Recalls / Class II
Class IID-0330-2018
Product
Reiki Glutathione Whitening kits
- Affected lot / code info
- all lots
Why it was recalled
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.
Recalling firm
- Firm
- Flawless Beauty LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1215 Main St, N/A, Asbury Park, New Jersey 07712-5940
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed U.S.A. nationwide.
Timeline
- Recall initiated
- 2018-01-19
- FDA classified
- 2018-02-05
- Posted by FDA
- 2018-02-14
- Terminated
- 2018-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0330-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.