CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride ...
FDA Recall #D-0458-2022 — Class III — December 3, 2021
Product Description
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.
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
8 single tubes of lot 492106 and 50 single tubes of lot 492107
Distribution
Distributed nationwide with the United States
Code Information
Lot #: 492106, 492107 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated