CTx21 Kit — Class III drug recall D-0455-2022
Terminated recall by Dental Alliance Holdings LLC, reported 2022-02-02, distributed nationwide. Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
| Recall number | D-0455-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dental Alliance Holdings LLC, Albany, OR, United States |
| Recall initiated | 2021-12-03 |
| Classified | 2022-01-26 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2022-08-11 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 61578-0205-01 |
| Lot numbers | 06/22, 142017, 272109, 272110 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0455-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.