FDA recall D-0046-2025

Product

Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10

Reason for recall

Subpotent Drug

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-10-17

Report date

2024-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gibbstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0046-2025