Good Health, Inc. of Canutillo, Texas, has issued a nationwide voluntary recall of its dietary supplement <"https://www.yourlawyer.com/practice_areas/defective_drugs">Vialipro, the U.S. Food and Drug Administration (FDA) just announced. Vialipro is marketed for sexual enhancement.
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 FDA that a lab analyses found that the product tested from certain batches of Vialipro contains Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This makes 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
All dates of Vialipro capsulesâ€”10-countâ€”sold under the following lot numbers are involved in the recall: 80409, 80661, 81146, 90132, 90265, 90587, 90826, 91065, 00197, and 00347.
Laboratory analysis identified that one of the raw ingredients was tainted with Sulfoaildenafil. Good Health, Inc. urges consumers who have purchased Vialipro to discontinue its use and return it to Good Health, Inc.
Customers can call Good Health, Inc., toll-free, at 1- 866-607-0338 Monday through Friday from 9:00 am to 5:00 pm, Mountain Standard Time, for instructions on the return and refund process. Distributors are advised to stop selling Vialipro and contact Good Health, Inc. at its toll-free number for further instructions.
Good Health, Inc. claims it 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 at www.fda.gov/MedWatch/report.htm; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm (mail the completed form to the address on the pre-addressed form); for by Fax to 1-800-FDA-0178.