Bodee recalls Zencore after FDA finds undeclared drugs in chemical analysis
CENTURY CITY, Calif. Bodee last month voluntarily recalled all of the company’s supplement product sold under the name Zencore Tabs after being informed by representatives of the Food and Drug Administration that lab analyses found the product contained potentially harmful, undeclared pharmaceutical ingredients.
FDA asserted that its chemical analysis revealed that one lot of Zencore Tabs contained aminotadalafil, an analog of tadalafil, the active ingredient in Eli Lilly’s Cialis erectile dysfunction medication.
FDA maintained that Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declared another lot of Zencore Tabs contained sildenafil, the active ingredient found in Pfizer’s Viagra, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil.
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.