FDA (Drugs) recall action 72830
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: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), 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.
Reesna, Inc. is recalling Fuel Up Plus capsules marketed as a dietary supplement because they contain undeclared hydroxythiohomosildenafil, an analogue of the ED drug sildenafil.
Reesna, Inc. is recalling Fuel Up High Octane capsules because they contain undeclared hydroxythiohomosildenafil, an analogue of the prescription drug Sildenafil.