AEMPS Issues Health Alerts Over Medical Devices, Cosmetics, and Mislabeled Supplements
The Spanish Agency of Medicines and Medical Devices has issued safety recalls for Medtrum diabetes sensors, specific Yodeyma children's fragrances, and a mislabeled supplement containing sildenafil.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued several health alerts this week, highlighting safety and quality concerns across three categories: medical devices, children's cosmetics, and mislabeled food supplements.
Medical Devices The AEMPS has ordered a precautionary recall of MD3658 sensors and MD1158 transmitters, which are part of the Medtrum A8 TouchCare System. This follows reports of technical issues discovered during testing in Portugal. While distribution in Spain appears to have been limited to a single center in Tenerife, authorities are investigating whether the products have spread further. The recall does not affect the system’s insulin pump or diabetes manager, and no injuries have been reported in Spain.
Children’s Cosmetics Several batches of "Yodeyma Kids" fragrance are being recalled because they contain benzyl alcohol at levels exceeding the 0.001% limit. Under European regulations, this allergen must be clearly stated on the label to protect children who may be sensitive to it. The recall affects 15ml, 50ml, and 125ml bottles with reference numbers ranging from EY26KID to EY34KID, Y515KID, Y516KID, and PY29KID to PY31KID.
Food Supplements The AEMPS has banned the sale of a product marketed as "Bichota." An investigation by the Judicial Police found that this supposed food supplement actually contains sildenafil, a drug used to treat erectile dysfunction. Because the product is not authorized as a medication, it poses a serious health risk. Sildenafil can be dangerous for people with heart conditions, liver issues, or certain eye disorders, and it can cause severe reactions when mixed with other medications.