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Recall Observatory FDA recall evidence

Drug product

Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.

D-1157-2022

May 24, 2022

Class I

Product summary

Firm
Walmart Inc
Event
Event 90359
Status
Completed
Classification
Class I
Quantity
1308 bottles total
Official record key
drug-enforcement:D-1157-2022

Official wording

Reason: Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.

Code information: Lot: LTARTKNGOMG30720, Exp Diciembre 2026

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.