Drug recall D-0658-2024

Class III Terminated reported Sep 18, 2024

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.

Lots and codes

Lot #G073DC, Exp 3/31/2026

Recall details

Recalling firm
Elevate Oral Care, West Palm Beach, FL
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Type
Voluntary: Firm initiated
Recall initiated
August 20, 2024
Terminated
August 5, 2025