Recall -- Firm Press Release
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Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products
Marketed as Dietary Supplements
Palo Alto Labs
FOR IMMEDIATE RELEASE -- Port St. Lucie, FL -- February 28, 2008- Palo Alto Labs, 265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984, announced today that it is conducting 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.
Palo Alto Labs conducts stringent quality control testing on both raw materials and finished products. Previous testing protocols did not include a test for the presence of Aildenafil or sulfoaildenafil but Palo Alto Labs assures consumers that this deficiency has been rectified. Palo Alto Labs apologizes for any inconvenience and expresses its concern for the health of consumers by conducting a voluntary recall action. Palo Alto Labs promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.