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D-0658-2024 Class III Terminated

Recalled by Elevate Oral Care — West Palm Beach, FL

FDA drug recall D-0658-2024 was initiated by Elevate Oral Care on August 20, 2024 and is designated Class III. Reason for recall: LABELING: LABEL MIX-UP. The recall status is terminated (terminated August 5, 2025).

Recall Details

Product Type: Drugs
Report Date: September 18, 2024
Initiation Date: August 20, 2024
Termination Date: August 5, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

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.

Distribution Pattern

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

Code Information

Lot #G073DC, Exp 3/31/2026