FDA (Drugs) recall action 66406
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Haute Health is recalling Virilis Pro dietary supplements because they may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.
Haute Health, LLC is recalling PHUK Sexual Enhancement Ultimate Pleasure because it may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.
Haute Health, LLC is recalling Prolifta dietary supplements because they may contain unapproved active ingredients used in erectile dysfunction drugs.