Dental Alliance Holdings LLC recalls CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 6
Recalled February 2, 2022 · FDA recall D-0456-2022 · Dental Alliance Holdings
Hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. · FDA Class III
Units
225 single tube of lot 31217 and 99 single tube of 312108
Sold at
Distributed nationwide with the United States
Description
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Product
CTx26 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 two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Manufacturer(s)
Dental Alliance Holdings LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →