The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned Nigerians over the use of PrimeZen Black 6000mg, a male performance enhancement capsule.
This follows the recalling of the drug from the market by the Food and Drug Agency (FDA) of the United States of America.
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NAFDAC’s recall is contained in a public alert with No. 015/2023, signed by its Director-General, Prof Mojisola Adeyeye, and issued to the News Agency of Nigeria (NAN) in Abuja, on Sunday, May 14.
Adeyeye said that Volt Candy is voluntarily recalling the one lot of PrimeZen Black 6000mg capsule alongside its 2000mg, due to undeclared ingredients they were made of by their manufacturer in America.
She said: “The recall followed the analysis of Food and Drug Agency (FDA) of the United States of America, an FDA, which found the PrimeZen capsules to contain undeclared tadalafil and sildenafil.
“Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction.
“The presence of sildenafil and tadalafil in PrimeZen Black 6000mg capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
“Risk Statement, PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening.
“People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.