FDA states company sold unapproved and improperly labeled drugs that present serious public health risks, particularly sterile injectable skin whitening drug products.
A New Jersey company that sold injectable skin whitening and other beauty products has been ordered to stop selling and recall some of its products because they are unapproved new drugs that are potentially unsafe to consumers, according to the FDA's press release.
US District Judge Peter G. Sheridan entered a consent decree of permanent injunction between the United States and Flawless Beauty LLC of Ocean Township and Asbury Park, New Jersey, the company’s co-owners, Jack H. Gindi and Susana B. Boleche, and an affiliated company owned by Mr. Gindi, RDG Imports LLC.
According to the complaint, the company sold unapproved and improperly labeled drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products. However, intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks, such as nerve or blood vessel damage, infection, or toxic systemic reactions.
Additionally, Flawless Beauty sold products labeled to contain human placenta, which can cause serious illness. The company also falsely implied FDA approval or endorsement for some of the products sold.
As a result of the consent decree, Flawless Beauty, RDG Imports, and its owners are prohibited from directly or indirectly importing, manufacturing, and/or distributing any drug products until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). They must also hire an expert to review their drug products and receive written permission from the FDA before they are allowed to resume operations.
The company has 20 days to recall all ampules or lyophilized vials, which includes products sold under the Relumins, Tatiomax, TP Drug Laboratories, Laennec, Saluta, Tationil, and Laroscorbine brands.
US Marshals previously seized several unapproved and misbranded drug products sold and distributed by Flawless Beauty in September, 2014. Despite this, the company and its owners continued to market and distribute unapproved drugs.
Health care professionals and consumers are urged to report any adverse events related to products sold by Flawless Beauty to its MedWatch Adverse Event Reporting program.
Federal judge orders Flawless Beauty to stop distributing unapproved drugs, recall certain products [news release]. FDA's website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577565.htm. Accessed September 26, 2017.