Atlas Operations, Inc. Issues a Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements

Date of Recall

2009-12-14

Recall Details

- December 11, 2009 - Pompano Beach, FL - Atlas Operations, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807.

These products are currently being sold as a dietary supplement throughout the U.S. Atlas Operations, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the products tested from certain batches of the following products Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09 contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products 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.

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