🔍 RecallPedia

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 Distributed in 12-pk/cases

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 #: 142017 Exp. Date 06/22
  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:

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 Distributed in 12-pk/cases

Product Codes/Lot Numbers:

Lot #: 142017 Exp. Date 06/22

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0453-2022

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