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Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a 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 and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared 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, Alpha Male Plus has not received any reports of adverse events related to this recall.
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