CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 M...
FDA Recall #D-0453-2022 — Class III — December 3, 2021
Product Description
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 Distributed in 12-pk/cases
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
6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017
Distribution
Distributed nationwide with the United States
Code Information
Lot #: 142017 Exp. Date 06/22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated