International Pharmaceuticals, Ltd. of Bradford, Massachusetts just announced that it is voluntarily recalling all of its supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving, after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by the agency of a sample from one lot of the product revealed it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil.
The FDA asserts that this ingredient is an analog of sildenafil, which is the active chemical ingredient of Viagra and other FDA-approved drugs used for Erectile Dysfunction (ED) in men to enhance sexual performance. According to an FDA release, the use of undeclared chemicals poses a threat to consumers because they may harmfully 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 such nitrates, says the FDA.
The International Pharmaceutical’s VIP Tabs are sold in retail outlets nationwide and are packaged into two-capsule blister packs and 8-capsule bottles.
Customers who have this product in their possession are warned to stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. International Pharmaceutical advises that any unused portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions/questions obtained by calling (800)-273-4137, Ext. 3. Also, any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.
We also reported this week that the FDA requested that SEI Pharmaceuticals of Miami, Florida recall all Xiadafil VIP Tabs sold in eight tablet bottles (Lot # 6K029) or blister cards of two tablets (Lot # 6K029-SEI). Florida officials issued a “stop sale” action at SEI’s Miami distribution facility on May 13 that required SEI to hold—intact—violative Xiadafil VIP Tabs found on-hand at the facility.
The Xiadafil VIP Tabs also contained the potentially harmful, undeclared ingredient that may dangerously affect a person’s blood pressure as well as cause other life-threatening side effects. The lots of Xiadafil VIP Tabs containing the potentially dangerous ingredient, bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and claim to treat erectile dysfunction (ED), are labeled as a dietary supplement, and hyped as “all-natural”; however, FDA Xiadafil VIP Tabs are, in fact, an illegally marketed drug.
The FDA said it has not approved either supplement for any use and safety and effectiveness of both products are unknown. According to the FDA, alternative products such as these are often sought out because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should be aware that the FDA has not verified the safety, efficacy, and purity of such ingredients.
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