FDA recall D-0189-2020

Basic Reset Inc. · Class II · drug

Product

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset 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-0189-2020