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Public Alert No.023/2021 – Miracle8989 Issues Voluntary Nationwide Recall of PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, Due to Presence of Undeclared Sildenafil and Tadalafil

July 8, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the U.S Food and Drug Administration that Irving, Texas, Miracle8989 is voluntarily recalling all lots of PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, capsules to the consumer level. FDA analysis has found the products to contain undeclared sildenafil and tadalafil.  Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.  The presence of Sildenafil and Tadalafil in PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Consumers with underlying medical issues who take PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 with undeclared Sildenafil and Tadalafil may experience serious health risks.  For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.  Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Ebay Seller Annie Cho has not received any reports of adverse events related to this recall.

Sildenafil and tadalafil are known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction. These tainted products are marketed as a dietary supplement for male sexual enhancement.

COMPANY NAME PRODUCTS LOT NUMBER
Miracle8989 PremierZen Gold 7000 728175421832
Miracle8989 PremierZen Platinum 8000 728175421832
Miracle8989 MaxxZEN Platinum 12000 718122040728

Recommendations

NAFDAC implores consumers, distributors, importers in possession of the recalled PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 to discontinue sale or use and handover remaining stock to the nearest NAFDAC office.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of any Medicines and other regulated products to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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