SEI Pharmaceuticals' Xiadafil VIP Tabs are being recalled for containing a substance that could hurt patients.
The Food & Drug Administration has requested that SEI Pharmaceuticals of Miami, Fla., recall all Xiadafil VIP Tabs sold in eight-tablet bottles (Lot #6K029) or blister cards of two tablets (Lot # 6K029-SI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2008 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and for treating erectile dysfunction (ED). The formal request follows an action by the state of Florida to prevent the further distribution of this product into consumer channels. FDA is advising consumers not to buy or use this product. FDA chemical analysis revealed that Xiadafil VIP Tabs contain hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA advises consumers who have used this product to discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product. Consumers and healthcare professionals can report adverse events to the FDA's MedWatch program at 800 FDA-1088 or online at www.fda.gov/medwatch/report.htm. For more information, visit www.fda.gov/consumer/updates/erectiledysfuntion010498.html.