FDA Drug Class III — Least Serious

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.

Hazard

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

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
Brand
Dental Alliance Holdings LLC
UPC
Lot #: 272109, 272110 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)

Units Affected

180 single tube of lot 272109 and 180 single tube count of lot 272110