Pfizer recalls batches of Accupro over potential safety risk

Health & NHS

Pfizer recalls batches of Accupro over potential safety risk

Pfizer has recalled batches of Accupro 5mg, 10mg, 20mg and 40mg film-coated tablets after they were found to contain potentially dangerous levels of an organic compound that could cause cancer.

The Medicines and Healthcare products Regulatory Agency said tests revealed N-nitroso-quinapril was “observed at a level above the acceptable limit.” The regulator advised pharmacists and other healthcare professionals to quarantine all remaining stock of the affected batches and return them to their supplier.

The affected 5mg batches are FJ7218, EY5501 and EA9306, the 10mg batches are FK8588 and EP6753, the 20mg batches are FF8046, FF8045, EA9304 and DK4190 and the 40mg batches are FK9758, EP1602 and CW7390.

The MHRA said there was “no immediate risk” to patients taking the medication and urged anyone undergoing treatment not to stop taking Accupro without consulting their prescriber because of the risks “associated with suddenly stopping treatment for blood pressure.”

The MHRA also urged healthcare professionals to defer putting any new patients on quinapril (Accupro) tablets, refer affected patients to local or national treatment guidelines and switch to an alternative ACE inhibitor, watch for any changes in their blood pressure when prescribing alternative medications and talk to anyone who starts a new medication about the dose and potential side-effects.

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