MHRA recalls 3 batches of Irbesartan over contamination concerns

In 2018 an investigation found that N-nitrosodimethylamine (NDMA), which is thought to have carcinogenic potential, was introduced in the manufacturing process of a valsartan drug in a Chinese facility. Now the Medicines and Healthcare Products Regulatory Agency has recalled three batches of heart and blood pressure medication Irbesartan over the potential contamination of sartan-containing medicines with N nitrosodiethylamine (NDEA), also thought to have carcinogenic potential, and follows two recalls in January. There is however no evidence that NDEA contamination is harmful to patients, and they are advised to continue taking their medication.
MHRA’s Director of the Inspection, Enforcement and Standards Division, Dr Sam Atkinson, said: “Patient safety is our top priority and we will take any necessary steps to protect public health. Today’s Irbesartan recall shows we are continuing to investigate potential contamination of sartan containing medicines. There is no evidence at present that medicines containing NDMA or NDEA have caused any harm to patients the recall is occurring as a precaution. Because of the risk associated with suddenly stopping high blood pressure medication, continue to take your medicines as prescribed by your doctor. Please speak to your doctor or pharmacist if you have any concerns about your medicine.”