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When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. FOR IMMEDIATE RELEASE - April 26, 2023- West Sacramento, CA, Gear Isle is voluntarily recalling the following products listed in the table below to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as Phosphodiesterase Inhibitors (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in these products renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumption of products with undeclared 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.
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