FDA recall D-0188-2020

Basic Reset Inc. · Class II · drug

Product

Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.

Reason for recall

Marketed without an Approved NDA/ANDA

Distribution

United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

Key facts

Status
Terminated
Initiation date
2019-10-18
Report date
2019-11-13
Termination date
2021-10-27
Voluntary/Mandated
FDA Mandated
Location
Hendersonville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0188-2020