FDA (Drugs) recall action 63232
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 an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
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.
Evol Nutrition is recalling Mojo Nights for Her capsules because they contain unapproved ingredients used to treat male erectile dysfunction.
Evol Nutrition is recalling Mojo Nights capsules because they contain unapproved ingredients used to treat erectile dysfunction.