Contaminated herbal Viagra withdrawn
Intelli Health Products issued a recall for Duro Extend Capsules For Men, herbal products that list L-Arginine, Velvet Deer (antler), Maca Extract (root), Rhodiola Rosea and Sasparilla on-label.
The problem of contamination of erectile dysfunction supplements with unauthorized pharmaceutical ingredients such as sildenafil has drawn attention from regulators this year with both the Food and Drug Administration and Health Canada issuing warnings about contaminated products.
In the latest case, an FDA inspector notified Intelli Health Products that testing revealed its products were contaminated with Sulfoaidenafil, an analogue of Sildenafil.
Sildenafil is approved as an ED pharmaceutical, making Duro Extend Capsules For Men an unclassified drug.
The company, in a recall posted on the FDA website, said consumers who may have the product should stop using it immediately.
“Use of this product may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels,” it said.
“Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.”
