Dental Alliance Holdings LLC recalls CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g
Recalled February 2, 2022 · FDA recall D-0459-2022 · Dental Alliance Holdings
Hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. · FDA Class III
Units
360 individual tubes of lot 142017.
Sold at
Distributed nationwide with the United States
Description
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
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.
Manufacturer(s)
Dental Alliance Holdings LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →