FDAnews Drug Daily Bulletin

Firm Recalls Supplements Containing Undeclared ED Drug

July 10, 2008

Jack Distribution is voluntarily recalling certain lots of its Rize 2 The Occasion capsules and Rose 4 Her capsules because they contain an undeclared ingredient similar to the active ingredient of an erectile dysfunction (ED) drug.

An FDA analysis found some lots of the dietary supplements, manufactured and packaged in 2007, contained thiomethisosildenafil, an analog of sildenafil, the active ingredient in Pfizer’s Viagra. This chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, the FDA said.

Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, the agency added. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Jack Distribution said it is working closely with the FDA in the recall process and is committed to the quality and integrity of its products.