This drug is used to control hypertension.
The Spanish Agency for Medicines and Health Products (Aemps) of the Ministry of Health issued a withdrawal alert, due to impurities above its accepted limit, of six batches in different presentations of Irbesartan Combix, a medicine for the control of hypertension.
Specifically, these are two batches (M000689 with expiration date 03/31/2023 and M012157 with expiration date 11/30/2023) of Irbesartan Combix 300 mg; two lots (M010064 with expiration date 07/31/2023 and M100406 with expiration date 01/31/2024) of Irbesartan Combix 75 mg; lot M011549 with expiration date 08/31/2022 of irbesartan/hydrochlorothiazide combix 150 mg/12.5 mg; and lot M015999 with expiration date 11/30/2022 of irbesartan/hydrochlorothiazide pharma combix 300 mg/25 mg.
The AEMPS requested the withdrawal from the market of all the distributed units of the affected batches and their return to the laboratory through the usual channels; and to the Autonomous Communities that monitor the withdrawal.