Artri Ajo King Reforzado con Ortiga y Omega 3 tablets recalled over undeclared diclofenac

Recall date

May 26, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Amazon.com, Inc. recalls Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINAL…

Recall number

D-1295-2022

FDA classification

Class I

Brand / firm

Amazon.com, Inc.

Sold / distributed

Nationwide within the U.S.A.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Artri Ajo 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 B092P4615M, UPC 7 501031 111190