Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral C
Summary
The FDA issued a Class III for Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), by Elevate Oral Care. Reason: LABELING: LABEL MIX-UP..
Details
Source
Drug Recall
External ID
D-0658-2024
Action Date
2024-09-18
Status
Terminated
Category
drug
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/Code Info: Lot #G073DC, Exp 3/31/2026
Reason for Recall
LABELING: LABEL MIX-UP.
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-20
Company
West Palm Beach, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 24 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Elevate Oral Care has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elevate Oral Care) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elevate Oral Care have FDA actions?
Elevate Oral Care has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0658-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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