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Recall Observatory FDA recall evidence

Drug product

Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705.

D-1158-2022

May 24, 2022

Class II

Product summary

Firm
Walmart Inc
Event
Event 90359
Status
Completed
Classification
Class II
Quantity
1308 bottles total
Official record key
drug-enforcement:D-1158-2022

Official wording

Reason: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.

Code information: All product lots.

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.