# FDA recall D-0046-2025

> **Keystone Industries** · Class II · drug recall initiated 2024-10-17.

## 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

- **Recall number:** D-0046-2025
- **Recalling firm:** Keystone Industries
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-10-17
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gibbstown, NJ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-0046-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0046-2025. Source: US FDA. Licensed CC0.

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