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.
TWC Global LLC, Inc. Issues a Voluntary Nationwide Recall of Axcil and Desirin Products Marketed as Dietary Supplements
TWC Global, LLC
FOR IMMEDIATE RELEASE -- Mountain View, CA -- September 12, 2007 -- TWC Global, LLC, 530 Showers Drive, Suite 7-129, Mountain View, CA 94040, announced today that it is conducting a voluntary nationwide recall of the company's supplement products sold under the names of Axcil and Desirin.
TWC Global is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Axcil and Desirin samples found the products contain potentially harmful, undeclared ingredients. FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of 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. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance.
Both Axcil and Desirin are sold on internet nationwide. The products are sold as a 15-capsule blister pack packaged in a box.
Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.
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 of the products be returned to TWC Global, LLC immediately for a full purchase price refund. The returning address is: TWC Global, LLC, 530 Showers Drive, Suite 7-129, Mountain View, CA 94040. Please return the unused portion of the product with invoice for refund. Consumers with questions may contact the company at 650-575-0828.
The Company is taking this voluntary action because it is committed and is always concerned with the health of consumers who have taken these products. The Company is reviewing the raw materials used to make these products and the raw material manufacturers and suppliers to identify the source of contamination to ensure that there will be no future issues with regard to Axcil and Desirin’s compositions. 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.