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CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fl...

FDA Recall #D-0459-2022 — Class III — December 3, 2021

Recall #D-0459-2022 Date: December 3, 2021 Classification: Class III Status: Terminated

Product Description

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 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

360 individual tubes 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

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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