Flawless Beauty LLC is recalling all lots of 19 different skin whitening products sold individually or as part of multi-unit kits because they violate federal law and pose serious health risks to consumers, the Food and Drug Administration (FDA) said in a Safety Communication.
The recall is being conducted in accordance with a Consent Decree of Permanent Injunction which was ordered in the U.S. District Court for the District of New Jersey. The company is accused of making claims about the products that violate the Federal Food, Drug and Cosmetic Act.
The recall includes all products containing glutathione sold in multi-vial skin whitening kits, either alone or in combination with ampules of vitamin C and sterile water. Vials or ampules or sterile water purchased separately or as part of these whitening kits are also being recalled.
Affected products include Relumins Advanced Glutathione kits with 900mg vials, 1500mg vials, and 3000mg vials; Relumins Vitamin C Solvent ampules; Tatiomax Glutathione Whitening kits with 1400mg vials; Saluta Gluatathione with kits with 600mg vials, 1200mg vials, and 1800mg vials; Laroscorbine Platinum Vitamin C with Collagen 1100mg; Tationil Gluatathione Whitening 10 vial kits, and 5 sets of 10 vial kits; Laennec Human Placenta Whitening Kits 2ml vials; Reiki Gluatathione Whitening kits; TAD Gluatathione Whitening kits with 600mg vials; TP Drug Laboratories Vitamin C ampules; Sterile water ampules; and Ling Zhi capsules.
Flawless Beauty is arranging for the return of all recalled products. Consumers with these products should stop using them and return them to the company. Consumers with questions can call Flawless Beauty at 917-831-5948.
Consumers who experience any side effects after using any of these products should contact their doctors as well as file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice