Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted November 26, 2007
Encore Tabs Recalled -- Contain Prescription Drug
Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Encore Tabs samples found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that one lot of Encore 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. 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 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.
Encore Tabs is sold in health food stores, via the internet and by mail order nationwide and in Canada. The Encore 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.