D-0195-2020 Class II Terminated
FDA drug recall D-0195-2020 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: 25 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
- 25 bottles
Product Description
BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. 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: 1902411.25
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0195-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026