ISSUE: Consumer Concepts, Inc. notified the public of a consumer/user level recall of all ROCK-It MAN Male Enhancement Capsules sold between October, 2012 and April, 2013. Analytical tests conducted by the FDA concluded that the product contained hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in a FDA approved drug that is used to treat erectile dysfunction, making these products unapproved new drugs.
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. ED is a common problem in men with these conditions and they may seek products to enhance sexual performance. 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.
BACKGROUND: 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.
RECOMMENDATION: Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking this product.
The Company is advising consumers to return any unused products to the retail location from which it was purchased. Customers can call 310-228-8965 Monday – Friday between the hours of 9am-4pm Central Time for directions on returning the product.
[04/01/2013 - Press Release - Consumer Concepts, Inc]