FDA-Drug2022-02-02Class III
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
Dental Alliance Holdings LLC
Hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Sold states
Distributed nationwide with the United States
Affected count
6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017
Manufactured in
812 Water Ave Ne, Albany, OR, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2022Don't want to check this manually?
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