CTx7 Kit Recalled for Subpotent Sodium Fluoride Content
The FDA is recalling CTx7 Kits distributed nationwide because the product contains less sodium fluoride than stated on the label.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving subpotent drug content. The source text does not report any illnesses, injuries, or adverse events. The hazard is a labeling/content discrepancy rather than a toxic contamination, making this a moderate-severity recall appropriate for Class III classification.
Plain-English summary
Dental Alliance Holdings LLC is recalling CTx7 Kits that contain one tube of CariFree CTx4 Gel 5000 (1.1% Neutral Sodium Fluoride Mint, 2 oz) and one bottle of CariFree CTx3 Rinse (Mint Anticavity Rinse, 16 fl oz) due to subpotency. The product contains less sodium fluoride than listed on the product label.
The affected lots are 192107 and 192108, with an expiration date of 06/22. These lots contain the recalled CariFree CTx4 5000 gel tube lot 142017. The product was distributed nationwide within the United States.
Consumers who have purchased this product should stop using it and consult their healthcare provider if they have concerns about their fluoride intake or oral health.
The recalled product
- Product
- CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
- Manufacturer
- Dental Alliance Holdings LLC
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Dental Alliance Holdings LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Dental Alliance Holdings LLC
See all →- ModerateCariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall
FDA (Drugs) · 2022-02-02
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