FDA recall D-0194-2020

Basic Reset Inc. · Class II · drug

Product

Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 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-0194-2020