June 17, 2009 -- Hi-Tech Pharmaceuticals Inc. of Norcross, Ga., is recalling all lots of its dietary supplement Stamina-Rx because it contains an unapproved drug, benzamidenafil, which may pose health risks.
Benzamidenafil, which isn't noted on the Stamina-Rx label and it isn't approved by the FDA, belongs to the same class of drugs as the active ingredients in the erectile dysfunction drugs Viagra, Cialis, and Levitra.
"Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil 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 and may be most susceptible to adverse effects from this product," states a Hi-Tech Pharmaceuticals news release posted on the FDA's web site.
FDA tests showed benzamidenafil in one lot of Stamina-Rx, but all lots of the product are being recalled because it is "an unapproved and misbranded drug," states Hi-Tech Pharmaceuticals. The company notes that Stamina-Rx is mainly sold in health food and drug stores nationwide.
Hi-Tech Pharmaceuticals advises consumers to stop using Stamina-Rx immediately and report any adverse effects to the company by calling 888-855-7919 from 9 a.m. to 5 p.m. Eastern time; consumers may also contact the FDA's MedWatch program in any of the following ways:
- Online: Visit the FDA MedWatch web site
- Phone: Call 800-FDA-1088
- Fax: Download FDA form 3500 and fax it to 800-FDA-0178
- Mail: Download FDA form 3500 and mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787