Drug Litigation Newsroom

Drug Recalled Due To Undeclared Tadalafil

Confidence, Inc. of Port Washington, NY, announced today that it is conducting a voluntary nationwide recall of the Company's supplement product sold under the name Long Weekend. The Company has been informed by the Food and Drug Administration (FDA) that lab analysis of Long Weekend samples found that the product contains undeclared tadalafil, an FDA approved drug used as treatment for male Erectile Dysfunction (ED). The FDA has not approved Long Weekend as a drug; therefore the safety and effectiveness of this product is unknown.

FDA advises that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing. Consumers should discontinue use of Long Weekend and consult their health care professional about approved treatments for erectile dysfunction (ED). FDA encourages men who experience ED to seek guidance from a health care professional. The product was sold through mail orders and retailers located nationwide, in Puerto Rico, Canada, the United Kingdom, Russia, and China.

The recalled Long Weekend is sold in 3-capsule boxes. The capsules are sealed in a foil blister-pack, and the blister-pack is stamped with the LOT # and EXP date. The product is sold under the American Best Nutrition label and bears UPC 809515-0542. No illnesses have been reported to the Company to date in connection with this product. Confidence, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Confidence Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.