FDA-Drug2022-02-02Class III
CariFree sample boxes, contains one tube 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.
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
8 single tubes of lot 492106 and 50 single tubes of lot 492107
Manufactured in
812 Water Ave Ne, Albany, OR, United States
Products
CariFree sample boxes, contains one tube 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0458-2022Don't want to check this manually?
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