Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men: Recall - Undeclared Drug Ingredient
ISSUE: FDA laboratory analysis confirmed that Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men contain Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making the products unapproved new drugs. Use of these male enhancement herbal supplement 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.
BACKGROUND: Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men are marketed as dietary supplements. They 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.
RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/18/2011 - Press Release - Kanec, USA]