Drug Enforcement D-0224-2024

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

Status

Ongoing

Classification

Class I

Report Date

December 6, 2023

Termination Date

—

Product Information

Product description
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
Product quantity
235 bottles
Reason for recall
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Botanical Be
Address
360 Jardin Bello

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

Codes & Dates

Recall number
D-0224-2024
Event ID
93257
Recall initiation date
October 20, 2023
Center classification date
January 12, 2024
Code info
Lot 35421, exp 12/19/2025
More code info
—