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 name
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 |
Active Pharmaceutical Ingredient: Quinapril Hydrochloride
Brief description of the 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 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.
See additional advice from the Department of Health and Social Care
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
- We 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
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. Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
Download documents
Please also see the for further guidance.