TOPIC: Pro Power Knight Plus, NUX Male Enhancement and DYNAMITE SUPER Capsules by Gear Isle: Recall - Due to the Presence of Sildenafil and Tadalafil
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: Gear Isle is recalling the following products:
- Pro Power Knight Plus Capsule 2550 mg - No lot number, Expiration date 06/2026
- NUX Male Enhancement Capsule - Lot # RO 927996, Expiration date 12/25/2024
- DYNAMITE SUPER Capsule 58,000 mg - Lot # OMS760-B, Expiration date 12/2025
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. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.
To date, Gear Isle has not received any reports of illness or adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: These products are marketed as dietary supplements for male sexual enhancement.
RECOMMENDATIONS:
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Consumers who have the products which are being recalled should stop using and return them for a refund.
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers with questions regarding this recall can contact the company's customer service.
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