Drug product
Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
D-0324-2018
Product summary
- Event
- Event 78991
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0324-2018
Official wording
Reason: 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.
Code information: all lots
Distribution pattern: Product was distributed U.S.A. nationwide.
Derived failure modes
-
Labeling or packaging
misbranding