Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported February 2, 2022
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Dental Alliance Holdings LLC recalled CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride … - a low-severity action.
CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride … was recalled by Dental Alliance Holdings LLC in February 2, 2022. Reason: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.. Check the official notice for the remedy. Verify recall #D-0455-2022 with the FDA Drug before acting.
The recall
Dental Alliance Holdings LLC issued this low-severity FDA Drug recall-Subpotent Drug: Product contains less Sodium Fluoride than listed on product label..
- Low
- severity level
- Class III
- classification
- February 2, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0455-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0455-2022) was formally reported on February 2, 2022, with the manufacturer initiating the action on December 3, 2021. It is classified under Low severity (Class III), with a current status of Terminated. Dental Alliance Holdings LLC is listed as the recalling firm, operating out of Albany, OR. Federal records list the affected scope as 180 single tube of lot 272109 and 180 single tube count of lot 272110.
The documented reason for this recall is: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Distribution data in the federal record shows the product reached: Distributed nationwide with the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
180 single tube of lot 272109 and 180 single tube count of lot 272110
Related Recalls
6
5 from same agency
Product description
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0455-2022 |
| Date reported | February 2, 2022 |
| Date initiated | December 3, 2021 |
| Recalling firm | Dental Alliance Holdings LLC |
| Firm location | Albany, OR |
| Affected scope | 180 single tube of lot 272109 and 180 single tube count of lot 272110 |
| Distribution | Distributed nationwide with the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0455-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.. Recalled by Dental Alliance Holdings LLC. Units affected: 180 single tube of lot 272109 and 180 single tube count of lot 272110.
Why was this product recalled? ▼
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 2, 2022. Severity: Low. Recall number: D-0455-2022.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide with the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0455-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 2, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.