FDA-Drug2022-02-02Class III
CTx36 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 six 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
90 single tubes of 352110 and 315 single tubes of 352111
Manufactured in
812 Water Ave Ne, Albany, OR, United States
Products
CTx36 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 six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0457-2022Don't want to check this manually?
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