Dental Alliance Holdings recalls CTx12 5000 Kit (3 boxes of CariFree CTx4 GEl 5000 gel tubes) due to less sodium fluoride than labeled. This may reduce effectiveness for cavity prevention.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance Holdings recalls CTx12 5000 Kit, which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. The product contains less sodium fluoride than listed on the label, potentially reducing its effectiveness for cavity prevention.
The product contains less sodium fluoride than stated on the label. This means it may not provide the intended cavity prevention benefits as advertised, but it does not pose a risk of injury or harm.
People who own or use the CTx12 5000 Kit for dental care. Those with specific dental needs may be at slightly higher risk due to reduced effectiveness.
Check for the CTx12 5000 Kit with 3 boxes of CariFree CTx4 GEl 5000 gel tubes. The product label lists 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) and is a prescription-only item (NDC: 61578-205-01).
Look for the product label that lists 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) and NDC: 61578-205-01.
No, the product is not dangerous but may be less effective than labeled due to lower sodium fluoride content.
Check for the CTx12 5000 Kit with 3 boxes of CariFree CTx4 GEl 5000 gel tubes, labeled with 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g), and NDC: 61578-205-01.
The recall does not require immediate action, but you may want to contact Dental Alliance Holdings for further guidance.
We’ve drafted a message you can send Dental Alliance Holdings to request your refund or repair — edit it as you like.
Subject: Recall D-0459-2022 — Dental Alliance Holdings Dental Alliance Holdings Hello, I own a Dental Alliance Holdings that is covered by recall D-0459-2022 from Dental Alliance Holdings. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
