Activator Concentrate — Class II drug recall D-0451-2023
Terminated recall by Ecometics, Inc., reported 2023-03-15, distributed nationwide. CGMP DEVIATIONS
| Recall number | D-0451-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecometics, Inc., Norwalk, CT, United States |
| Recall initiated | 2023-02-24 |
| Classified | 2023-03-08 |
| Reported by FDA | 2023-03-15 |
| Terminated | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 34,320 bottles |
| Reason classes | cgmp |
| Lot numbers | 2E055A, FEB-2025 |
Product
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
Reason for recall
CGMP DEVIATIONS
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-0451-2023. 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.