Ultra Health Laboratories and Bionate International are warning consumers not to purchase or consume a product known as Vinarol tablets.
The product, being marketed as a dietary supplement designed to increase sexual performance, contains the unlabeled prescription drug ingredient, sildenafil, (also used in the Viagra drug) which could pose serious health risks to some users, said the Food and Drug Administration, involved in the recall.
Vinarol is marketed in tablet form in blister packages of 2 and 7 tablets. The product is being 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, according to the FDA. 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, it continued.
Consumers who have purchased Vinarol tablets have been asked to immediately discontinue their use and return them to their place of purchase or directly to the manufacturers.
The sildenafil got mixed into Vinarol either through employee tampering or a shipment of tainted herbs from China, according to an Associated Press story. The recall includes around 750,000 tablets but FDA officials said the number could reach into the millions.
Ultra Health Products and Bionate International have not however received any reports of injury or adverse reactions from the use of the product.