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COMPANY ANNOUNCEMENT

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Reason for Announcement:
Recall Reason Description
Unapproved Drugs
Company Name:
Flawless Beauty, LLC
Brand Name:
Brand Name(s)
Several brands
Product Description:
Product Description
Unapproved new drugs

Company Announcement

In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks. To date, Flawless Beauty has not received any reports of adverse events related to this recall.

The following products are subject to the recall and were sold and distributed over the Internet to U.S. and foreign customers. The web site of Flawless Beauty is www.flawlessbeautyandskin.com. All glutathione products were sold in multi-vial whitening kits, either alone or in combination with ampules of vitamin C and sterile water. Vials or ampules of vitamin C or sterile water purchased separately or as part of these whitening kits are also recalled:

Relumins Advanced Glutathione kits w/ 900mg vials
Relumins Advanced Glutathione kits w/ 1500mg vials
Relumins Advanced Glutathione kits w/ 3000 vials
Relumins Vitamin C Solvent ampules
Tatiomax Gluatathione Whitening kits w/ 1400mg vials
Saluta Glutathione Whitening kits w/ 600mg vials
Saluta Glutathione Whitening kits w/ 1200mg vials
Saluta Glutathione Whitening kits w/ 1800mg vials
Laroscorbine Platinum Vitamin C with Collagen – 1100mg
Tationil Glutathione Whitening 10 vial kits
Tationil Glutathione Whitening (5 sets of 10 vial kits)
Laennec Human Placenta Whitening kits – 2ml vials
Reiki Glutathione Whitening kits
TAD Glutathione Whitening kits w/ 600mg vials
TP Drug Laboratories Vitamin C ampules
Sterile water ampules
Ling Zhi capsules
 

Flawless Beauty is notifying its customers by sending recall letters and is arranging for return of all recalled products. Consumers, distributors & retailers that have the products which are being recalled should stop using & return to Flawless Beauty.

Consumers with questions regarding this recall can contact Flawless Beauty by phone at 1-917-831-5948 or jack@flawlessbeautyandskin.com on Monday-Friday, 9:30AM – 5:30 PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being made with the knowledge of the Food and Drug Administration.


Company Contact Information

Consumers:
Jack Gindi
1-917-831-5948
jack@flawlessbeautyandskin.com
Media:
Jack Gindi
1-917-831-5948
jack@flawlessbeautyandskin.com