Product: 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.
Reason for recall: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall initiated: 20211203
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated