Herbal Mix That Contains Viagra Recalled
Posted on: Monday, 7 April 2003, 06:00 CDT
WASHINGTON (AP) -- A Phoenix company is recalling a product called Vinarol that claims to be a sexually stimulating herbal mix but also contains the prescription ingredient found in Viagra - posing a potentially life-threatening risk to certain users.
Consumers should not take the recalled Vinarol tablets, but return them to the place of purchase for a refund, said manufacturer Ultra Health Products Inc.
The problem: Food and Drug Administration investigators last week discovered sildenafil, the active ingredient in impotence-treating Viagra, in Vinarol last week.
It is illegal for prescription drugs to be sold in the guise of dietary supplements. More important, FDA pushed for an immediate recall because taking the drug-laced Vinarol could cause a potentially deadly reaction in heart disease patients who also use nitrates to treat chest pain.
Patients with heart disease frequently have impotence, and Vinarol is promoted as an herbal mix that increases sexual desire and performance - a claim that caught the attention of FDA inspectors who investigate dietary supplements that promise drug-like action.
The sildenafil got mixed into Vinarol either through employee tampering or a shipment of tainted herbs from China, said Ultra Health spokeswoman Laura Gillette. She said the company recently received a new shipment of herbs from China that independent testing found drug-free, and thus she hopes to soon begin selling a new batch of Vinarol.
Gillette said the recall includes 750,000 tablets; FDA officials said the number could reach into the millions. Vinarol was sold through the Internet and in stores around the country.
FDA has begun a criminal investigation of the drug-tainted supplement.
Agency officials said they knew of no illnesses linked to the product. Side effects can be reported to FDA at 1-800-FDA-1088. Consumers with questions about the recall may contact Ultra Health at 1-800-796-1150.
Ultra Health issued the recall together with Bionate International Inc., a previous maker of Vinarol.
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