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PurePurge Inc. was cited for marketing MEDPURE HAND SANITIZER products as unapproved new drugs in violation of section 505(a) of the FD&C Act and for misbranding violations under sections 502(ee) and (o). The FDA determined that the products qualified as drugs based on labeling claims identifying them as hand sanitizers intended to reduce bacteria on skin, yet the company had not obtained FDA approval before introducing them into interstate commerce. The violations were identified during an FDA review of the company's websites (purepurge.com and medpure.store) conducted on February 11, 2021.