Elevate Oral Care recalls Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral…

Recall date

August 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0658-2024

FDA classification

Class III

Brand / firm

Elevate Oral Care

Sold / distributed

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

Why it was recalled

LABELING: LABEL MIX-UP.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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