Makers of a supplement marketed as a male sexual enhancement product issued a voluntary recall of the product after an FDA analysis found undeclared traces of sulfoaildenafil, an analog to the erectile dysfunction drug sildenafil. The supplement Prolatis is considered an unapproved drug because of the unlisted ingredient. Like its analog, sulfoaildenafil may cause an unsafe drop in blood pressure in patients taking nitrates. Here are the details from MedPage Today:
The product was sold in double blister packs and 40-count bottles. All products manufactured before Aug. 9, 2010 are included in the recall.
The manufacturer of Prolatis has not received any adverse event reports related to the product recall, the company said in a prepared statement. The company asked consumers to return the product for a full credit toward a new item.