PlainRecalls
FDA Drug Moderate Class II Terminated

Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC

Reported: February 14, 2018 Initiated: January 19, 2018 #D-0334-2018

Product Description

Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC

Reason for Recall

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Details

Recalling Firm
Flawless Beauty LLC
Units Affected
N/A
Distribution
Product was distributed U.S.A. nationwide.
Location
Asbury Park, NJ

Frequently Asked Questions

What product was recalled?
Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC. Recalled by Flawless Beauty LLC. Units affected: N/A.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 14, 2018. Severity: Moderate. Recall number: D-0334-2018.