Dental Alliance Holdings recalls CTx7 Kit (NDC 61578-2:205-01) due to less sodium fluoride than labeled. This subpotent drug may not provide adequate cavity prevention. Consumers should contact the manufacturer for details.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance Holdings is recalling CTx7 Kits that contain CariFree CTx4 Gel 5000 with less sodium fluoride than labeled. This could mean the product doesn't prevent cavities as intended, so users should check if they have the recalled kit.
The product contains less sodium fluoride than listed on the label. This means it may not prevent cavities as effectively as intended. The issue is a labeling discrepancy, not a safety hazard.
People who have the CTx7 Kit with the specific lot numbers (192107 or 192108) and expiration date 06/22. Those using the product for cavity prevention are most at risk.
Check for the CTx7 Kit with NDC 61578-205-01, lot numbers 192107 or 192108, and expiration date 06/22. The kit includes one tube of CariFree CTx4 Gel 5000 and one bottle of CariFree CTx3 Rinse.
Look for the NDC code 61578-205-01, lot numbers 192107 or 192108, and expiration date 06/22 on the CTx7 Kit.
The product may not prevent cavities as intended due to less sodium fluoride than labeled, but it is not a safety hazard.
Contact Dental Alliance Holdings for details on the remedy. The recall record does not specify a remedy.
Check for the NDC code 61578-205-01, lot numbers 192107 or 192108, and expiration date 06/22 on the CTx7 Kit.
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-0454-2022 — Dental Alliance Holdings Dental Alliance Holdings Hello, I own a Dental Alliance Holdings that is covered by recall D-0454-2022 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.
