Flawless Beauty Recalls Relumins Vitamin C Ampules for Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules because they were marketed without an approved NDA or ANDA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a voluntary action to address regulatory misbranding and unapproved status, without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules. The product was sold individually or as part of multi-unit kits and was 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 Flawless Beauty LLC for further instructions regarding the recall.
The recalled product
- Product
- Relumins Vitamin C Solvent ampules
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Topical / Cosmetic
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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