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Public Alert No. 015/2023 –Recall of PrimeZEN Black 6000 male enhancement capsules due to undeclared ingredients
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public that Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level.
The recall is following an FDA analysis which found PrimeZen Black 6000 capsules to contain undeclared ingredients (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 6000 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. 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.
Product details
The details of the product are as follows;
Product Name: PrimeZEN Black 6000 male enhancement capsules
Product Manufacturer: Volt Candy, 324 S. Diamond Bar Blvd #212, USA.
Lot Number: NPINPB 1003
UPC code: 728175521891
Expiration Date: Aug. 16, 2025
PrimeZen Black 6000 is 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.
See the pictures attached
Product Image
NAFDAC implores members of the public in possession of the above product to stop the sale or use of the product and handover product to the nearest NAFDAC office.
If you have this falsified product, please DO NOT use it. If you, or someone you know, have used the product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……….Customer-focused, Agency-minded!!!
Signed Management
