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Recall Observatory FDA recall evidence

Drug product

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075

D-0189-2020

October 18, 2019

Class II

Product summary

Firm
Basic Reset Inc.
Event
Event 83997
Status
Terminated
Classification
Class II
Quantity
1000 bottles
Official record key
drug-enforcement:D-0189-2020

Official wording

Reason: Marketed without an Approved NDA/ANDA

Code information: Lots: 28917A, 23918A, 21519A

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