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Class II: temporary or reversible health riskTerminated

Basic Reset Nuovi Skin Toner Recall

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL

Basic Reset Inc. · Hendersonville, TN

Risk level
Class II
Reported by FDA
Nov 13, 2019
Recall ID
D-0189-2020
Check your lot numberHow we source this data

Summary

Basic Reset recalled Basic Reset Nuovi Skin Toner starting Oct 18, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0189-2020 on Nov 13, 2019. Reason: Marketed without an Approved NDA/ANDA. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA

Product description

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

Lot numbers, UPCs & expiration codes

Lots: 28917A, 23918A, 21519A

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-0189-2020
Classification
Class II
Status
Terminated
Recall initiated
Oct 18, 2019
FDA report date
Nov 13, 2019
Quantity
1000 bottles
Recall type
FDA Mandated
Recalling firm
Basic Reset Inc.

Original FDA data

Every field from FDA enforcement report D-0189-2020, 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
Lots: 28917A, 23918A, 21519A
Postal code
37075-7316
Report date
Nov 13, 2019
Product type
Drugs
Recall number
D-0189-2020
Classification
Class II
Recalling firm
Basic Reset Inc.
Product quantity
1000 bottles
Termination date
Oct 27, 2021
Reason for recall
Marketed without an Approved NDA/ANDA
Voluntary / mandated
FDA Mandated
Product description
Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0189-2020, published Nov 13, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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