| | S&B Shopper LLC is voluntarily recalling all lots of Imperial Extreme 2000mg capsules, to the consumer level. FDA analysis has found this product 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 Imperial Extreme 2000mg capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take Imperial Extreme 2000mg capsules 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, S&B Shopper LLC has not received any reports of adverse events related to this recall. The tainted product is marketed as a dietary supplement for male enhancement and is packaged in cardboard in a blister pack, 1 capsule per cardboard blister. The affected Imperial Extreme 2000mg lots include but are not limited to the following Expiration Date of 12/30/23. | | | |
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