Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #G073DC, Exp 3/31/2026
Where it was sold
120 direct customers, Nationwide US. No foreign, DOD/VA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0658-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 20, 2024
- FDA report date
- Sep 18, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Elevate Oral Care
Original FDA data
Every field from FDA enforcement report D-0658-2024, exactly as published.
Show all FDA fields
- City
- West Palm Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 95219
- Address
- 342 Pike Rd Ste 23
- Code information
- Lot #G073DC, Exp 3/31/2026
- Postal code
- 33411-3820
- Report date
- Sep 18, 2024
- Product type
- Drugs
- Recall number
- D-0658-2024
- Classification
- Class III
- Recalling firm
- Elevate Oral Care
- Termination date
- Aug 5, 2025
- Reason for recall
- LABELING: LABEL MIX-UP.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Aug 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2024