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Recall Observatory FDA recall evidence

Drug product

UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134

D-0493-2025

May 21, 2025

Class I

Product summary

Firm
Umary-USA.com
Event
Event 96914
Status
Completed
Classification
Class I
Quantity
1,704 30-count bottles
Official record key
drug-enforcement:D-0493-2025

Official wording

Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.

Code information: All Lots; All Expiration Dates.

Distribution pattern: U.S. Nationwide via internet.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.