Flawless Beauty Recalls Relumins Advanced Glutathione Kits Nationwide
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Advanced Glutathione kits nationwide because the products were marketed without FDA approval.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves unapproved new drugs marketed without FDA approval.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Advanced Glutathione kits, including 900 mg, 1500 mg, and 3000 mg vials, sold individually or as part of multi-unit kits. The recall is being conducted in accordance with a Consent Decree of Permanent Injunction ordered by the United States District Court.
The FDA determined that the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This constitutes misbranding and the distribution of unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act.
The product was distributed nationwide in the United States. Consumers should stop using the recalled products and contact the manufacturer for further instructions.
The recalled product
- Product
- Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
- 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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