Recall Enforment Report D-0492-2025
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Umary-USA.com, originally initiated on 05-21-2025 for the 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 The product was recalled due to marketed without approved nda/anda- laboratory analysis found product to be tainted with undeclared ingredients: dexamethasone, diclofenac and omeprazole.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0492-2025 | 05-21-2025 | 06-25-2025 | Class I | 1,342 30-count bottles | 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 | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. | Ongoing |
D-0493-2025 | 05-21-2025 | 06-25-2025 | Class I | 1,704 30-count bottles | UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134 | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. | Ongoing |