Products found to contain undeclared medicines
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| The United States: Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient Sildenafil |
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Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) and sildenafil is not listed on the product labels.
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
These products are intended to be used as a dietary supplement and sexual supplement. 72HP is packaged in a single blister pack containing 1 dose. Evil Root is packaged in box containing a bottle of 6 pills. Pro Power Max is packaged in a single blister pack containing 1 dose. All lots of 72HP, Evil Root and Pro Power Max are included in this recall. Consumers and retailers that have the 72HP, Evil Root or Pro Power Max supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm366524.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Wednesday, August 28, 2013
Issued at HKT 14:00 |
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