Dental Alliance Holdings recalls CTx36 Kit (NDC 61578-205-01) due to less sodium fluoride than labeled. This subpotent drug may not provide intended dental protection. Consumers should contact the manufacturer for details.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance Holdings is recalling CTx36 Kit products because they contain less sodium fluoride than stated on the label. This means the gel may not effectively prevent tooth decay as intended. Affected consumers should stop using the product and contact the manufacturer.
The product contains less sodium fluoride than listed on the label, which means it may not provide the intended dental protection. This subpotent drug could lead to reduced effectiveness in preventing tooth decay. However, the risk is not severe enough to cause serious injury.
People who own or use the CTx36 Kit for dental care are affected. Those with specific dental needs may be at higher risk if the product doesn't provide adequate protection.
Check for the CTx36 Kit with three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g). The product was manufactured by Oral BioTech in Albany, Oregon and sold with lot numbers 352110 or 352111, expiring June 2022.
Discard the CTx36 Kit immediately as it contains less sodium fluoride than labeled.
The product contains less sodium fluoride than listed on the label, which may reduce its effectiveness in preventing tooth decay.
Discard the CTx36 Kit immediately and contact Dental Alliance Holdings for further instructions.
No, the recall is for a subpotent drug that may not provide intended dental protection, not a risk of serious injury.
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-0457-2022 — Dental Alliance Holdings Dental Alliance Holdings Hello, I own a Dental Alliance Holdings that is covered by recall D-0457-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
