Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Confidence, Inc. Issues a Voluntary Nationwide Recall of all lots of Long Weekend, a Product Marketed as a Dietary Supplement
FOR IMMEDIATE RELEASE -- June 14, 2007 -- 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.
Consumers should return any unused Long Weekend, for a refund of the full purchase price or price for the unused portion, to the Company's address in Port Washington, NY, or contact Jim Chao at 516-767-1870 or email email@example.com to receive further instructions for returning the product or with any questions.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178