FDA (Drugs) recall action 94366
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: Products contain undeclared sildenafil.
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.
To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.
Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.