FDA (Drugs) recall action 67860
The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
The agency’s own wording, quoted from the enforcement report.
Nova Products, Inc. is voluntarily recalling XZONE GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.
Nova Products, Inc. is voluntarily recalling XZone 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil.
Nova Products, Inc. is voluntarily recalling African Black Ant capsules because FDA testing found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.
Nova Products, Inc. is voluntarily recalling Black Ant capsules because FDA analysis found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.
Nova Products, Inc. is voluntarily recalling XZEN Platinum capsules because FDA analysis found undeclared sildenafil and tadalafil.
Nova Products, Inc. is voluntarily recalling XZEN GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.
Nova Products, Inc. is voluntarily recalling Mojo Risen because FDA testing found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.
Nova Products, Inc. is voluntarily recalling Xzen 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil, active ingredients in erectile dysfunction drugs.