FDA recall D-1284-2022

Product

Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-06-10

Report date

2022-07-20

Termination date

2024-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1284-2022