D-0334-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- January 19, 2018
- Termination Date
- September 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
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.
Distribution Pattern
Product was distributed U.S.A. nationwide.
Code Information
all lots