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Recall Observatory FDA recall evidence

Drug product

BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

D-0197-2020

October 18, 2019

Class II

Product summary

Firm
Basic Reset Inc.
Event
Event 83997
Status
Terminated
Classification
Class II
Quantity
25 bottles
Official record key
drug-enforcement:D-0197-2020

Official wording

Reason: Marketed without an Approved NDA/ANDA

Code information: Lot: 1902411.25

Distribution pattern: United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA