FDA-Drug2022-02-02Class III
CTx7 Kit, contains one tube 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 one bottle 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
3 single tubes of lot 192107 and 3 single tubes of 192108
Manufactured in
812 Water Ave Ne, Albany, OR, United States
Products
CTx7 Kit, contains one tube 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 one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0454-2022Don't want to check this manually?
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