Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements Expanded

Pompano Beach, FL–(ENEWSPF)–April 14, 2010.  Atlas Operations, Inc. announced today that it is expanding its December 12, 2009 voluntary nationwide recall of the company’s dietary supplements for sexual enhancement to include Stamin It, Erectzia, and Vigor 100.

These products were sold as dietary supplements throughout the United States.   Atlas Operations, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, 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.

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.

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.

Complete List of Recalled Products and Lot Numbers

*Consumers can identify recalled products by the 3 or 4 digit code located in the middle of the lot numbers noted above, where “#” represents any alphanumeric digit.  Additionally, the lot numbers may or may not contain dashes.

Our laboratories have identified that one of the raw ingredients was tainted with Sulfoaildenafil.   Atlas Operations takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals.  We take the utmost pride in our products’ quality control without compromising our customer’s health.

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase.  You may also return products directly to Atlas Operations.  Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am – 5:00 pm EST for instructions on the return and refund process.

It is the position of Atlas Operations, 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.

 

Source: fda.gov