Irbesartan batches recalled over contamination

Batches of some irbesartan-containing products are being recalled because of contamination with an impurity that has mutagenic potential.

No shortages of irbesartan-containing products are expected as a result of the recall. | GETTY IMAGES
No shortages of irbesartan-containing products are expected as a result of the recall. | GETTY IMAGES

Specific batches of Aprovel (irbesartan), CoAprovel (irbesartan/hydrochlorothiazide) and irbesartan Zentiva are being recalled 'as a precautionary measure' following detection of a potentially mutagenic impurity called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole.

Healthcare professionals should immediately stop supplying the batches listed in the medicines recall, quarantine all remaining stock and return it to the supplier.

Patients are advised not to stop taking their medication prior to consultation with their doctor or pharmacist, as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity. 

There are no anticipated shortages of irbesartan-containing products in the UK as a result of this recall. However, the MHRA says the situation is 'a developing issue' and it is working with marketing authorisation holders and other medicines regulators to determine any possible impact. An investigation into other potentially affected products is continuing and further updates will be provided as the investigation progresses.

MIMS encourages healthcare professionals who do experience any difficulties obtaining irbesartan to complete the pop-up box at the bottom of the MIMS drug shortages tracker or email mimsinfo@haymarket.com.

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