CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 o...
FDA Recall #D-0456-2022 — Class III — December 3, 2021
Product Description
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.
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recalling Firm
Dental Alliance Holdings LLC — Albany, OR
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
225 single tube of lot 31217 and 99 single tube of 312108
Distribution
Distributed nationwide with the United States
Code Information
Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated