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FDADecember 3, 2021drug

CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

dental alliancedental

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle. — Recall Details · AllClear