FDA recall D-0189-2020

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