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The United States: XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, due to Unlisted, Potentially Hazardous Ingredient
 
XROCK INDUSTRIES, is conducting a user level voluntary recall of certain supplement products under the brand name of X-ROCK. Finished product of X-ROCK for Men was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug. Analytical tests conducted by the Food and Drug Administration (FDA) of X-ROCK for Men concluded that the products contained sildenafil and hydroxythiohomosildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). Hydroxythiohomosildenafil is an analogue of sildenafil and is expected to possess a similar pharmacological and adverse event profile. These undeclared active ingredients pose a threat to consumers because sildenafil and 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 lot numbers of X-Rock for Men, within expiration, are included in this recall. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm301210.htm

In Hong Kong, the above product is not a registered pharmaceutical product. The news has been released by the FDA on 18 April 2012 and was posted on the website of Drug Office on 19 April 2012.


Ends/ Monday, April 23, 2012
Issued at HKT 11:22
 
Related Information:
Health Canada: Foreign Product Alert: Z-Rock All Natural Male Supplement,Extra P... Posted 2012-12-22
The United States: X-ROCK 3 Day Pill For Men and Z-ROCK: Recall – Undeclared Dru... Posted 2012-07-25
Canada: Removal of Potentially Dangerous Products, "X-Rock", "Kaboom" and "One F... Posted 2012-05-25
The United States: Public Notification: “X-Rock” Contains Undeclared Drug Ingred... Posted 2012-04-19
 
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