The Spanish Agency for Medicines and Health Products has requested the withdrawal of all the units distributed from the affected batches of Enalapril and their return to the laboratory
Health has withdrawn from circulation a well-known drug to treat high blood pressure. The Spanish Agency for Medicines and Health Products (AEMPS), which reports to this Ministry, has issued an alert about Enalapril, which is used to control high blood pressure and heart failure.
This product has been marketed for more than three decades by the company Alter SA and is manufactured by Toll Manufacturing Services. Now the AEMPS warns that it presents a “out-of-specification result in the evaluation, hardness and related substances tests.” The affected batch is 499R of Enalapril Alter 20 mg EFG tablets, with an expiration date of July 31, 2023.
Health has adopted as a precautionary measure the withdrawal from the market of all distributed units of the affected batches and has urged pharmacies to return them to the laboratory through the usual channels. In this sense, it also requests that the autonomous communities monitor compliance with this measure.
This is the second time that Enalapril has been withdrawn from the market, the last time was in June when the Health Agency issued an alert about possible problems in stability studies in the drug study. The notice affected lot P575 of Enalapril/Hydrochlorothiazide Stada in its presentation of 20/12.5 mg and packs of 28 EFG tablets, with an expiration date of August 31, 2023.