HEALTH FIXER, a company based in Tempe, Arizona, has initiated a voluntary nationwide recall of its dietary supplements Male Ultra, Malextra, Electro Buzz, Ultra Armor, and Male Ultra Pro. These products, sold in blister packs of ten capsules, were found to contain undeclared chemical compounds, specifically chloropretadalafil, propoxyphenylsildenafil, and sildenafil, revealed through laboratory analysis. Sildenafil, a compound approved by the FDA for treating male erectile dysfunction, belongs to a class of drugs called phosphodiesterase (PDE-5) inhibitors. The other two compounds, chloropretadalafil and propoxyphenylsildenafil, are PDE-5 analogues and may pose similar health risks.
A risk statement from the company highlights the potential dangers, stating that consuming products with PDE-5 inhibitors may lead to severe health issues if combined with nitrates, often found in prescription medications for heart-related conditions. Such combinations could result in significant drops in blood pressure, posing life-threatening risks, particularly for individuals with conditions like diabetes, high blood pressure, high cholesterol, or heart disease.
HEALTH FIXER has not received any reports of adverse events related to this recall so far. The supplements, marketed for male enhancement, were available nationwide through Amazon Online Shopping. The company is alerting distributors and consumers about the recall via a press release. Customers in possession of these supplements are advised to stop using and dispose of them, and to consult a doctor if any health risks emerge.
For further inquiries, consumers can contact HEALTH FIXER at (414-888-8818) or via email at ultrahelpbyfixer@gmail.com during business hours from Monday to Friday, 9 a.m. to 6 p.m. Mountain time. Health issues or reactions possibly linked to these supplements should be reported to healthcare providers or the FDA's MedWatch Adverse Event Reporting program.
Users can report issues online at www.fda.gov/medwatch/report.htm, or by submitting forms available at www.fda.gov/MedWatch/getforms.htm, requesting via phone at 1-800-332-1088, and sending completed forms to the pre-addressed location or by fax to 1-800-FDA-0178.
