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The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the general public of the voluntary recall of four brands of male sexual enhancement pills by their manufacturing companies. These recalls were as a result of Amazon notifying the FDA of the laboratory analysis which found the products to contain undeclared tadalafil and/ or sildenafil.
Sildenafil and tadalafil are ingredients known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved product for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in the products makes them unapproved drugs for which the safety and efficacy have not been established and therefore, subject to recall.
The implicated products are marketed as dietary supplements for male sexual enhancement and sold online (Amazon at www.amazon.com).
Possible Risk
The undeclared tadalafil or sildenafil ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers with underlying medical issues who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks as the PDE-5 inhibitors may interact with nitrates found in some of their prescription drugs.
Product Details
The details of the affected product are as follows;
The products are packaged in 10-count blisters, packaged in carton.
| Recalling Company | Product Name | Lot Number | Expiry date | UPC | ASIN |
| Junp LLC, Brooklyn, NY | MegMan Performance Booster capsules | 2010291 | 01/07/2024 | 8 48998 0091 2 | |
| ABC SALES 1 INC, Monsey, NY, | MAC DADDY RED and MAC DADDY RED Capsules | 1230004 and 1230005 | 03/30/2024 and
03/30/2024 |
742137605191
and 742137605764 |
B07TLDZLY2 and
B08Z63Z4QK |
| Your Favorite Shop, Jackson, NJ | The Red Pill | 26436989 | 10/30/2023 | B0847BSQQ5 | |
| Positive-Health, Wilmington DE, | Rise Up Red Edition Capsules | 48658908 | 9/9/23 | B08JCWG84D |
PRODUCT PHOTOS
NAFDAC implores consumers to stop the purchase and use of these products.
Members of the public in possession of the implicated products are implored to stop the sale or use and handover products to the nearest NAFDAC office.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using any of the implicated product.
NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of the products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng, E- reporting platforms available on the NAFDAC website or via the Med- safety application available for download on android and IOS stores.
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
