Dental Alliance Holdings LLC recalls CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC:
Recalled February 2, 2022 · FDA recall D-0455-2022 · Dental Alliance Holdings
Hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. · FDA Class III
Units
180 single tube of lot 272109 and 180 single tube count of lot 272110
Sold at
Distributed nationwide with the United States
Description
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Product
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Manufacturer(s)
Dental Alliance Holdings LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →