Prolatisâ€™, of Salt Lake City, Utah, just announced it is conducting a voluntary nationwide recall of its product sold under the name <"https://www.yourlawyer.com/practice_areas/defective_drugs">Prolatisâ€™, the U.S. Food and Drug Administration (FDA) said.
Prolatisâ€™ is conducting the recall after being informed by the FDA that lab analysis found Prolatisâ€™ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This makes Prolatisâ€™ an unapproved drug. The active drug ingredient is not listed on the product label.
The recalled Prolatisâ€™ product was manufactured prior to August 9, 2010. Prolatisâ€™ is sold nationwide in double blister packs and 40 count bottles.
To date, no illnesses or adverse effects have been reported to the company in connection with this product.
The undeclared ingredient may pose a threat to consumers because the analogue 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Prolatisâ€™ advises any customer in possession of Prolatisâ€™ to return the product for a full credit towards the new product. Customers can call 1.877.286.5056 for instructions on the return and credit process.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].