PlainRecalls
FDA Drug Moderate Class II Terminated

Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.

Reported: February 14, 2018 Initiated: January 19, 2018 #D-0328-2018

Product Description

Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.

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?
Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.. 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-0328-2018.