Product: CTx7 Kit, contains one tube 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 one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
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