FDA recall D-0658-2024

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2024-08-20

Report date

2024-09-18

Termination date

2025-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Palm Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2024