Manufacturer Expands Recall of Product Containing Sildenafil Analogue

December 9, 2010 9:07 am

Intelli Health Products is expanding a voluntary nationwide recall of Duro Extend Capsules For Men, to include all lots, after being informed by Food and Drug Administration (FDA) that laboratory analysis of Duro Extend Capsules For Men found the product to be adulterated with sulfoaidenafil. Sulfoaidenafil is an analogue of sildenafil which is an FDA-approved drug used in the treatment of erectile dysfunction (ED), making Duro Extend Capsules For Men an unapproved new drug. Sulfoaidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA advises that patients who have Duro Extend Capsules in their possession stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact their health care provider. FDA also encourages that any adverse reactions associated with the use of this product be reported to the FDA's MedWatch Adverse Event Reporting program. An FDA notice provides more information.