Bodee LLC, Inc., in conjunction with the FDA, announced they are recalling the dietary supplement Zencore Tabs because of undeclared ingredients.
Representatives of the FDA found these undeclared ingredients during lab analysis and stated that the ingredients are potentially harmful to consumers.
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.
Some consumers with conditions such as diabetes, who have high blood pressure, high cholesterol, or heart disease many need to take nitrates. Erectile Dysfunction is a common problem for men with these ailments, and some consumers may seek these kinds of products to better their sexual performance.
Zencore Tabs were sold in health food stores and through mail order across the U.S. and Canada. The product comes in a 2-capsule blister pack which is packaged in a booklet with five booklets in one box.
Bodee and the FDA are recommending that any consumer who is using Zencore Tabs should cease use immediately and should seek medical care if they are experiencing any problems. The company is working with the FDA to make sure their product will be safe in the future.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.