Why it was recalled
Subpotent Drug
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0046-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 17, 2024
- FDA report date
- Nov 20, 2024
- Quantity
- 787 pumps
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Keystone Industries
Original FDA data
Every field from FDA enforcement report D-0046-2025, exactly as published.
Show all FDA fields
- City
- Gibbstown
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95647
- Address
- 480 S Democrat Rd
- Code information
- Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
- Postal code
- 08027-1239
- Report date
- Nov 20, 2024
- Product type
- Drugs
- Recall number
- D-0046-2025
- Classification
- Class II
- Recalling firm
- Keystone Industries
- Product quantity
- 787 pumps
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2024