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 Distributed in 12-pk/cases

Recall Number: D-0453-2022

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.

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 Distributed in 12-pk/cases