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D-0658-2024Class III

Elevate Oral Care

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Elevate Oral Care
Product type
Drug
Status
Terminated
Report date
2024-09-18
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Firm state
FL
Initiated by
Voluntary: Firm initiated
Reason for recall

LABELING: LABEL MIX-UP.

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

Code / lot info

Lot #G073DC, Exp 3/31/2026

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →