CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

Recall Number: D-0455-2022

Firm: Dental Alliance Holdings LLC

Classification: Class III

Status: Terminated

Report Date: 20220202

Initiation Date: 20211203

Termination Date: 20220811

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.