FDA (Drugs) recall action 96914
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
The agency’s own wording, quoted from the enforcement report.
UMOVY ACIDO HIALURONICO dietary supplement has been recalled because it contains undeclared prescription ingredients Dexamethasone and Diclofenac. The product was marketed without FDA approval.
UNAVY ACIDO HIALURONICO hyaluronic acid supplement is being recalled because it contains three undeclared pharmaceutical ingredients: Dexamethasone, Diclofenac, and Omeprazole. The product was marketed without FDA approval and poses health risks from the unlisted drugs.