Drug Enforcement D-0493-2025

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

Status

Ongoing

Classification

Class I

Report Date

June 25, 2025

Termination Date

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Product Information

Product description
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Product quantity
1,704 30-count bottles
Reason for recall
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
U.S. Nationwide via internet.

Location & Firm

Recalling firm
Umary-USA.com
Address
243 W Crawford St, STE 40026

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0493-2025
Event ID
96914
Recall initiation date
May 21, 2025
Center classification date
June 24, 2025
Code info
All Lots; All Expiration Dates.
More code info
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