"Viril-ity-Power" (VIP) Tabs, 560 mg

International Pharmaceuticals announced on May 30, 2008, that the company is conducting a voluntary recall of all the company's supplement product sold under the brand name of "Viril-ity-Power" (VIP) Tabs, 560 mg.

According to the company's press release, International Pharmaceuticals is conducting this recall after being informed by the U.S. Food and Drug Administration (FDA) that an FDA lab analysis of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil.

As previously reported, the FDA asserts that this ingredient is an analog of sildenafil (Viagra), an FDA-approved drug used for erectile dysfunction (ED) in men to enhance sexual performance. Many HIV positive patients as well as HIV negative individuals use Viagra for ED.

Use of the undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrate medications.

VIP Tabs are sold in retail outlets nationwide, as well as over the Internet, and are packaged in 2-capsule blister packs and 8-capsule bottles.

Consumers 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.

The company advises that any unused portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions obtained by calling 1-800-273-4137, Ext. 3.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov.

The company said it is working closely with the FDA in the recall process and is taking this voluntary action because it is committed to the quality and integrity of its products. The press release added that the company regrets any inconvenience to consumers and is reviewing the procedures and policies of all firms involved with the manufacture of this product to ensure that there will be no subsequent issues with regard to its composition in the future.

6/03/08

Source
International Pharmaceuticals, Ltd. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement. Press Release. May 30, 2008.