Recall -- Firm Press Release
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International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement
International Pharmaceuticals, Ltd.
FOR IMMEDIATE RELEASE -- Bradford, MA - May 29, 2008 - International Pharmaceuticals, Ltd., P.O. Box 5165, Bradford, MA 01835, announced today that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.
International Pharmaceuticals, Ltd. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance. The use of undeclared chemicals pose a threat to consumers because they may harmfully 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 such nitrates.
VIP Tabs are sold in retail outlets nationwide and are packaged into 2-capsule blister packs and 8-capsule bottles.
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.
The Company advises that any unused portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions/questions obtained by calling (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/medwatch/report.htm.
The Company 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 it’s products, and is always concerned with the health of persons who may have consumed this product.
The Company sincerely 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 the composition of this product in the future.