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Class II: temporary or reversible health riskOngoing

Revive Personal Products The Natural Dentist Healthy Balance Recall

The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0

Revive Personal Products Company · Allendale, NJ

Risk level
Class II
Reported by FDA
Jan 19, 2022
Recall ID
D-0364-2022
Check your lot numberHow we source this data

Summary

Revive Personal Products recalled The Natural Dentist Healthy Balance starting Sep 28, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0364-2022 on Jan 19, 2022. Reason: Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8. Status: Ongoing.

Why it was recalled

Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8

Product description

The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4

Lot numbers, UPCs & expiration codes

Lot 2091A, exp 7/2023

Where it was sold

Nationwide

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-0364-2022
Classification
Class II
Status
Ongoing
Recall initiated
Sep 28, 2021
FDA report date
Jan 19, 2022
Quantity
258 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Revive Personal Products Company

Original FDA data

Every field from FDA enforcement report D-0364-2022, exactly as published.

Show all FDA fields
City
Allendale
State
NJ
Status
Ongoing
Country
United States
Event ID
89289
Address
2 Myrtle Ave
Code information
Lot 2091A, exp 7/2023
Postal code
07401-1515
Report date
Jan 19, 2022
Product type
Drugs
Recall number
D-0364-2022
Classification
Class II
Recalling firm
Revive Personal Products Company
Product quantity
258 bottles
Reason for recall
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Voluntary / mandated
Voluntary: Firm initiated
Product description
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Distribution pattern
Nationwide
Recall initiation date
Sep 28, 2021
Initial firm notification
Letter
Center classification date
Jan 10, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0364-2022, published Jan 19, 2022. 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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