Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufact...
FDA Recall #D-0658-2024 — Class III — August 20, 2024
Product Description
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.
Recalling Firm
Elevate Oral Care — West Palm Beach, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Code Information
Lot #G073DC, Exp 3/31/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated