TOPIC: Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro by Health Fixer: Recall - Due to Undeclared Chloropretadalafil, Propoxyphenylsildenafil and Sildenafil
AUDIENCE: Consumer, Health Care Professional, Pharmacy
ISSUE: HEALTH FIXER is recalling all lots of dietary supplements by the name of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro - because laboratory analysis has found the products to be tainted with chloropretadalafil, propoxyphenylsildenafil, and sildenafil. 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.
Risk Statement: 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.
Health Fixer’s supplements were distributed nationwide across the U.S to Amazon Online Shopping.
To date, HEALTH FIXER has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The tainted capsules are marketed as dietary supplements used as male enhancement products and are used as an oral supplement.
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.
RECOMMENDATIONS:
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Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers that have any Health Fixer dietary supplements which is being recalled should immediately stop using, discard any of the supplements and may contact their doctor in case of any health risk.
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Consumers with questions regarding this recall can contact Health Fixer by the following number (414-888-8818) or e-mail ultrahelpbyfixer@gmail.com.
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