U.S. Food and Drug Administration

 FDA MedWatch Program,  Jun 24, 2003

Voluntary Recall of Viga or Viga for Women Tablets

FOR IMMEDIATE RELEASE --Paramount, CA-- June 24, 2003 ---Health Nutrition (RMA Labs) is warning its consumers not to purchase or consume the product known as VIGA or VIGA FOR WOMEN. These products which are 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, and in packet of 4 tablets (ten packets in one small box). VIGA for women is sold in bottle of 20 tablets. Both products are distributed by Health Nutrition (RMA Laboratories Inc) and 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 is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate user is real since sexual dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers and patients with ischemic heart disease.

Consumers who have purchased Viga or Viga for women tablets are urged to immediately discontinue their use and return them to their place of purchase or directly to Health Nutrition (RMA Laboratories), 6439 Alondra Blvd, Paramount, CA 90723. Consumers with questions regarding this recall may contact the company at 1-562-616-0100. Consumers who have purchased this product and have medical concerns should consult with their health care provider.

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

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