Drug 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.
D-0751-2022
Product summary
- Event
- Event 89873
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6156 bottles
- Official record key
drug-enforcement:D-0751-2022
Official wording
Reason: 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
Code information: Lot #: 3640A, Exp 12/22
Distribution pattern: Nationwide USA
Derived failure modes
-
Labeling or packaging
Labeling; Label mix-up and Wrong