Recalls / Class II

Class IID-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

Affected lot / code info

Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026

Why it was recalled

Subpotent Drug

Recalling firm

Firm

Keystone Industries

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

480 S Democrat Rd, N/A, Gibbstown, New Jersey 08027-1239

Distribution

Quantity

787 pumps

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2024-10-17

FDA classified

2024-11-14

Posted by FDA

2024-11-20

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0046-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.