Consumer Concepts is recalling all 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. Hydroxythiohomosildenafil is an analogue of sildenafil and is close in structure to 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 (ED) making these products unapproved new drugs.

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This undeclared active ingredient poses a threat to consumers because it 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. Hydroxythiohomosildenafil, like sildenafil, may cause side effects such as headaches and flushing.

Consumer Concepts says it has not received any reports of adverse events related to 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). They were sold as wholesale in the US to distributors who further distributed them nationwide through internet sales and at retail.

The ROCK-It MAN male enhancement capsules back panel reads "Distributed by Consumer Concepts".

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.

Consumers should return any unused products for a refund of the full purchase price to the retailer from which it was purchased.

Customers can call 310-228-8965 Monday – Friday between the hours of 9am-4pm Central Time for more information.

Source: www.consumeraffairs.com