April 08, 2013

Recall of ROCK-IT MAN, a Dietary Supplement Due to Undeclared Active Ingredient

The Missouri Department of Health and Senior Services received information regarding a nationwide recall of ROCK-It MAN Male Enhancement Capsules sold between October, 2012 and April, 2013. Analytical tests conducted by the Food and Drug Administration (FDA) concluded that the products contained hydroxythiohomosildenafil, an analogue of sildenafil. Sildenafil is the active pharmaceutical ingredient in a FDA approved drug that is used to treat erectile dysfunction (ED) making these products unapproved new drugs.

This undeclared active ingredient poses a threat to consumers because hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. Additionally, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing.

All codes of ROCK-It MAN Male Enhancement Capsules are included in this recall. The products are blue capsules individually packaged on a cardboard blister card (1 capsule per blister card) and blister double pack (2 capsules per blister card). The products were sold as wholesale in the US to distributors who further distributed it nationwide through internet sales and at retail.

The full recall can be found at www.fda.gov/Safety/Recalls/ucm347026.htm?source=govdelivery.