Rock-It Man male sexual performance drug recalled

Consumer Concepts Inc. is conducting a consumer/user level recall of all Rock-It Man Male Enhancement Capsules sold between October 2012 and April 2013.

Finished product of Rock-It Man Male Enhancement Capsules was tested and found to contain an analogue of an ingredient in an FDA-approved drug.

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.

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.

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.

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. 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 Rock-It Man Male Enhancement Capsules back panel reads "Distributed by Consumer Concepts."

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Rock-It Man male sexual performance drug recalled