Source: MHRA / Gov.uk 23.3.22
Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.
Accuretic 10/12.5 mg film-coated tablets, PL 00057/0518
- Batch number: DD4842
- Expiry date: 30 October 2022
- Pack size: 28
- First distributed: 6 April 2020
Active Pharmaceutical Ingredients: Quinapril Hydrochloride and Hydrochlorothiazide.
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. 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.
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
Please also see the Direct Healthcare Professional Letter below for further guidance that has been sent to prescribers on switching treatment to a suitable alternative:
Click here for the source.