HSA Medical Officer of Health, Dr. Kiran Kumar has released an advisory of the voluntary recall of all Zencore Tabs, a product marketed as a dietary supplement by its manufacturers, amid concerns that the product could contain potentially harmful, undeclared ingredients.
There are concerns that undeclared chemicals in the product could interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure levels to dangerous levels.
Mr. Kumar said customers who have Zencore tabs should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking the product.
Zencore manufacturer Bodee LLC launched the recall Monday after US Food and Drug Administration lab analysis revealed potentially harmful, undeclared ingredients.
The FDA asserts that its chemical analysis revealed that one lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of an FDA-approved drug used for Erectile Dysfunction.
The 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 analogs of sildenafil.
According to an FDA statement, 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.
The Zencore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.
Bodee LLC 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.
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