Public Alert No. 030/2021 – Alert on Recall of All Unexpired Lots of Alpha Male Plus Male Enhancer fruit chews by Alpha Male Plus Due to the Presence of Undeclared Tadalafil and Sildenafil
August 17, 2021,
The National Agency for Food and Drug Administration and Control has been informed by the U.S. Food and Drug Administration that Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots of unexpired Alpha Male Plus Male Enhancer fruit chews. The result of analysis by FDA found the product to contain undeclared tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved product for the treatment of male erectile dysfunction.
The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established.
Alpha Male Plus Male Enhancer fruit chew is marketed as a dietary supplement for male sexual enhancement and sold online.
The undeclared tadalafil 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 Detail: The details of the recalled products are as follows;
Product Name: Alpha Male Plus Male Enhancer fruit chew, Alpha Male Plus, Dietary Supplementary
Product Description: Alpha Male Plus is packaged in 1strip per foil pouch within a cardboard box.
UPC: [8 60003 03770 6] [8 60003 74512 0]
Product Manufacturer: Alpha Male Plus
Affected Lots: All lots
NAFDAC implores consumers to stop the purchase and use of Alpha Male Plus. Members of the public in possession of the implicated product are implored to handover product 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 the implicated product.
NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via firstname.lastname@example.org, E- reporting platforms available on the NAFDAC website or via the Med- safety application available for download on android and IOS stores.