Blood pressure drug recalled due to excessive impurities

The Spanish Ministry of Health has recalled six batches of a drug commonly used to control blood pressure, due to the presence of excessive impurities.
The Spanish Agency of Medicines and Health Devices (Aemps), an institution dependent on the Ministry of Health, has ordered six batches of irbesartan to be recalled from the market due to the detection of impurities that exceed the acceptable limit. Irbesartan is a medication used to control blood pressure.
The products to be recalled are Irbesartan Combix 300 mg (batches M000689, with expiry date 31/03/2023, and M012157, with expiry date 30/11/2023); Irbesartan Combix 75 mg (batches M010064, with expiry date 31/07/2023, and M100406, with expiry date 31/01/2024); Irbesartan/Hydrochlorothiazide Combix 150 mg (batch M011549, with expiry date 31/08/2022) and Irbesartan/Hydrochlorothiazide Pharma Combix 300 mg (batch M015999, with expiry date 30/11/2022).
The Aemps has ordered all products from the affected batches to be withdrawn from the market and returned to the laboratory (Combix) due to the “detection of an impurity greater than the accepted limit in the active ingredient irbesartan”. The autonomous communities are to monitor the withdrawal.
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