FDA Drug recall D-0456-2022
CTx26 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 Manufac…
- FDA Drug
- Class III
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class III recall of CTx26 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 Manufac… by Dental Alliance Holdings, citing subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0456-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-12-03 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dental Alliance Holdings |
| Distribution | US |
Product
CTx26 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 two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Identifiers
| code_info | Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0456-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.