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Case Details for "Opteron 1 Inc. dba Nature & Health Co."

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Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements

Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared ingredients 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.

The six recalled products listed below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.

Customers who have these products 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.

 

Posted on:07/15/2009
Company: Opteron 1 Inc. dba Nature & Health Co.
Affected Class: n/a
Scope: Nationwide

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