FDA Drug Class III — Least Serious

CTx26 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 two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Hazard

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

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Products

CTx26 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 two bottles of
Brand
Dental Alliance Holdings LLC
UPC
Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)

Units Affected

225 single tube of lot 31217 and 99 single tube of 312108

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