Drug 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
D-0364-2022
Product summary
- Event
- Event 89289
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 258 bottles
- Official record key
drug-enforcement:D-0364-2022
Official wording
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
Code information: Lot 2091A, exp 7/2023
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label mix-up and Wrong