The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public warning about the use of PrimeZen Black 6000mg, a male performance enhancement capsule that has been recalled from the market due to undeclared ingredients. In a public alert with No. 015/2023, NAFDAC’s Director-General, Prof Mojisola Adeyeye, cautioned users and consumers against using the product.
The recall was initiated by Volt Candy, the manufacturer of the product, due to the presence of undeclared ingredients found by the Food and Drug Agency (FDA) of the United States of America. The FDA’s analysis revealed that the PrimeZen capsules contained sildenafil and tadalafil, which 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 thus subject to recall. In her statement, Prof Adeyeye noted that PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs and may cause a significant drop in blood pressure that may be life-threatening.
“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,” said Prof Adeyeye. “People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.”
The product, PrimeZEN Black 6000 male enhancement capsules, was manufactured by Volt Candy at 324 S. Diamond Bar Blvd #212, USA. The lot Number for the recalled product is NPINPB 1003, with a UPC code of 728175521891, and an expiration date of Aug. 16, 2025. It is being marketed online as a dietary supplement for male enhancement and is packaged in a blister card with one capsule. The product can be identified by the card color in black with the name on it PrimeZen Black 6000.
NAFDAC urged members of the public in possession of the recalled product to stop selling or using it and to hand it over to the nearest agency office. The Director-General also advised against using the falsified product, warning of possible adverse reactions.
“If you, or someone you know, have used the product, or suffered any adverse reaction after use, please seek immediate medical advice,” she advised. “Healthcare professionals and consumers are advised to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office. The public is also advised to report any adverse reactions of the product to NAFDAC on 0800-162-3322 or via email: alert@nafdac.gov.ng“
PrimeZen Black 6000mg capsules recall by NAFDAC
The recall of PrimeZen Black 6000mg capsules is a significant move by NAFDAC to safeguard the health and safety of the public. The agency has been working tirelessly to ensure that all drugs and food products sold meet the required safety and quality standards. The public is encouraged to be vigilant and report any suspicious products to NAFDAC for prompt action.
In conclusion, it is essential to emphasize that the use of unapproved drugs poses a significant risk to health and safety. Consumers are urged to always verify the authenticity of drugs and food products before purchase, and to report any suspected cases of counterfeit or substandard products to NAFDAC.
