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| The United Kingdom: Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pfizer Limited is voluntarily recalling all stock of the following products containing quinapril hydrochloride as a precautionary measure due to the identification of a nitrosamine above the acceptable limit:
- Accupro 5mg film-coated tablets (batch number: FJ7218, EY5501, EA9306)
- Accupro 10mg film-coated tablets (batch number: FK8588, EP6753)
- Accupro 20mg film-coated tablets (batch number: FF8046, FF8045, EA9304, DK4190)
- Accupro 40mg film-coated tablets (batch number: FK9758, EP1602, CW7390)
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. 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-limited-accupro-5mg-10mg-20mg-40mg-film-coated-tablets-el-22-a-slash-21
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 21 Apr 2022, with the latest update posted on 3 May 2022.
Ends/Friday, May 6, 2022
Issued at HKT 15:00
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