MHRA Class 2 Medicines Recall: Accuretic 10/12.5 mg film-coated tablets (Pfizer Limited)

Class 2 Medicines recall: Accuretic 10/12.5 mg film-coated tablets (Pfizer Limited)

Drug alert number: EL (22) A/16

Date issued: 28th March 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: Accuretic 10/12.5 mg film-coated tablets (Pfizer Limited) PL 00057/0518

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.

Batch Number Expiry Date Pack Size First Distributed
DD4842 31-10-2022 28 6th April 2020

Active Pharmaceutical Ingredient: Quinapril Hydrochloride and Hydrochlorothiazide

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.

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.

Full drug alert can be viewed here.