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AEMPS recalls El Toro due to undeclared sildenafil
The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the immediate market withdrawal and cessation of sales for the product ‘El Toro’. Although marketed as a natural supplement, laboratory analysis by the Official Medicines Control Laboratory (LOCM) confirmed the presence of sildenafil, an active pharmaceutical ingredient used to treat erectile dysfunction.
Because sildenafil is present in quantities sufficient to exert a pharmacological effect, the product is legally classified as a medicine. However, this substance was not declared on the product's labeling. The discovery was made following information provided by the Asturias Superior Police Headquarters.
Health authorities warn that consuming the product poses significant risks, as users are unaware of its true composition. Sildenafil is contraindicated for individuals with certain medical conditions, including acute myocardial infarction, unstable angina, heart failure, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, ischemic stroke, or severe hepatic impairment.
Entities
Agencia Española de Medicamentos y Productos Sanitarios · El Toro · Jefatura Superior de Policía de Asturias · Ministerio de Sanidad