Why it was recalled
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
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 3640A, Exp 12/22
Where it was sold
Nationwide USA
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-0751-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 6156 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Revive Personal Products Company
Original FDA data
Every field from FDA enforcement report D-0751-2022, exactly as published.
Show all FDA fields
- City
- Allendale
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89873
- Address
- 2 Myrtle Ave
- Code information
- Lot #: 3640A, Exp 12/22
- Postal code
- 07401-1515
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0751-2022
- Classification
- Class II
- Recalling firm
- Revive Personal Products Company
- Product quantity
- 6156 bottles
- Termination date
- Jul 25, 2024
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Mar 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2022