# FDA recall D-0451-2023

> **Ecometics, Inc.** · Class II · drug recall initiated 2023-02-24.

## 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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0451-2023
- **Recalling firm:** Ecometics, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-24
- **Report date:** 2023-03-15
- **Termination date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwalk, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2023

## Citation

> AI Analytics. FDA recall D-0451-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0451-2023. Source: US FDA. Licensed CC0.

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