Urgent Recall: All Lots of Viapro 375 mg CapsulesAug 1, 2008 | Parker Waichman LLP
In the second such recall we are reporting on this week, EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of Viapro, a supplement sold in 375mg capsules.
EG Labs initiated the recall after being informed by the Food and Drug Administration (FDA) that lab analysis by the agency of a sample from one lot of Viapro revealed that Viapro contained a potentially harmful undeclared ingredient, thio-methisosildenafil, which the FDA has declared to be an analog of sildenafil, the active chemical ingredient in an FDA-approved drug used for Erectile Dysfunction (ED), like Viagra, in men to enhance sexual performance.
ED is a common problem in men with diabetes, high blood pressure, high cholesterol, or heart disease. These patients are often advised against taking ED drugs and may look for alternative products because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. The use of undeclared chemicals poses a threat to these 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.
Viapro capsules—which have not been sold since March 2008—were sold in retail outlets nationwide and packaged into two-capsule blister and one-capsule blister packages and in10-capsule bottles.
Customers should stop using Viapro immediately and contact their physician if they have experienced any problems that may be related to taking Viapro. Also, consumers are asked to return the product for a full refund to: Seaboard Tampa Terminal: 6708 Harney Road Tampa Florida, 33610. Any adverse events that may be related to the use of Viapro should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or online at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
Meanwhile, we have long been reporting on the issue of erectile dysfunction supplements containing undeclared ingredients. Most recently, in a move made at the request of the FDA, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets from lots 6K029 and 6K209-SEI. The supplements were distributed by SEI Pharmaceuticals, Inc. (SEI) of Miami, Florida. Earlier this month, Jack Distribution, LLC of Pompano Beach, Florida—and its wholesale distributors G & N Works, Inc, and Devine Distribution Inc.—issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion and Rose 4 Her capsules. In May, International Pharmaceuticals, Ltd. of Bradford, Massachusetts recalled lots of its supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs and SEI Pharmaceuticals of Miami, Florida recalled lots of Xiadafil VIP Tabs. All these recalls were implemented after samples were found to contain a potentially harmful undeclared ingredient, an analog of a chemical used in an FDA-approved ED medication.