FDA recall D-0364-2022

Revive Personal Products Company · Class II · 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

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

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2021-09-28
Report date
2022-01-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0364-2022