The Recall Desk
SevereFDA (Drugs)·D-0335-2018·Announced 2018-02-14

Flawless Beauty Recalls Unapproved Glutathione Whitening Injection Kits

Flawless Beauty LLC is voluntarily recalling all lots of TAD Glutathione Whitening Kits because the products were marketed without FDA approval.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score under the rubric.

Plain-English summary

Flawless Beauty LLC is voluntarily recalling all lots of TAD Glutathione Whitening Kits, which contain lyophilized powder for injection. The products were sold individually or as part of multi-unit kits and were distributed nationwide in the United States.

The recall is being conducted in accordance with a Consent Decree of Permanent Injunction ordered by the United States District Court. The agency determined that the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), constituting misbranding and unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.

Consumers who possess these products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Flawless Beauty LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →