The maker of Zencore Tabs, marketed as a dietary supplement to enhance male sexual stamina, is recalling the product because it contains undeclared ingredients including aminotadalafil and sildenafil, chemicals whose derivatives are used in prescription medicines for erectile dysfunction, the U.S. Food and Drug Administration said Friday.
These and two other chemical ingredients, sulfosildenafil and sulfohomosildenafil, may interact with nitrates found in certain prescription drugs and could lower blood pressure to dangerous levels, the FDA said in a statement.
Zencore is marketed by Los Angeles-based Bodee LLC.
Consumers who have this product are urged to stop using it immediately and to see a health-care professional if they notice any side effects, the FDA said.
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.The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Zencore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.
No comments:
Post a Comment