Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Good Health, Inc. Issues a Nationwide Voluntary Recall of Product Marketed as Dietary Supplement
FOR IMMEDIATE RELEASE - July 16, 2010 - Canutillo, TX – Good Health, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement Vialipro for sexual enhancement sold under the Lot Numbers listed below.
This product is currently being sold as a dietary supplement throughout the U.S. Good Health, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. The active drug ingredient is not listed on the product label.
The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Vialipro Sold Under the Following Lot Numbers
Laboratory analysis identified that one of the raw ingredients was tainted with Sulfoaildenafil. Good Health, Inc. takes this recall very seriously and is committed to the diligent work required to ensuring its products remain free of any potentially unapproved chemicals. We take the utmost pride in our product quality control and have the highest regard for our customer's health.
We urge consumers who have purchased Vialipro to discontinue its use and return it to Good Health, Inc.. Customers can call Good Health, Inc. at 1 (866) 607-0338 Monday through Friday from 9:00 am - 5:00 pm MST for instructions on the return and refund process.
Distributors are advised to stop selling Vialipro and contact Good Health, Inc. at 1 (866) 607-0338 for further instructions.
It is the position of Good Health, Inc. that we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.
Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.