Drug 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
D-0658-2024
Product summary
- Event
- Event 95219
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0658-2024
Official wording
Reason: LABELING: LABEL MIX-UP.
Code information: Lot #G073DC, Exp 3/31/2026
Distribution pattern: 120 direct customers, Nationwide US. No foreign, DOD/VA.
Derived failure modes
-
Labeling or packaging
LABELING: LABEL MIX-UP