FDA Warns OTC Manufacturer for Differences Between Electronic Records, Labeling

The FDA issued a warning letter to Ami Cosmetics in Soeul, South Korea, saying the over-the-counter drugmaker had contradictory information in its labeling and its electronic listing in the FDA’s National Drug Code directory.

A review of the listing for the company’s PureHeals Centella 70 Toning Swab found the drug data in the electronic listing file did not match that of the labeling included with it, apparently referring to an entirely different product.

“Specifically, the product’s proprietary name of ‘PureHeals Centella 70 Toning Swab’ does not match the proprietary name of ‘Jeju: En Black Bean Ferment Emulsion,’ which appears on the carton label image provided with the listing file,” the agency said.