FDA Reports Recall of Drug Sold as Supplement

WASHINGTON—On June 18, the Food and Drug Administration (FDA) reported Long Weekend, a product sold as a dietary supplement, was being voluntarily recalled because it contains an undeclared drug. Its manufacturer, Port Washington, N.Y.-based Confidence Inc., initiated the recall after FDA found the product contained tadalafil, a pharmaceutical ingredient used as treatment for male erectile dysfunction.

Since Long Weekend has not been approved as a drug, FDA said its safety and effectiveness has not been determined. The agency further warned the product poses a threat to consumers because tadalafil can interact with nitrates found in some prescription drugs and might lower blood pressure to dangerous levels. Long Weekend was sold through by mail order and retailers nationwide, as well as in Puerto Rico, Canada, Britain, Russia and China. For more information, contact the company at (516) 767-1870 or [email protected].