Sexual Enhancement Supplements Recalled by Atlas

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A voluntary nationwide recall of sexual enhancement supplements has been announced by Atlas Operations Inc. The company is cooperating with the Food and Drug Administration (FDA), which found that the sexual enhancement products contained an ingredient not listed on the product label.

Specifically, a number of the company’s products were found to contain sulfoaildenafil, an analogue of sildenafil, a drug (Viagra) approved by the FDA for treatment of erectile dysfunction. The presence of sulfoaildenafil in these sexual enhancement supplements makes them an unapproved drug and also means they pose a potential threat to consumers because the analogue may interact with some prescription drugs (e.g., nitroglycerin) and lower blood pressure to a dangerous level. Men who have diabetes, high blood pressure, high cholesterol, or heart disease often take other prescriptions drugs and also frequently experience erectile dysfunction, for which some seek help from supplements such as those marketed by Atlas Operations.

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Atlas Operations is recalling dietary supplements sold under lot numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779, and 807. The list of sexual enhancement products being recalled is extensive and includes but is not limited to Aspire One, Sex Enhancer, Sexual Surge, Love Fuel, Erexa, 72 Hours, Red Hot Sex, Libiplus, and Staminil. Consumers should visit the FDA recall website (www.fda.gov/Safety/Recalls/ucm194074.htm) for a complete list of products.

Consumers who have purchased any of these products are urged to discontinue using them and to return them to their place of purchase. The products can also be returned directly to Atlas Operations. For instructions on how to return the supplements, consumers can call 1-800-466-4444 Monday through Friday from 9AM to 5 PM EST.

Atlas Operations has stated that it did not “in any way knowingly or intentionally violate the law with regard to the distribution” of their sexual enhancement products. Anyone who believes they have experienced an adverse reaction after using any of the Atlas sexual enhancement products on the recall list should report it to the FDA’s MedWatch Adverse Event Reporting program online (www.fda.gov/MedWatch/report.htm), by regular mail, or by fax.

SOURCE:
Food and Drug Administration recall news release, Dec. 11, 2009

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