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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Perio Maintenance Stannous Fluoride Rinse Recalled for Subpotency

Agency Publication Date: November 14, 2024
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Summary

Keystone Industries has voluntarily recalled 787 pumps of its Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution because the product is subpotent. This means the medication may contain less of the active ingredient than required, which could reduce its effectiveness. The recall affects the 10 oz. (283.5 g) Mint-flavored pumps, which were distributed nationwide in the United States.

Risk

A subpotent dental rinse may not provide the full therapeutic benefit intended, potentially leading to less effective prevention or treatment of dental plaque and gingivitis. No specific injuries or medical incidents have been reported in the current recall data.

What You Should Do

  1. This recall affects Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution (Mint flavor) sold in 10 oz. pumps with NDC 68400-202-10.
  2. Check the lot information on your pump's label for lot numbers PVC-003015 (Exp Sep-21-2025) or PVC-003061 (Exp Apr-30-2026).
  3. If you have health concerns about using this product, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Keystone Industries for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution (10 oz.)
Variants: Mint flavor, Rx Only
Lot Numbers:
PVC-003015 (Exp Sep-21-2025)
PVC-003061 (Exp Apr-30-2026)
NDC:
68400-202-10

Manufactured by Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95647
Status: Active
Manufacturer: Keystone Industries
Sold By: Pharmacies; Dental clinics; Authorized distributors
Manufactured In: United States
Units Affected: 787 pumps
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.