September 2021 FDA Recall Drug by Revive Personal Products Company
D-0364-2022 - 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

This Class II drug recall was voluntarily initiated by Revive Personal Products Company on September 28, 2021 for the product Drug. The FDA reported the reason for recall as 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. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0364-2022

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
Initiated
09-28-2021
Reported
01-19-2022
Quantity
258 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89289
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Revive Personal Products Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot 2091A, exp 7/2023