August 2024 FDA Recall Drug by Elevate Oral Care
D-0658-2024 - LABELING

This Class III drug recall was voluntarily initiated by Elevate Oral Care on August 20, 2024 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0658-2024

Reason for Recall
LABELING: LABEL MIX-UP.
Initiated
08-20-2024
Reported
09-18-2024
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95219
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Elevate Oral Care
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
120 direct customers, Nationwide US. No foreign, DOD/VA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-05-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# G073DC, Exp 3/31/2026