The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Healthhas ordered the withdrawal of a batch of the statin Simvastatin Cinfa 40 mg film-coated tablets EFG for having a “box version and unauthorized prospects“.
Specific, the affected batch is BT1432, with an expiration date of June 30, 2023, from the Cinfa laboratory. Faced with this situation, the AEMPS has ordered the “withdrawal from the market of all the distributed units of the affected batches and their return to the laboratory through the usual channels”.
this drug contains the active substance simvastatin, which is used to reduce the levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides that circulate in the blood. In addition, it raises the concentrations of “good” cholesterol (HDL cholesterol).