Drug 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
D-0046-2025
Product summary
- Event
- Event 95647
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 787 pumps
- Official record key
drug-enforcement:D-0046-2025
Official wording
Reason: Subpotent Drug
Code information: Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent