In December we wrote about a nationwide recall of the Atlas Operationsâ€™ dietary supplements for sexual enhancement. Now, Atlas Operations, Inc. just announced it is expanding its December 12, 2009 voluntary nationwide recall of the companyâ€™s dietary supplements for sexual enhancement to include <"https://www.yourlawyer.com/practice_areas/defective_drugs">Stamin It, Erectzia, and Vigor 100, according to the U.S. Food & Drug Administration (FDA). These products were sold as dietary supplements throughout the United States.
Atlas Operations, Inc. is conducting a voluntary recall after being informed by the FDA that lab analyses found that the products contain Sulfoaildenafil, an analogue of Sildenafil, which is an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label.
Of note, 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 and ED is a common problem in men with these conditions; consumers may seek these types of products to enhance sexual performance.
The recalled products are in capsule form and may be packaged in blisters, pouches or bottles. All expiration dates of the products are included in this recall. A complete list of recalled products and important information regarding lot numbers can be accessed at the FDAâ€™s Web site at: http://www.fda.gov/Safety/Recalls/ucm208537.htm
Consumers who have purchased these products are strongly urged to discontinue their use and return the product to its place of purchase. These recalled products can also be directly returned to Atlas Operations, which can be reached, toll-free, at 1-800-466-4444 Monday through Friday from 9:00 am to 5:00 pm Eastern Standard Time. Instructions on the return and refund process can be obtained at this toll-free number.
Adverse reaction or quality problems experienced with the use of this product may be reported to the FDAâ€™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, which is to be mailed to the address on the pre-addressed form. Fax: 1-800-FDA-0178.