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MHRA recalls some products containing irbesartan


MHRA recalls some products containing irbesartan

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall of some products containing irbesartan amid fears of possible contamination.

The regulator recalled the products, made by Actavis (now Accord), as a precaution because of concerns over N‑nitrosodiethylamine (NDEA) contamination.

The MHRA said there was no evidence that patients have suffered harm as a result of possible contamination and stressed that not all irbesartan products have been affected.

The MHRA urged anyone with concerns to talk to their doctor or pharmacist but not stop taking their medication. It also urged pharmacists to quarantine any affected batches.

“Our highest priority is making sure the medicines you take are safe. Our investigation into potential contamination of sartan-containing medicines, including irbesartan, is ongoing,” said Dr Sam Atkinson, the MHRA’s director of the inspection, enforcement and standards division.

“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.”

In July last year the MHRA advised pharmacies to recall affected batches of valsartan-containing medicines made by Teva and Mylan as a precaution.

In November pharmacies were advised to recall batches of valsartan from Dexcel and Actavis as a precaution.


Picture: LPETTET (iStock)

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