FDA Drug recall D-0459-2022
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 6157…
- FDA Drug
- Class III
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class III recall of CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 6157… 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-0459-2022 |
| 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
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Reason
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Identifiers
| code_info | Lot #: 142017, exp. Date 06/22 |
|---|
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-0459-2022%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.