Dietary Supplement Zencore Tabs RecalledMar 23, 2009 | Parker Waichman LLP Bodee LLC, Inc. of Century City, California has just issued a voluntary, nationwide recall of all of its Zencore Tabs, the U.S. Food and Drug Administration (FDA) announced. The recalled Zencore Tabs are marketed as a dietary supplement.
Bodee LLC of 2222 Avenue of the Stars, 702E, Century City, CA 90067, is conducting this recall after being informed by representatives at the FDA that laboratory analysis by the agency of the Zencore Tabs samples found potentially harmful, undeclared ingredients. The FDA asserts that its chemical analysis revealed that one lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil. Tadalafil is the active ingredient of an FDA-approved drug that is used to treat Erectile Dysfunction (ED).
The FDA maintains that Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. The FDA also declares that another lot of Zencore Tabs contains sildenafil, the active ingredient of another FDA-approved drug used for the treatment of ED, as well as sulfosildenafil and sulfohomosildenafil; both are analogs of sildenafil.
We have long been reporting on the issue of erectile dysfunction supplements containing undeclared ingredients. This issue is of particular and serious concern because ED is a common problem in men with diabetes, high blood pressure, high cholesterol, or heart disease. These patients are often advised against taking ED drugs and may look for alternative products because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. The use of undeclared chemicals poses a threat to these consumers because they may harmfully 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 such nitrates.
Zencore Tabs are sold in health food stores and by mail order in the United States and in Canada. The Zencore Tabs product is sold as a two-capsule blister pack packaged in a retail booklet with five booklets in a box.
The FDA is urging customers who have the recalled Zencore Tabs in their possession to immediately stop using it and contact their physician if they have experienced any problems that may be related to taking the recalled Zencore Tabs. The FDA also advises consumers that any adverse events that may be related to the use of this product be reported to the FDA's MedWatch Program by telephone, toll-free at 1-800-FDA-1088; by toll-free fax at 1-800-FDA-0178; or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland, 20852-9787.
Bodee LLC is also advising consumers that any unused portion of the recalled Zencore Tabs be returned to it for a full purchase price refund by calling the firm toll-free at 1-800-935-0296 for instructions on the return and refund process.