Flawless Beauty Recalls Reiki Glutathione Whitening Kits for Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of Reiki Glutathione Whitening kits because they were marketed without an approved NDA or ANDA.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant regulatory violations involving unapproved drugs.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Reiki Glutathione Whitening kits. 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
- Reiki Glutathione Whitening kits
- 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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