FDA (Drugs) recall action 78991
The FDA (Drugs) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
The agency’s own wording, quoted from the enforcement report.
Flawless Beauty LLC is voluntarily recalling Laennec INJ placenta extract vials because they were marketed without FDA approval.
Flawless Beauty LLC is voluntarily recalling Tatiomax Glutathione Whitening kits nationwide because the products were marketed without FDA approval.
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.
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules because they were marketed without an approved NDA or ANDA.
Flawless Beauty LLC is voluntarily recalling all lots of Laroscorbine Platinum Vitamin C products because they were marketed without an approved NDA or ANDA.
Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections sold in the U.S. because the products were marketed without FDA approval.
Flawless Beauty LLC is voluntarily recalling all lots of TAD Glutathione Whitening Kits because the products were marketed without FDA approval.
Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules because they were marketed without an approved NDA/ANDA, constituting misbranding and unapproved new drugs.
Flawless Beauty LLC is voluntarily recalling all lots of Reiki Glutathione Whitening kits because they were marketed without an approved NDA or ANDA.
Flawless Beauty LLC is voluntarily recalling all lots of TP Drug Laboratories Vitamin C ampules nationwide because they were marketed without an approved NDA/ANDA.
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).
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Advanced Glutathione kits nationwide because the products were marketed without FDA approval.