Products found to contain undeclared medicines
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| The United States: Gear Isle issues voluntary nationwide recall of Pro Power Knight Plus, NUX Male Enhancement and DYNAMITE SUPER capsules due to the presence of sildenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that Gear Isle is voluntarily recalling the following products to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. The affected products are:
- Pro Power Knight Plus Capsule 2550 mg (no lot number)
- NUX Male Enhancement Capsule (lot number: RO 927996)
- DYNAMITE SUPER Capsule 58000 mg (lot number: OMS760-B)
Sildenafil and tadalafil are ingredients 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gear-isle-issues-voluntary-nationwide-recall-pro-power-knight-plus-nux-male-enhancement-and-dynamite
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 20 Apr 2023.
Ends/Thursday, Apr 27, 2023
Issued at HKT 18:00
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