UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C....
FDA Recall #D-0493-2025 — Class I — May 21, 2025
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
Reason for Recall
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Recalling Firm
Umary-USA.com — Nogales, AZ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1,704 30-count bottles
Distribution
U.S. Nationwide via internet.
Code Information
All Lots; All Expiration Dates.
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated