Elevate Oral Care: Drug Recall
Recall #D-0658-2024 · 08/20/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0658-2024
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Elevate Oral Care
- Status
- Terminated
- Date Initiated
- 08/20/2024
- Location
- West Palm Beach, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
LABELING: LABEL MIX-UP.
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
Distribution Pattern
120 direct customers, Nationwide US. No foreign, DOD/VA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.