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Patients who have purchased the affected medication in Spain should return the drug to their local pharmacy
The Spanish Agency for Medicines and Health products (Aemps) has recalled six batches of Irbestan, a drug used to treat blood pressure, due to the detection of an impurity in the medicine. The product is widely available in pharmacies all across Spain.
The following batches have been withdrawn from the market:
- Irbesartan Combix 300 mg (lots M000689 and M012157)
- Irbesartan Combix 75 mg (lots M010064 and M100406)
- Irbesartan/Hydrochlorothiazide Combix 150 mg (lot M011549)
- Irbesartan/Hydrochlorothiazide Pharma Combix 300 mg (lot M015999).
Aemps has ordered that all of the affected medications be returned to the laboratory due to the “detection of an impurity in the active ingredient Irbesartan above its accepted limit". Any patients currently taking this blood pressure treatment should refrain from using it and return the drug to their local pharmacy.
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