Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs
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 email@example.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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.html
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.html or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being made with the knowledge of the Food and Drug Administration.