Drug & medication recalls High risk

Arti King Refozado con Ortiga y Omega 3 Tablets recalled over undeclared diclofenac

Recall date
June 10, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Latin Foods Market recalls Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO…
Recall number
D-1284-2022
FDA classification
Class I
Brand / firm
Latin Foods Market
Sold / distributed
Nationwide in the USA

Why it was recalled

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

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

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

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