FDAHealthAugust 20, 2024
Elevate Oral Care — 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
⚠️ LABELING: LABEL MIX-UP.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 20, 2024
120 direct customers, Nationwide US. No foreign, DOD/VA.
What's affected?
- 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
- Brand
- Elevate Oral Care
- Lot code
- G073DC
Additional details
Lot #G073DC, Exp 3/31/2026
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated
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