THE UK Medicines and Healthcare products Regulatory Agency (MHRA) is recalling certain irbesartan containing products made by Actavis (now Accord) as a precautionary measure, due to possible Nnitrosodiethylamine (NDEA) contamination.
There is no evidence at present that the impurity has caused any harm to patients and not all irbesartan products are affected, the regulatory agency said.
The recall follows a Europe-wide investigation into contamination of sartan products, which during 2018 saw two batches of valsartan containing medicines recalled.
MHRA's Director Sam Atkinson said the investigation into potential contamination of sartan containing medicines, including irbesartan, was ongoing, stressing that at present there was no evidence that medicines containing NDEA or another contaminant, NDMA, had caused any harm to patients.
The above article was sent to subscribers in Pharmacy Daily's issue from 07 Jan 19
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 07 Jan 19
