🔍 RecallPedia

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Class I - Dangerous
💊 Drugs Recalled: December 3, 2021 Dental Alliance Holdings Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
  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:
Dental Alliance Holdings LLC
Reason for Recall:
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Product Codes/Lot Numbers:

Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0456-2022

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