Class 2 Medicines Recall: Pfizer Limited, Accuretic 10/12.5 mg film-coated tablets, EL (22)A/16

Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.

MDR Number: MDR 009-03/22

Company name: Pfizer Limited

Product description: Accuretic 10/12.5 mg film-coated tablets, PL 00057/0518

Details of the affected batch:

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. The risks of suddenly stopping medication for blood pressure is higher than the potential risk presented by the impurity. Healthcare professionals should advise patients undergoing treatment to discuss any questions or concerns with their prescribing healthcare professional.

Company contacts for further information:

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, Accuretic 10/12.5 mg film-coated tablets, EL (22)A/16