FDA recall D-0224-2024

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2023-10-20

Report date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0224-2024