Nite Rider, STUD Dietary Supplements Recalled

Kanec USA Inc., announced today that it is conducting a voluntary recall of all lots of its <"http://www.yourlawyer.com/practice_areas/defective_drugs">Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule for Men because they were found to be adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED). This makes the products unapproved new drugs, said the U.S. Food and Drug Administration (FDA). Representatives of the FDA informed Kanec USA, Inc. of the laboratory analysis.

Use of these male enhancement herbal supplement capsule products may pose a threat to consumers because the drug 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 these men may seek these types of products to enhance sexual performance.

Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men are currently being distributed to wholesalers in Florida. The products are sold in a blister pack of one capsule per unit of use; 24 packets in a display box. Consumers who have either of these products in their possession should stop use immediately.

In the event of any adverse side effects due to the consumption of this product, consumers should contact a physician immediately.

Any adverse events that may be related to the use of this product should be reported to the FDA’s Medwatch program either online, by regular mail or by fax. 
Online: www.fda.gov/medwatch/report.htm; Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or by fax to 1-800-FDA-0178.

The company is advising consumers to discard any unused Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule For Men products or return them to the retail location from which it was purchased. Consumers wishing to return unused capsules directly to the company, may send the unused product to Kanec USA, Inc. 5061 South State Road 7, Ste 602, Davie Florida, 33314.

Kanec USA, Inc. said, wrote the FDA, that it conducts stringent quality testing of its raw materials and finished products, but that previous testing protocols did not include a test for the presence of Sildenafil or its analogues and said that this deficiency is being rectified.

This entry was posted in Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.