Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient

[UPDATED 12/06/2010] Nationwide recall of Duro Extend Capsules For Men expanded to include all lot codes.

[Posted 11/05/2010]

AUDIENCE: Consumer

ISSUE: Lab analysis has found Duro Extend Capsules for Men to contain Sulfoaidenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction, making the product an unapproved drug. The analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

BACKGROUND: Duro Extend Capsules are sold nationwide. The products are sold as a blister pack containing one capsule per unit of use, 24-packs in a box. Lot number and expiration date appear on the seal.

RECOMMENDATION: Consumers who have Duro Extend Capsules in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician immediately. See the company Press Release for lot number listing and product photos.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/02/2010 - Press Release - Intelli Health Products]
[10/27/2010 - Press Release - Intelli Health Products]