D-0189-2020 Class II Terminated
FDA drug recall D-0189-2020 was initiated by Basic Reset Inc. on Oct 18, 2019 and is designated Class II. Reason for recall: Marketed without an Approved NDA/ANDA The recall status is terminated (terminated Oct 27, 2021). Affected quantity: 1000 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 13, 2019
- Initiation Date
- Oct 18, 2019
- Termination Date
- Oct 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0189-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026