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CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 o...

FDA Recall #D-0457-2022 — Class III — December 3, 2021

Recall #D-0457-2022 Date: December 3, 2021 Classification: Class III Status: Terminated

Product Description

CTx36 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 six 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

90 single tubes of 352110 and 315 single tubes of 352111

Distribution

Distributed nationwide with the United States

Code Information

Lot #: 352110, 352111 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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