Drug product
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
D-0492-2025
Product summary
- Firm
- Umary-USA.com
- Event
- Event 96914
- Status
- Completed
- Classification
- Class I
- Quantity
- 1,342 30-count bottles
- Official record key
drug-enforcement:D-0492-2025
Official wording
Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Code information: All Lots; All Expiration Dates.
Distribution pattern: U.S. Nationwide via internet.
Derived failure modes
-
Unknown
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.