Flawless Beauty Recalls Unapproved Saluta Glutathione Whitening Kits Nationwide
Flawless Beauty LLC is voluntarily recalling all lots of Saluta Glutathione Whitening kits nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (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 source explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe).
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Saluta Glutathione Whitening kits. These products are packaged in 600 mg, 1200 mg, and 1800 mg glass vials and were manufactured by Shandong Luye Pharmaceutical Co, Ltd in Yantai, Shandong, PRC. The kits were sold individually or as part of multi-unit packages.
The recall is being conducted in accordance with a Consent Decree of Permanent Injunction ordered by the United States District Court. The products are being recalled due to misbranding and because they are unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. Specifically, the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was distributed nationwide in the United States. Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
- 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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