CariFree CTx4 Gel 5000 Sample Boxes Recalled for Subpotent Fluoride
CariFree sample boxes containing CTx4 Gel 5000 are being recalled because the product contains less Sodium Fluoride than stated on the label. Affected lots are 492106 and 492107, distributed nationwide.
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: The FDA classified this recall as Class III. The hazard is a labeling discrepancy (subpotency) with no reported illnesses or injuries, making this a moderate-severity precautionary recall involving a labeling/potency issue.
Plain-English summary
Dental Alliance Holdings LLC is recalling CariFree sample boxes that contain one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint (2 oz / 57 g). The affected product is available by prescription only (NDC: 61578-205-01) and was manufactured by Oral BioTech in Albany, Oregon.
The recall was initiated because the product contains less Sodium Fluoride than listed on the product label. This affects 8 single tubes from lot 492106 and 50 single tubes from lot 492107, both with an expiration date of June 2022.
The recalled product has been distributed nationwide within the United States. Consumers who have received these sample boxes should consult their healthcare provider or dentist about whether their medication needs adjustment.
The recalled product
- Product
- CariFree sample boxes, contains one tube 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.
- Manufacturer
- Dental Alliance Holdings LLC
- Category
- Drug — Topical Fluoride Gel
- Hazard
- subpotent-drug
- labeling-error
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 (1)
- Lot #: 492106
Distribution
Distributed nationwide across the United States.
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