Recall -- Firm Press Release
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Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore Tabs, a Product Marketed as a Dietary Supplement
FOR IMMEDIATE RELEASE -- Century City, CA – August 31- Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, announced today that it is conducting a voluntary nationwide recall of all the company's supplement product sold under the name Zencore Tabs.
Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Zencore Tabs samples found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that one lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declares another lot of Zencore Tabs contains sildenafil, the active ingredient of another 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Zencore Tabs is sold in health food stores and by mail order nationwide and in Canada. The Zencore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a 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 Bodee LLC for a full purchase price refund by calling (800) 935-0296 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 Zencore Tabs’ 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.