Drug recall
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for…
FDA recall event 95219 · Class III · Elevate Oral Care
Key facts
| Event ID | 95219 |
|---|---|
| Recall numbers | D-0658-2024 |
| Recalling firm | Elevate Oral Care |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | LABELING: LABEL MIX-UP. |
| Initiation date | Aug 20, 2024 |
| Report date | Sep 18, 2024 |
| Termination date | Aug 5, 2025 |
| City | West Palm Beach |
| State | FL |
| Country | United States |
| FEI number | 3009603151 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: