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MHRA recalls further 25 batches of contaminated irbesartan-containing medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken the "precautionary measure" of issuing a pharmacy/wholesaler level recall for a further 25 batches of irbesartan-containing medicines.

The 25 batches are contaminated with an impurity that “could potentially increase the risk of cancer over time”, but there is no evidence to suggest this impurity has caused any harm to patients, the MHRA said in a statement today (August 9).

The medicines watchdog pointed to when it recalled similar products in 20182019 and June 2021, as part of an "ongoing investigation". It is working with other regulators on this issue, it said.

MHRA chief safety officer Dr Alison Cave said: “Patient safety is at the heart of what we do. We’re recalling batches of certain irbesartan-containing products as a precautionary measure while we continue our investigation.”

 

Check stock and quarantine batches

 

Pharmacists should stop supplying the affected batches immediately, quarantine all remaining stock and return it to their supplier, the MHRA said.

They should also advise patients on taking their irbesartan-containing medication. The MHRA said patients should not stop taking these without consulting a healthcare professional “as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity”.

The medicines regulator does not expect this recall will trigger shortages of irbesartan-containing products in the UK. However, this is a “developing issue”, it said.

Find full list of affected batches recalled by the MHRA today here

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