FDA (Drugs) recall action 68218
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: Eugene FDA laboratory analyses determined they 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.
Eugene Oregon, Inc. is recalling Black Ant capsules because FDA testing found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.
Eugene Oregon, Inc. is recalling African Black Ant capsules because FDA laboratory analyses found undeclared sildenafil. The product was marketed without an approved NDA/ANDA.
Eugene Oregon, Inc. is recalling MOJO RISEN because FDA testing found undeclared sildenafil and the product was marketed without an approved NDA or ANDA.