D-0189-2020 Class II Terminated
FDA drug recall D-0189-2020 was initiated by Basic Reset Inc. on October 18, 2019 and is designated Class II. Reason for recall: Marketed without an Approved NDA/ANDA The recall status is terminated (terminated October 27, 2021). Affected quantity: 1000 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- October 18, 2019
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1000 bottles
Product Description
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 Pattern
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece
Code Information
Lots: 28917A, 23918A, 21519A