Drug & medication recalls High risk

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

Recall date
October 20, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Botanical Be recalls Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales d…
Recall number
D-0224-2024
FDA classification
Class I
Brand / firm
Botanical Be
Sold / distributed
USA Nationwide

Why it was recalled

Marketed Without an Approved NDA/ANDA: products found 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 King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138

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