Class 2

Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets, EL(22)A/21

Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure

MDR Number: MDR 009-03/22

Company name: Pfizer Limited

Product description and details of affected batches:

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

Brief description of problem:

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.

Advice to 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.

All healthcare professionals in primary and secondary care should:

  • 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.

Advice to patients:

  • The MHRA have asked pharmacists to stop supplying Accupro® tablets after they were found to have excess levels of a chemical impurity that may potentially increase the risk of cancers if taken for a long time
  • Do not stop taking tablets for blood pressure without talking to your prescriber as there are potential risks associated with suddenly stopping treatment for blood pressure. Based on the available data, there is no immediate risk to patients who have been taking this medication.
  • Your prescriber will review your blood pressure treatment and switch you from Accupro to a suitable alternative

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.

To access the full recall: Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets, EL(22)A/21

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