act and were misbranded under section 502(ee).