Recalls / Class II
Class IID-0196-2020
Product
BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
- Affected lot / code info
- Lot: 1903011.80
Why it was recalled
Marketed without an Approved NDA/ANDA
Recalling firm
- Firm
- Basic Reset Inc.
- Notification channel
- Letter
- Type
- FDA Mandated
- Address
- 260 W Main St Ste 103, N/A, Hendersonville, Tennessee 37075-7316
Distribution
- Quantity
- 25 bottles
- Distribution pattern
- United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece
Timeline
- Recall initiated
- 2019-10-18
- FDA classified
- 2019-11-05
- Posted by FDA
- 2019-11-13
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0196-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.