The medicines watchdog has recalled certain batches of products containing ibesartan made by the manufacturer Accord (formerly Actavis) over contamination fears.
The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday (3 January) recalled the products as a ‘precautionary measure’ following possible N‑nitrosodiethylamine (NDEA) contamination.
There is currently no evidence that the potential contamination has caused any harm to patients and not all irbesartan products are affected, it stressed.
You can see the affected batched by clicking this link.
The recall follows a Europe-wide investigation into the contamination of sartan products, the watchdog said.
Some products were recalled ‘after an impurity, N-nitrosodimethylamine (NDMA), was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China. A second impurity, NDEA, was later discovered,’ it added.
The MHRA said it is ‘working closely’ with other EU member states, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to ‘ensure a thorough investigation’.
Consult pharmacist before stopping treatment
MHRA director of the inspection, enforcement and standards division Dr Sam Atkinson said: ‘Our investigation into potential contamination of sartan containing medicines, including irbesartan, is ongoing.
‘At present, there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients.
‘Because of the risk associated with suddenly stopping high blood pressure medication, people are advised not to stop any treatments without consulting their doctor or pharmacist.’