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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

KG Enterprises LLC, Inc. Issues A Voluntary Nationwide Recall of All Maxidus pills, a Product Marketed as a Dietary Supplement

 

Contact:
KG Enterprises LLC
1-866-373-2488

 

FOR IMMEDIATE RELEASE -- March 31, 2008 -- El Dorado Hills, CA -- KG Enterprises LLC, PO Box 5156, El Dorado Hills, CA 95742, announced today that it is conducting a voluntary nationwide recall of Maxidus, a product manufactured in Malaysia and distributed by KG ENTERPRISES, LLC.

KG Enterprises LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by the FDA of Maxidus pills samples found the product contain sildenafil and tadalafil, potentially harmful, undeclared ingredients. The FDA asserts that its chemical analysis revealed that the Maxidus pills contains sildenafil, the active ingredient of another FDA-approved drug used for Erectile Dysfunction (ED) an analog of sildenafil. These undeclared chemicals pose a threat to consumers because they 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.

Up until December 2007, Maxidus pills was sold by mail order, and via the internet, nationwide and worldwide. The Maxidus pills product is sold as a 10-capsule blister pack packaged in a gold box.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product 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 advises that any unused portion be returned to KG Enterprises LLC for a full purchase price refund by calling (866) 373-2488 for instructions on the return and refund process.

The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Maxidus pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

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