Drug Enforcement D-0658-2024

LABELING: LABEL MIX-UP.

Status

Terminated

Classification

Class III

Report Date

September 18, 2024

Termination Date

August 5, 2025

Product Information

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
Product quantity
—
Reason for recall
LABELING: LABEL MIX-UP.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
120 direct customers, Nationwide US. No foreign, DOD/VA.

Location & Firm

Recalling firm
Elevate Oral Care
Address
342 Pike Rd Ste 23

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0658-2024
Event ID
95219
Recall initiation date
August 20, 2024
Center classification date
September 12, 2024
Code info
Lot #G073DC, Exp 3/31/2026
More code info
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