FDA Drug Class III — Least Serious

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.

Hazard

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

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 CariFre
Brand
Dental Alliance Holdings LLC
UPC
Lot #: 192107 and lot 192108 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017)

Units Affected

3 single tubes of lot 192107 and 3 single tubes of 192108