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| The United Kingdom: Class 2 Medicines Recall: Pfizer Limited, Accuretic 10／12.5 mg film-coated tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pfizer Limited is voluntarily recalling Accuretic 10/12.5 mg film-coated tablets (quinapril hydrochloride/hydrochlorothiazide) (batch number: DD4842) 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-limited-accuretic-10-slash-12-dot-5-mg-film-coated-tablets-el-22-a-slash-16
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada and the United States Food and Drug Administration, and was posted on the Drug Office website on 4 Mar 2022 and 23 Mar 2022.
Ends/Tuesday, Mar 29, 2022
Issued at HKT 14:00
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