FDA recall D-0190-2020

Basic Reset Inc. · Class II · drug

Product

Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075

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-0190-2020