MHRA recalls 44 batches of irbesartan due to chemical substance
Fourty-four batches of irbesartan-containing medicines have been recalled from pharmacies and wholesalers by the MHRA as a precautionary measure.
The medicines watchdog announced today that batch testing had detected the presence of a chemical substance (AZBT) over the limit permitted for these medicines. The batch numbers being recalled are listed in full on the Class 2 recall notice.
Lab testing has found that long-term exposure to AZBT above certain limits may increase an individual’s risk of developing cancer, but there is no evidence that any patients have come to harm as a result of being exposed.
While pharmacies and wholesalers are being told to stop supplying the affected batches immediately and quarantine remaining stock before returning it to their suppliers, patients are advised to keep taking their medicine as the risk of discontinuing it is greater than the potential risk posed by the impurity.
MHRA chief safety officer Alison Cave said: “This recall is a precautionary measure to prevent further exposure to AZBT above the acceptable safety limit. There is no evidence that this substance has caused any harm to patients.
“It’s vitally important that you continue to take your medicine but do contact your doctor or pharmacist if you have any questions.
“It’s important that healthcare professionals check their stock to quarantine and return these batches to their supplier using their supplier’s approved process.
“The MHRA has asked companies to implement control measures to ensure that the levels of the substance are at or below the required level. We are also working with our international counterparts, given this is a global issue, to ensure the safety of patients.”