MHRA recalls 25 batches of irbesartan medicines

Earlier today the MHRA recalled 25 batches of irbesartan-containing medicines due to concerns they have been contaminated with an impurity that “could potentially increase the risk of cancer over time”.

The recalled lines include severalbatches of Aprovel, manufactured by Aventis, and a generic line made by Zentiva.

The agency stressed that this is a precautionary measure aimed at pharmacies and wholesalers, and that patients should not stop taking any medicine without consulting healthcare professionals. There is no evidence that the impurity (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole) has harmed any patients. 

MHRA chief safety officer Alison Cave said: “Patient safety is at the heart of what we do. We’re recalling batches of certain sartan-containing products as a precautionary measure while we continue our investigation. It’s important that healthcare professionals check their stock to quarantine and return these batches.

“If you’ve been taking one of the affected products, continue to take your medication. Speak with your doctor or pharmacist before stopping any treatment – they can address any concerns and can advise you on the best course of action.

“Previous recalls of these types of products in 2018, 2019 and June 2021 are part of an ongoing investigation. The MHRA is working with other medicines regulators on this issue.”

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