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
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Classification
Class III
Status
Terminated
Lot
Lot #: 192107 and lot 192108 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.