FDA-Drug2022-02-02Class III
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.
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
225 single tube of lot 31217 and 99 single tube of 312108
Manufactured in
812 Water Ave Ne, Albany, OR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0456-2022Don't want to check this manually?
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