Intelli Health Products announced today that it is expanding its voluntary nationwide recall of Duro Extend Capsules For Men, to now include all lot codes, the U.S. Food and Drug Administration (FDA) just announced. Intelli Health Products is conducting this recall after being informed by representatives of the FDA that laboratory analysis of Duro Extend […]
Intelli Health Products announced today that it is expanding its voluntary nationwide recall of <"https://www.yourlawyer.com/practice_areas/defective_drugs">Duro Extend Capsules For Men, to now include all lot codes, the U.S. Food and Drug Administration (FDA) just announced.
Intelli Health Products is conducting this recall after being informed by representatives of the FDA that laboratory analysis of Duro Extend Capsules For Men found the product to be adulterated with Sulfoaidenafil, an analogue of Sildenafil, which is an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making it 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.
Duro Extend Capsules are sold nationwide. The products are sold individually as a blister pack containing one capsule per unit, in 12-pack or 24-pack display boxes, and in bulk in three-count and 10-count bottles. Lot number and expiration dates appear on the seal. 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 reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: http://www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178
Intelli Health Products 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; Suite 2000; Miami, Florida; 33130. Intelli Health can also be reached, toll-free, at 1-800-861-6022.
Intelli Health Products stated that it conducts stringent quality control testing on both raw materials and finished products and that previous testing protocols did not include a test for the presence of Sulfoaidenafil. Intelli Health Products said it assures consumers that this deficiency is being rectified, apologizes for any inconvenience, and expresses its concern for the health of consumers by conducting a voluntary recall action.
