D-0658-2024 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2024
- Initiation Date
- August 20, 2024
- Termination Date
- August 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
120 direct customers, Nationwide US. No foreign, DOD/VA.
Code Information
Lot #G073DC, Exp 3/31/2026