CLASS III Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report
CTx21 Kit, contains three tubes of CariFree CTx4 Gel recalled
Dental Alliance Holdings is recalling CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride, distributed nationwide in the US. The recall was initiated on 3 Dec 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0455-2022
- FDA event ID
- 89152
- Recalling firm
- Dental Alliance Holdings, Albany, OR
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Dec 2021
- FDA classified
- 26 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 3 Dec 2021 | Recall initiated by company | |
| 26 Jan 2022 | Classified by FDA | +54 days |
| 2 Feb 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Distributed nationwide with the United States
Questions about this recall
Why was it recalled?
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Which lots are affected?
Lot #: 272109, 272110 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Where was it sold?
Distributed nationwide with the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 89152This product is part of a recall event; the main page for the event is CTx7 Kit, contains one tube CariFree CTx4 Gel recalled.
More recalls from Dental Alliance Holdings
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | CTx26 Kit, contains three tubes of CariFree CTx4 Gel recalled | Dental Alliance Holdings | Potency & Assay | Nationwide |
| Drug | CLASS III | CTx36 Kit, contains three tubes of CariFree CTx4 Gel recalled | Dental Alliance Holdings | Potency & Assay | Nationwide |
| Drug | CLASS III | CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint recalled | Dental Alliance Holdings | Potency & Assay | Nationwide |
| Drug | CLASS III | CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl recalled | Dental Alliance Holdings | Potency & Assay | Nationwide |
| Drug | CLASS III | CariFree sample, contains one tube of CariFree CTx4 Gel recalled | Dental Alliance Holdings | Potency & Assay | Nationwide |