03.01.18
In accordance with a Consent Decree of Permanent Injunction ordered in the US District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of 19 different products sold individually or as part of multi-unit kits alleged by the US 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.
Select products are subject to the recall and were sold and distributed over the internet to US and foreign customers. The Flawless Beauty website 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.
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 at www.flawlessbeautyandskin.com, by regular mail or by fax.
The FDA also recalled two hair products made by Avlon Industries, Inc. of Melrose Park, IL.
The company’s KeraCare Hydrating Detangling Shampoo-Sulfate-free (8oz., and gallons; 8 oz.-12 bottles/case; gallons- 4 per case; UPC: 9670838012, Item #53227; UPC: 9670833053, Item #53943) is being recalled due to the presence of Enterobacter cloacae. According to the company, two lots are included in this recall—828 units in Lot 16G1503 and 3,984 units in Lot 16K3l03.
The firm’s As I am Born Curly Argan Curl Defining Jelly (8 oz., 12 bottles/case, packaged in an amber bottle with a teal pump) is being recalled due to the presence of Enterobacter gergoviae. According to FDA, 156 units are being recalled.
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.
Select products are subject to the recall and were sold and distributed over the internet to US and foreign customers. The Flawless Beauty website 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.
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 at www.flawlessbeautyandskin.com, by regular mail or by fax.
The FDA also recalled two hair products made by Avlon Industries, Inc. of Melrose Park, IL.
The company’s KeraCare Hydrating Detangling Shampoo-Sulfate-free (8oz., and gallons; 8 oz.-12 bottles/case; gallons- 4 per case; UPC: 9670838012, Item #53227; UPC: 9670833053, Item #53943) is being recalled due to the presence of Enterobacter cloacae. According to the company, two lots are included in this recall—828 units in Lot 16G1503 and 3,984 units in Lot 16K3l03.
The firm’s As I am Born Curly Argan Curl Defining Jelly (8 oz., 12 bottles/case, packaged in an amber bottle with a teal pump) is being recalled due to the presence of Enterobacter gergoviae. According to FDA, 156 units are being recalled.