Products found to contain undeclared medicines
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| The United States: Health Fixer issues voluntary nationwide recall of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro due to undeclared chloropretadalafil, propoxyphenylsildenafil and sildenafil |
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The United States Food and Drug Administration (FDA) announces that Health Fixer is voluntarily recalling all lots of dietary supplements by the name of Male Ultra (lot number: KT-1ST-43-0110-2025), Malextra (lot number: KT-1ST-43-0104/2026), Electro Buzz (lot number: KT-1ST-43-0107/2024), Ultra Armor (lot number: KT-1ST-43-0110/2025) and Male Ultra Pro (lot number: KT-1ST-43-0110/2025) blister packs of 10 capsules per box/carton to the consumer level. Laboratory analysis has found the products to be tainted with chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Sildenafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Chloropretadalafil and propoxyphenylsildenafil are analogues of PDE-5 inhibitors and are likely to carry the same clinical risks. Products containing chloropretadalafil, propoxyphenylsildenafil, and sildenafil cannot be marketed as dietary supplements. These products are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of products with undeclared PDE-5 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 this product, adult males who use nitrates for cardiac conditions are most at risk.
The tainted capsules are marketed as dietary supplements used as male enhancement products. To date, Health Fixer has not received any reports of 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/health-fixer-issues-voluntary-nationwide-recall-male-ultra-malextra-electro-buzz-ultra-armor-and
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Apr 30, 2025
Issued at HKT 17:45
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