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Recall D-0658-2024

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

Recall D-0658-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0658-2024
Event ID95219
Distribution120 direct customers, Nationwide US. No foreign, DOD/VA.
Recall ReasonLABELING: LABEL MIX-UP.
Drug ClassificationClass III
Drug Code Info20240918
Recall Initiation Date20240820
Report Date20240918
Classification Date20240912
Address342 Pike Rd Ste 23
West Palm Beach, FL 33411-3820
United States
Recalling FirmElevate Oral Care
Initial Notification Letter
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