FDA recall D-1297-2022

Product

Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190

Reason for recall

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

Distribution

Nationwide within the U.S.A.

Key facts

Status

Terminated

Initiation date

2022-05-26

Report date

2022-07-27

Termination date

2022-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seattle, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1297-2022