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

Class I - Dangerous
💊 Drugs Recalled: October 17, 2024 Keystone Industries Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Keystone Industries
Reason for Recall:
Subpotent Drug
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0046-2025

Related Recalls

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Nov 14, 2024 Other Drugs Nationwide View Details →

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Nov 14, 2024 Other Drugs Nationwide View Details →

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Nov 14, 2024 Other Drugs Nationwide View Details →