FDA Drug recall D-0046-2025
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured b…
- FDA Drug
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured b… by Keystone Industries, citing subpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0046-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-17 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Keystone Industries |
| Distribution | US |
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
Subpotent Drug
Identifiers
| code_info | Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0046-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.