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MHRA issues medicines recall for Pfizer’s Accupro 

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Pfizer has recalled all stocks of Accupro — including 5mg, 10mg, 20mg, 40mg film-coated tablets — as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.

“Following testing, N-nitroso-quinapril, has been observed at a level above the acceptable limit. Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The recall is at pharmacy and wholesaler level,” the Pharmaceutical Services Negotiating Committees (PSNC) reported.

The Department of Health and Social Care (DHSC) said: “All strengths of quinapril (Accupro) tablets have been recalled with a resupply date to be confirmed. Pfizer are the sole supplier of quinapril tablets in the UK. Alternative ACE inhibitors remain available and can support an uplift in demand.”

Accupro 5mg film-coated tablets

Batch Number Expiry Date Pack Size First Distributed
FJ7218 31.05.2024 28 27th October 2021
EY5501 31.12.2022 28 2nd June 2021
EA9306 31.12.2022 28 10th November 2020

Accupro 10mg film-coated tablets

Batch Number Expiry Date Pack Size First Distributed
FK8588 30.06.2024 28 10th November 2021
EP6753 30.06.2023 28 23rd April 2021

Accupro 20mg film-coated tablets

Batch Number Expiry Date Pack Size First Distributed
FF8046 30.04.2024 28 22nd February 2022
FF8045 31.12.2022 28 7th October 2021
EA9304 30.09.2022 28 28th December 2020
DK4190 30.09.2022 28 7th April 2020

Accupro 40mg film-coated tablets

Batch Number Expiry Date Pack Size First Distributed
FK9758 30.04.2024 28 9th December 2021
EP1602 30.09.2022 28 21st April 2021
CW7390 30.09.2022 28 12th February 2020

Advice for healthcare professionals

Pharmacists are advised to quarantine all remaining stock of the specified batches and return them to their supplier using the supplier’s approved process.

Patients should be advised not to stop any treatments without consulting their relevant healthcare professional.

DHSC said: “Based on the available data, there is no immediate risk to patients who have been taking this medication.

“Advise patients undergoing treatment not to discontinue Accupro without consulting with their prescriber, as there are potential risks associated with suddenly stopping treatment for blood pressure. Healthcare professionals should advise patients undergoing treatment to discuss any questions or concerns with their prescribing healthcare professional.”

Additional advice from the Department of Health and Social Care

  • defer initiating any new patients on quinapril (Accupro®) tablets;
  • identify affected patients and refer to local or national treatment guidelines to switch to an alternative ACE inhibitor
  • monitor patients for changes in blood pressure and/or symptom control when prescribing alternative medications; and
  • counsel patients on new medication, dose regime and potential side-effects.

PSNC added: “Pfizer is aware of the current supply constraints related to this product and is working to resolve the issue and resume manufacturing. Further updates relating to potential resupply will be communicated in due course.”

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