FDAFDA · Food and drugs·Recall number D-0456-2022
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.
Published February 2, 2022 · Recall initiated: December 3, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dental Alliance Holdings LLC
- Distributor
- Distributed nationwide with the United States
- Lot
- Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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