Products found to contain undeclared medicines
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| The United States: Consumer Concepts Issues a Voluntary Nationwide Recall of ROCK-IT MAN All Natural Male Supplement Products Marketed as Dietary Supplements to Support Male Sexual Performance Due to Undeclared Active Ingredient Hydroxythiohomosildenafil |
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The Food and Drug Administration (FDA) announced that 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 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 were sold as wholesale in the US to distributors who further distributed it nationwide through internet sales and at retail.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm347026.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been released by FDA and was posted on the website of Drug Office on 22 March 2013.
Ends/ Tuesday, April 09, 2013
Issued at HKT 12:00
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