Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistClinical Formula LLC manufactured and distributed Clinical Formula™ Bleaching Lotion, an unapproved new drug product intended for skin bleaching and lightening that violated section 505(a) of the FD&C Act and was misbranded under section 502(ee). The product contained hydroquinone 2% and made explicit claims on its label for bleaching hyperpigmented skin conditions such as melasma and freckles, establishing it as a drug requiring FDA approval prior to marketing. The company introduced this unapproved drug product into interstate commerce without an approved new drug application, which is prohibited under the FD&C Act.