Dental Alliance Holdings LLC recalls CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral Bio
Recalled February 2, 2022 · FDA recall D-0453-2022 · Dental Alliance Holdings
Hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. · FDA Class III
Units
6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. 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
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
Manufacturer(s)
Dental Alliance Holdings LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →