Product: CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
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