FDAClass IIIFebruary 2, 2022

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride recall: Subpotent

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…

Why was CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 142017 Exp. Date 06/22

Product
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…
Recalling firm
Dental Alliance Holdings LLC
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
Recall date
February 2, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls