The Agencia Española de Medicamentos y Productos Sanitarios (Aemps) has issued an alert concerning Montelukast as several batches are affected.

The medicine/batch nº in question are: Montelukast (brand Cinfa) 4 mg, sold in capsules (batches BS1597, Use By 31/05/2023); Montelukast Cinfa 5 mg (batches BR3131, Use By 31/07/2022). Also batch BS0957, Us By 30/04/2023 and batch BS2137, Use By 31/08/2023).

The reason that they are being withdrawn is because tests have shown that they contain impurities outside the product specifications. Therefore, Aemps requests that they be withdrawn from the market and returned to the Cinfa laboratories.

Aemps classifies products that should be withdrawn because of health problems into three categories; One, being the highest and Three being the lowest. This alert is Category Two.

To quote the NHS Website: Montelukast is used to prevent the symptoms of asthma. It’s usually prescribed when asthma is mild and can stop it from getting worse.

It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

Montelukast is sometimes given to people without asthma to treat hives (urticaria) that last for a long time (more than 6 weeks).

(News: Spain)