Kanec USA Inc. is voluntarily recalling all lots of its male enhancement capsules due to unapproved use of an erectile dysfunction drug that could lead to potentially dangerous drug interactions.
Kanec is conducting a recall of all lots of the company’s Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule for Men because they were found adulterated with sildenafil, an FDA approved drug used in the treatment of erectile dysfunction (ED), making the products unapproved new drugs. Representatives of the Food and Drug Administration (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 may seek these type 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. Mail to address on the pre-addressed form.
Fax: 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 it to Kanec USA, Inc. 5061 South State Road 7, Ste 602, Davie Fla. 33314.
Kanec USA, Inc. conducts stringent quality testing of its raw materials and finished products. Previous testing protocols did not include a test for the presence of Sildenafil or its analogues. Kanec USA Inc. assures consumers that this deficiency is being rectified. Kanec USA, Inc. apologizes for any inconvenience and expresses its concern for the health of consumers by conducting a voluntary recall action. Kanec USA, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.
