Recall Record

Hendersonville, TN, United States

Basic Reset Inc. recalls

3 recalls recorded since 2018, most recently on 18 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0

Terminated Class II Drugs

Recall started
18 October 2019
Terminated
27 October 2021
Reason
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
Initiated
FDA Mandated
Recall numbers
D-0188-2020, D-0192-2020, D-0189-2020, D-0187-2020, D-0193-2020, D-0191-2020, D-0196-2020, D-0190-2020, D-0195-2020, D-0197-2020, D-0194-2020

Completed Class II Medical devices

Recall started
18 October 2019
Reason
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Distribution
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Initiated
FDA Mandated
Recall number
Z-0348-2020

Terminated Class II Food

Recall started
23 September 2019
Terminated
19 August 2020
Reason
Products do not conform to Dietary Supplement CGMP regulations.
Distribution
Product was shipped to all 50 states. Product was shipped to the following foreign consignees: Canada, Nigeria, U.K., Australia, Israel, Puerto Rico, Virgin Islands, Hungary, UAE, Mexico, Philippines, Greece, and Puerto Rico.
Initiated
FDA Mandated
Recall numbers
F-0174-2020, F-1239-2020, F-0173-2020, F-0179-2020, F-0171-2020, F-0177-2020, F-0175-2020, F-0172-2020, F-0180-2020, F-0176-2020, F-0182-2020, F-0170-2020 and 2 more

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.