Sean Moloughney07.16.09
FDA action has led to the recall this week of several male enhancement products sold by two separate companies. The dietary supplements contain undeclared ingredients that FDA has approved as drugs for the treatment of erectile dysfunction (ED).
Los Angeles, CA-based Haloteco issued a voluntary recall of Libipower Plus on July 13—sold as a 1 capsule blister pack through distributors and retail stores in California—after FDA informed the company that lab analysis found the product contained tadalafil, which is the active ingredient in FDA approved drugs for ED. The undeclared ingredients 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. Additionally, the product may cause side effects such as headaches and flushing.
The other recall issued on July 15 involved six supplement products from Nature & Health Company, Brea, CA, sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule and Herbal Disiac.
FDA lab analysis indicated that samples contained tadalafil, its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug. None of the active drug ingredients are listed on product labels. The six recalled products were distributed in retail stores in California, Georgia, Illinois, Texas and Ohio.
According to the company, no illnesses have been reported to date in connection with these products.
In June, Stamina-RX brand dietary supplements from Hi-Tech Pharmaceuticals were recalled because FDA found they contain benzamidenafil—a drug that is not FDA approved but is categorized in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil.
Los Angeles, CA-based Haloteco issued a voluntary recall of Libipower Plus on July 13—sold as a 1 capsule blister pack through distributors and retail stores in California—after FDA informed the company that lab analysis found the product contained tadalafil, which is the active ingredient in FDA approved drugs for ED. The undeclared ingredients 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. Additionally, the product may cause side effects such as headaches and flushing.
The other recall issued on July 15 involved six supplement products from Nature & Health Company, Brea, CA, sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule and Herbal Disiac.
FDA lab analysis indicated that samples contained tadalafil, its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug. None of the active drug ingredients are listed on product labels. The six recalled products were distributed in retail stores in California, Georgia, Illinois, Texas and Ohio.
According to the company, no illnesses have been reported to date in connection with these products.
In June, Stamina-RX brand dietary supplements from Hi-Tech Pharmaceuticals were recalled because FDA found they contain benzamidenafil—a drug that is not FDA approved but is categorized in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil.