Intelli Health Recalls Mens Supplement
December 7, 2010
MIAMIIntelli Health Products issued a statement that it expanded its voluntary nationwide recall of Duro Extend Capsules for Men to include all lot codes. The company initiated the recall after it was informed by FDA that laboratory testing found the product to be adulterated with sulfoaidenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of erectile dysfunction (ED). Sulfoaidenafil can interact with other prescription drugs such as nitroglycerin, causing dangerous side effects.
Duro Extend Capsules were sold nationwide in individual blister packs, 12-pack and 24-pack display boxes, and in bulk in three-count and 10-count bottles. Consumers are advised to stop using the product immediately and to consult a health care professional in the case of any adverse side effects due to the consumption of Duro Extend Capsules. Consumers and health care professionals can report adverse events from the use of the product to the MedWatch Adverse Event Reporting program online.
In its statement, the company noted while it conducts testing of its raw materials and finished products, its previous testing protocols did not include a test for the presence of sulfoaidenafil. However, it is implementing measures to test for such adulterants, and is working closely with FDA on this recall.
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