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U.S. Department of Health and Human Services

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Viga Tablets (Best Life International) Press Release

This is the text of a letter from Best Life International. Contact the company for a copy of any referenced enclosures.


Best Life International, Inc.

VOLUNTARY RECALL OF VIGA TABLETS

May 23, 2003

Contact Person:
Alida Slentz
(787) 832-3287

Best Life International is warning its consumers not to purchase or consume the product known as Viga. This product which is being marketed as a dietary supplement contains the unlabeled drug ingredient sildenafil, which may pose possible serious health risks to some users. Viga is sold in bottles of 30 tablets which are distributed by Best Life International Inc. This product is being promoted for increasing desire, confidence and sexual performance. The product is sold without medical prescription.

The interaction between nitrates and sildenafil can result in profound and life-threatening lowering of blood pressure. The use of nitrates in any form is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate user is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers and patients with ischemic heart disease.

Consumers who have purchased Viga tablets are urged to immediately discontinue their use and return to their place of purchase or directly to Best Life International Inc. at Reparto Antillano, Calle 1ra # 188, Mayaguez, PR 00680. Consumers with questions regarding this recall may contact the company at 1-787-832-3287. Consumers who have purchased this product and have medical concerns should consult with their health care providers.

Any adverse reactions experienced with the use of this product should be reported to: U.S. Food and Drug Administration, San Juan District at 1-800-FDA-0127 or FDA’s Medwatch Program at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).