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Posted March 4, 2008

Two Supplements Recalled for Containing Viagra-like Compounds

On March 4, 2008, the FDA posted a release from Palo Alto Labs (dated February 28) announcing a voluntary nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite. Palo Alto Labs is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Sulfoaildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. This may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Aspire36 and Aspire Lite are sold nationwide. The products are sold as a blister pack containing one liquid capsule or a bottle containing either three (3) or twelve (12) liquid capsules.

Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The Company is advising consumers to return any unused Aspire36 and Aspire Lite, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can call 1-(877)240-3340 for instructions on the return and refund process.