January 24, 2011
DAVIE, Fla.Kanec USA issued a statement that it is conducting a national voluntary recall of all lots of its Nite Rider Maximum Sexual Enhancer for Men and Stud Capsule for Men dietary supplements, after FDA informed the company that its testing found the products contained Sildenafil, a pharmaceutical drug used to treat erectile dysfunction (ED). Kanec issued a similar recall notice in April 2010, after FDA testing of a lot of Stud Capsules for Men found the product was also adulterated with Sildenafil.
The use of the adulterated products may pose a health concern to consumers, as the drug analogue can interact with nitrates found in other pharmaceuticals and lower blood pressure to dangerous levels. Kanec is advising consumers to discard the products or return them to the retail location of purchase. Consumers and health care providers can also report any adverse reactions to the products to FDAs MedWatch Adverse Event Reporting program online. The recall is being conducted with FDAs knowledge.
In its notice, the company stated it does test its raw materials and finished products but that previous testing protocols did not include a test for Sildenafil; it said the situation is being rectified. Further, Kanec said it promises to ensure quality and integrity" of its products.
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