PlainRecalls
FDA Drug Moderate Class II Terminated

TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy

Reported: February 14, 2018 Initiated: January 19, 2018 #D-0335-2018

Product Description

TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy

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?
TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy. 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-0335-2018.