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Recall Observatory FDA recall evidence

Drug product

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

D-0224-2024

October 20, 2023

Class I

Product summary

Firm
Botanical Be
Event
Event 93257
Status
Ongoing
Classification
Class I
Quantity
235 bottles
Official record key
drug-enforcement:D-0224-2024

Official wording

Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

Code information: Lot 35421, exp 12/19/2025

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.