U.S. Food and Drug Administration

 FDA MedWatch Program,  Apr 4, 2003

ULTRA HEALTH LABORATORIES, INC. AND BIONATE INTERNATIONAL, INC. WARN CONSUMERS AGAINST TAKING THEIR DIETARY SUPPLEMENT PRODUCT WITH THEIR VOLUNTARY RECALL OF VINAROL TABLETS

Ultra Health Laboratories, Inc. and Bionate International, Inc. are warning consumers not to purchase or consume a product known as Vinarol tablets. This product, which is being marketed as a dietary supplement, contains the unlabeled prescription drug ingredient, sildenafil, which may pose possible serious health risks to some users. Vinarol is marketed in tablet form in blister packages of 2 and 7 tablets and is labeled as distributed by Ultra Health Laboratories, Inc. and/or Bionate International, Inc. The product is being promoted for increasing desire, confidence and sexual performance and is sold over the counter, as well as, via the Internet.

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 users 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 Vinarol tablets are urged to immediately discontinue their use and return them to their place of purchase or directly to Ultra Health Laboratories, Inc. at 3249 East Harbour Drive, Phoenix, Arizona 85034. Purchasers with questions regarding this recall may contact the company toll free at 1-800-796-1150. Consumers who have used this product and have medical concerns should consult with their health care providers.

Ultra Health Products, Inc. and Bionate International, Inc. to date have not received any reports of injury or adverse reactions from the use of this product.

Any adverse reactions experienced with the use of this product should be reported to FDA's MedWatch program by phone at 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, or by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

This recall is being made in cooperation with the U.S. Food and Drug Administration.

This advisory was prepared by the FDA MedWatch Program.
The text is a press release from Ultra Health Laboratories, Inc.