FDAClass IIIFebruary 2, 2022

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 recall: Subpotent

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01…

Why was CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 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
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01…
Recalling firm
Dental Alliance Holdings LLC
Quantity
360 individual tubes 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