MHRA Class 2 Medicines Recall: Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets (Pfizer Limited)

MHRA Class 2 Medicines Recall: Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets (Pfizer Limited)

May 5, 2022

Class 2 Medicines recall: Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets (Pfizer Limited)

Drug alert number: EL (22) A/21

Date issued: 5th May 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets (Pfizer Limited)

Pfizer Ltd are voluntarily recalling all stock of the above product 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.

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

Please quarantine all remaining stock of the specified batches and return them to your supplier using your supplier’s approved process.

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

Please also see the Direct Healthcare Professional Letter for further guidance.

Full drug alert can be viewed here.

Company contacts for further information

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. If you have any questions, then please contact your local Service Centre Customer Services team.

For medical information enquiries, please contact Pfizer Medical Information Department on 01304 616161.



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