Kanec USA Recalls Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men Male Enhancement Herbal Supplement Capsules

 

Kanec USA, Inc. Issues a Voluntary Recall of Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men Male Enhancement Herbal Supplement Capsules Marketed as Dietary Supplements. 

Contact:
Kanec USA, Inc. kanecusainc@bellsouth.net

FOR IMMEDIATE RELEASE - January 18, 2011 - Kanec USA Inc., announced today that it is conducting a voluntary 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.

Atlas Operations, Inc. Expands The Recall Of Sexual Enhancement Products To Include Stamin It, Erectzia, and Vigor 100.

[UPDATED 04/14/2010] Atlas Operations, Inc. notified consumers of an expansion of its December 2009 voluntary nationwide recall of dietary supplements for sexual enhancement to include Stamin It, Erectzia, and Vigor 100. 
[Posted 12/15/2009] Atlas Operations, Inc. and FDA notified consumers of a nationwide recall of the company's dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. FDA lab analyses found that the products tested from certain batches contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making these products unapproved drugs. The active drug ingredient is not listed on the product labels.
The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs.  Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Read the company Press Release for a complete list of product names and lot numbers.
The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm¹], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms²" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
[04/12/2010 - Press Release³ - Atlas Operations, Inc.]
[12/11/2009 - Press Release⁴ - Atlas Operations, Inc.]

Former unapproved Drug list
  

Dietary Supplements Sold Under Lot Numbers

Lot Number ###-494-##
Brand Name	Packaging	Expiration Date
Aspire One	Capsules, all counts	All Dates
Lot Number ###-520C-##
Brand Name	Packaging	Expiration Date
Sex Enhancer	Capsules, all counts	All Dates
Lot Number ###-520B-##
Brand Name	Packaging	Expiration Date
Staminil	Capsules, all counts	All Dates
Sexual Surge	Capsules, all counts	All Dates
Love Fuel	Capsules, all counts	All Dates
Lot  Number ###-520A-##
Brand Name	Packaging	Expiration Date
Staminil	Capsules, all counts	All Dates
Sexual Surge	Capsules, all counts	All Dates
Love Fuel	Capsules, all counts	All Dates
Lot Number ###-520-##
Brand Name	Packaging	Expiration Date
Vaxitrol	Capsules, all counts	All Dates
Lot Number ###-521-##
Brand Name	Packaging	Expiration Date
Love Fuel 2	Capsules, all counts	All Dates
Lot Number ###-705-##
Brand Name	Packaging	Expiration Date
Erexa	Capsules, all counts	All Dates
Zenerect	Capsules, all counts	All Dates
Arousin	Capsules, all counts	All Dates
72 Hours	Capsules, all counts	All Dates
Bulk- Unlabeled	Capsules, all counts	All Dates
Enhancement	Capsules, all counts	All Dates
Red Hot Sex	Capsules, all counts	All Dates
Sexual Surge	Capsules, all counts	All Dates
Libiplus	Capsules, all counts	All Dates
Erexxx	Capsules, all counts	All Dates
Tacktol	Capsules, all counts	All Dates
Amour for him	Capsules, all counts	All Dates
Erousa	Capsules, all counts	All Dates
Rockhard	Capsules, all counts	All Dates
Staminil	Capsules, all counts	All Dates
Ezerex	Capsules, all counts	All Dates
Topviril	Capsules, all counts	All Dates
Vierect	Capsules, all counts	All Dates
APL	Capsules, all counts	All Dates
Clyamax	Capsules, all counts	All Dates
Lot Number ###-706-##
Brand Name	Packaging	Expiration Date
Love Fuel	Capsules, all counts	All Dates
Rainbow Rocket	Capsules, all counts	All Dates
Finally On Demand	Capsules, all counts	All Dates
Xtremexcite	Capsules, all counts	All Dates
Whatzup	Capsules, all counts	All Dates
Lot Number ###-807-##
Brand Name	Packaging	Expiration Date
Depth Charge	Capsules, all counts	All Dates