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FDAFDA · Food and drugs·Recall number D-0658-2024

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

Published September 18, 2024 · Recall initiated: August 20, 2024

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

LABELING: LABEL MIX-UP.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Elevate Oral Care
Distributor
120 direct customers, Nationwide US. No foreign, DOD/VA.
Lot
Lot #G073DC, Exp 3/31/2026
Risk classification
Class III
Area (FDA)
drug
Country
United States

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