Products found to contain undeclared medicines
|
| |
| The United States: X-ROCK 3 Day Pill For Men and Z-ROCK: Recall – Undeclared Drug Ingredient |
| |
CRM Laboratories is conducting a consumer/user level recall of all X-ROCK 3 Day Pill For Men and Z-ROCK products sold between October, 2011 and April, 2012. Analytical tests conducted by the FDA concluded that the products contained sildenafil and 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. 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. FDA advised 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm313177.htm
In Hong Kong, the above products are not registered pharmaceutical products. News regarding the product "X-Rock" has been released by the FDA and Health Canada and was posted on the website of Drug Office on 18 April, 23 April and 25 May 2012.
Ends/ Wednesday, July 25, 2012
Issued at HKT 12:00 |
| |
|
