Bodee LLC, Inc., in conjunction with the CPSC, is recalling its dietary supplement product sold under the name Encore Tabs.
The drug was recalled after the FDA found that one lot of Encore Tabs contained a potentially harmful undeclared ingredient called aminotadala. Aminotadala is an analog of tadalafil, which is the main ingredient in Erectile Dysfunction (ED) drugs.
FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have health problems such as diabetes, high blood pressure, high cholesterol. or heart disease generally take medicines that contain nitrates. The people often have problems with ED and may be more likely to take these supplements.
The recalled product was available in health food stores, on the Internet and through mail order in the U.S. and in Canada. The pills came in a 2-capsule blister pack in a large booklet with five individual booklets in a box. The FDA recommends that anyone using this product should stop taking it immediately and contact a doctor if they have experienced any adverse health effects.
For more information on this subject, please refer to our section on Defective and Dangerous Products.