MHRA recalls Irbesartan contaminated with N-nitrosodiethylamine

19 February 2019

Article: 53/0708

The Scottish Government and the Medicines and Healthcare Products Regulatory Agency (MHRA) have published a drug alert and medicine recall of contaminated Irbesartan, a class of medicine prescribed to treat blood pressure, heart attacks and heart failure.

The recall is taking place as part of the continued investigation into potential N-nitrosodiethylamine (NDEA) contamination of sartan containing medicines. The investigation into possible contamination began in 2018, after another impurity, N-nitrosodimethylamine (NDMA), was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China. NDEA was discovered after further testing.

The MHRA continues to monitor the situation in the UK and are investigating the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM).

Sources: Scottish Government, 13 February 2019 and UK Government, 13 February 2019