activator concentrate — Class II drug recall D-1100-2023
Completed recall by Ecometics, Inc., reported 2023-08-30, distributed nationwide. CGMP Deviations: Products not manufactured under current good manufacturing practices.
| Recall number | D-1100-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecometics, Inc., Norwalk, CT, United States |
| Recall initiated | 2023-08-09 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 32,583 bottles |
| Reason classes | cgmp |
| Lot numbers | 1E175B, 6/24 |
Product
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
Reason for recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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-1100-2023. 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.