Dental Alliance Holdings LLC recalls CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57…
- Recall date
- December 3, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0459-2022
- 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
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.
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