Ortiga mas Ajo Rey Reforzado con Omega 3 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 Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle…

Recall number

D-1296-2022

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

Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586