Dental Alliance recalls CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint due to containing less sodium fluoride than labeled. This subpotent drug may not provide adequate cavity prevention. Product sold in 12-packs with specific lot numbers.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance is recalling CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint because it contains less sodium fluoride than labeled. This means the product may not prevent cavities as intended, especially for people needing fluoride treatment.
The product contains less sodium fluoride than stated on the label. This subpotent concentration may not provide sufficient cavity prevention for users who need the full strength of fluoride. The risk is primarily for people with existing tooth decay or those at high risk for cavities.
People with dental insurance who use prescription fluoride mouthwash. Those at highest risk are individuals with cavities or a history of tooth decay who rely on this product for cavity prevention.
Check for the product name 'CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint', 2 oz (57 g) size, and NDC code 61578-205-01. It was distributed in 12-packs with lot numbers starting with 142017 and expires June 22, 2022.
Look for the NDC code 61578-205-01 on the product label to confirm it's the recalled item.
The product may not provide adequate cavity prevention due to lower sodium fluoride content than labeled. It is not recommended for people who need full-strength fluoride treatment.
The recall does not specify a remedy, so check with your dentist or pharmacist for advice on alternatives.
Look for the product name 'CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint', 2 oz size, NDC 61578-205-01, and lot numbers starting with 142017.
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-0453-2022 — Dental Alliance Holdings Dental Alliance Holdings Hello, I own a Dental Alliance Holdings that is covered by recall D-0453-2022 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.
