CariFree CTx36 Kit recalled for subpotent fluoride content
Dental Alliance Holdings LLC is recalling the CTx36 Kit because it contains less sodium fluoride than stated on the product label. Affected patients should contact their dentist.
What this means for you
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 a labeling/potency discrepancy with no reported illnesses or injuries. Class III recalls are typically scored 1–2; a potency deficiency in a topical dental product without documented harm warrants a Moderate (2) rating as a precautionary measure for a prescription medication.
Plain-English summary
Dental Alliance Holdings LLC is recalling the CTx36 Kit, which contains three tubes of CariFree CTx4 Gel 5000 (1.1% Neutral Sodium Fluoride Mint, 2 oz each) and six boxes of 4 fl.oz. CariFree CTx4 Treatment Rinse. The product is an Rx-only dental fluoride treatment.
The recall was initiated because the product contains less sodium fluoride than listed on the product label, making it subpotent. The affected product includes lot numbers 352110 and 352111 with an expiration date of 06/22. The recalled CTx36 Kit contains CariFree CTx4 5000 gel tube lot 142017.
The product was distributed nationwide throughout the United States. Patients who have received or been prescribed this product should contact their dentist or healthcare provider for guidance on whether they need re-treatment or additional care.
The recalled product
- Product
- CTx36 Kit, contains three tubes of 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 six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
- Manufacturer
- Dental Alliance Holdings LLC
- Category
- Drug — Fluoride dental treatment
- Hazard
- subpotent-active-ingredient
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 352110
- 352111 Exp. Date 06/22
- (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Distribution
Distributed nationwide across the United States.
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