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Ultimark Products distributed Porcelana Day Skin Lightening Cream, an unapproved new drug containing 2% hydroquinone that was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The product was marketed with drug claims on its label and website (including "skin lightener," "fades dark spots," and "gradual fading of dark spots") without FDA approval, violating section 505(a) of the FD&C Act and misbranding provisions under section 502(ee). The company introduced and distributed the product into interstate commerce without the required new drug application approval.