FDA-Drug2022-02-02Class III
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
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
180 single tube of lot 272109 and 180 single tube count of lot 272110
Manufactured in
812 Water Ave Ne, Albany, OR, United States
Products
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2022Don't want to check this manually?
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