PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 18, 2024 Initiated: August 20, 2024 #D-0658-2024

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.

Details

Recalling Firm
Elevate Oral Care
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Location
West Palm Beach, FL

Frequently Asked Questions

What product 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. Recalled by Elevate Oral Care.
Why was this product recalled?
LABELING: LABEL MIX-UP.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 18, 2024. Severity: Low. Recall number: D-0658-2024.