Intelli Health Products just announced that it is conducting a voluntary nationwide recall of <"http://www.yourlawyer.com/practice_areas/product_liability">Duro Extend Capsules For Men, the U.S. Food and Drug Administration (FDA) just reported.
Intelli Health Products was informed by representatives of the FDA that a laboratory analysis of Duro Extend Capsules For Men sample found the product to be adulterated with Sulfoaidenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED). This makes Duro Extend Capsules for Men an unapproved new drug.
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. 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. â€¨
Duro Extend Capsules are sold nationwide and are sold as a blister pack containing one capsule per unit of use with 24-packs in a box. Lot number and expiration date appears on the seal. â€¨
Lot Number and Expiration Dates:
â€¢ 80320A: 3/2011
â€¢ 80516A: 5/2011
â€¢ 80710A: 6/2011
â€¢ 80819: 8/2011
â€¢ 80519A: 8/2011
â€¢ 81104: 11/2011
â€¢ 81104A: 11/2011
â€¢ 81104B: 11/2011
â€¢ 90226A: 2/2012
â€¢ 90226: 2/2012
â€¢ 90226B: 2/2012
â€¢ 90612: 6/2012
Consumers with 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. Any adverse events that may be related to the use of these products should be reported to the FDA’s Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. or on the Med watch website at http://www.fda.gov/safety/medwatch/default.htm
The Company is advising consumers to return any unused Duro Extend Capsules, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can send unused capsules directly to the company at: Intelli Health Products; 80 Southwest 8th Street; Miami, FL 33130. Toll-free telephone: 1-800-861-6022.