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Recall Observatory FDA recall evidence

Drug product

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

D-1295-2022

May 26, 2022

Class I

Product summary

Firm
Amazon.com, Inc.
Event
Event 90627
Status
Terminated
Classification
Class I
Quantity
2,441 bottles
Official record key
drug-enforcement:D-1295-2022

Official wording

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

Code information: Lot #: LTARTKNGOMG30220, Exp. Diciembre 2025 (December 2025).

Distribution pattern: Nationwide within the U.S.A.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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