Xtreme Ultimate Sexual Enhancer Recalled

Global Wellness, LLC. Hollywood, Florida just issued a nationwide recall of its <"http://www.yourlawyer.com/practice_areas/defective_drugs">Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men, the U.S. Food and Drug Administration (FDA) just announced. This recall has been implemented at the consumer level.

The product was distributed throughout the United States, Puerto Rico, and Canada to Internet and retail consumers and was distributed as a bottle containing six blue capsules per package. The label on the packaging lists the company name Global Wellness, LLC, Hollywood Florida. Only Lots 809013 and 806030 are involved in this recall.

The company has been informed by representatives of the FDA that laboratory analysis conducted by the agency for Lots 809013 and 806030 found that the product contains sulfoaildenafil methanesulfonate, sulfosildenafil, and dimethylsildenafil analogs of sildenafil. Silenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men an unapproved drug.

The active drug ingredient is not listed on the product label. The undeclared ingredient 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. Additionally, the product may cause side effects, such as headaches and flushing.

No illnesses have been reported to Global Wellness, LLC, to date, in connection with these products.

Customers in possession of the defective Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men are being advised by the FDA to stop using the recalled supplement immediately and contact their physician if they have experienced any problems that may be related to taking this product.

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 telephone at 1.800.FDA.1088; 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 by fax to 1.800.FDA.0178.

The firm may be reached at 1.954.922.1133, Monday through Friday, from 9:00 a.m. to 4:00 p.m., Eastern Standard Time (EST) for instructions on the return process.

This entry was posted in Legal News, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.