# FDA recall D-0658-2024

> **Elevate Oral Care** · Class III · drug recall initiated 2024-08-20.

## Product

Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

## Reason for recall

LABELING: LABEL MIX-UP.

## Distribution

120 direct customers, Nationwide US. No foreign, DOD/VA.

## Key facts

- **Recall number:** D-0658-2024
- **Recalling firm:** Elevate Oral Care
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-08-20
- **Report date:** 2024-09-18
- **Termination date:** 2025-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Palm Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2024

## Citation

> AI Analytics. FDA recall D-0658-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0658-2024. Source: US FDA. Licensed CC0.

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