Dental Alliance Holdings LLC recalls CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral Bi…

Recall date

December 3, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0453-2022

FDA classification

Class III

Brand / firm

Dental Alliance Holdings LLC

Sold / distributed

Distributed nationwide with the United States

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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