Medicine recalls
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| The United States: Pfizer voluntary nationwide recall of lots of Accuretic (quinapril HCl／hydrochlorothiazide), quinapril and hydrochlorothiazide tablets, and quinapril HCl／hydrochlorothiazide tablets due to N-nitroso-quinapril content |
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The US Food and Drug Administration (FDA) announces that Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level. The affected products are:
- Accuretic (quinapril HCl/hydrochlorothiazide) tablets 10/12.5 mg (lot number: FG5379, EA6686)
- Accuretic (quinapril HCl/hydrochlorothiazide) tablets 20/12.5 mg (lot number: FG5381, EA6665, CN0640)
- Accuretic (quinapril HCl/hydrochlorothiazide) tablets 20/25 mg (lot number: ET6974)
- quinapril and hydrochlorothiazide tablets 20/25 mg (lot number: FE3714)
- quinapril HCl/hydrochlorothiazide tablets 20/12.5 mg (lot number: DN6931, ED3904, ED3905)
- quinapril HCl/hydrochlorothiazide tablets 20/25 mg (lot number: DP3414)
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 4 Mar 2022.
Ends/Wednesday, Mar 23, 2022
Issued at HKT 15:30
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