Why it was recalled
Marketed without an Approved NDA/ANDA
Product description
BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
Lot numbers, UPCs & expiration codes
Lot: 1903011.80
Where it was sold
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0196-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 18, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 25 bottles
- Recall type
- FDA Mandated
- Recalling firm
- Basic Reset Inc.
Original FDA data
Every field from FDA enforcement report D-0196-2020, exactly as published.
Show all FDA fields
- City
- Hendersonville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 83997
- Address
- 260 W Main St Ste 103
- Code information
- Lot: 1903011.80
- Postal code
- 37075-7316
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0196-2020
- Classification
- Class II
- Recalling firm
- Basic Reset Inc.
- Product quantity
- 25 bottles
- Termination date
- Oct 27, 2021
- Reason for recall
- Marketed without an Approved NDA/ANDA
- Voluntary / mandated
- FDA Mandated
- Product description
- BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
- Distribution pattern
- United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece
- Recall initiation date
- Oct 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2019