March 2022 FDA Recall Drug by Revive Personal Products Company
D-0751-2022 - Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC

This Class II drug recall was voluntarily initiated by Revive Personal Products Company on March 21, 2022 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 peppermint oil and sage oil and has the wrong upc. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0751-2022

Reason for Recall
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Initiated
03-21-2022
Reported
04-13-2022
Quantity
6156 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89873
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.
Terminated
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-25-2024
Product Description About Product Description
Full technical description of the product.
The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714.

Batch or Lot Expiration Information

Lot# : 3640A, Exp 12/22