The maker of Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men is recalling three lots of its product because it may lower blood pressure to dangerous levels in patients taking nitrates found in some prescription drugs such as nitroglycerin. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
The product has not gone through the U.S. Food and Drug Administration (FDA) approval process, and its active ingredient, sildenafil, is not listed on the product label.
The FDA advises persons who have the product to stop using it immediately and contact their physicians if they have experienced any side effects from the drug, including dangerously low blood pressure, headaches or flushing.
Sildenafil, the product’s main active ingredient, is an FDA-approved drug for erectile dysfunction. But, it has not been approved for use via Extreme Ultimate Sexual Enhancer dietary supplement.
The FDA conducted a laboratory analysis of the product and discovered it contained sildenafil and analogues (chemically similar compounds) of sildenafil. The recall was expanded to include lot A032111. Lot numbers 809013 and 806030 had been recalled previously.
The product has been distributed throughout the U.S., Puerto Rico, Barbados and Canada. It comes as a bottle containing six blue-colored capsules per package. The label on the package names the maker as Global Wellness, LLC, Hollywood, Florida.
Berkowitz and Hanna LLC is available to help people who believe they’ve been harmed by dangerous or defective drugs and products. For more information or to schedule a review of your case, please contact our Connecticut product liability attorneys today.