Flawless Beauty Recalls Unapproved Glutathione Injectable Products Nationwide
Flawless Beauty LLC is voluntarily recalling all lots of Tationil Glutathione and other products sold in kits. The recall is due to misbranding and the sale of unapproved new drugs under a court order.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving unapproved new drugs which carry inherent risks of unknown safety profiles.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Tationil Glutathione, 600 mg/ 4 mL, powder and solvent for injectable solution, as well as other products sold individually or in multi-unit kits. The products 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 action addresses violations of the Federal Food, Drug, and Cosmetic Act, specifically regarding misbranding and the marketing of unapproved new drugs without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who possess these products should stop using them immediately. Because the products are unapproved new drugs, they have not been evaluated by the FDA for safety or effectiveness. Individuals should consult their healthcare provider for guidance on what to do with the recalled items.
The recalled product
- Product
- Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Unapproved New Drug
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.
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