Medicine recalls
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| The United States: Lupin Pharmaceuticals, Inc. issues voluntary nationwide recall of four lots of Quinapril Tablets due to potential presence of N-nitroso-quinapril impurity |
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The US Food and Drug Administration (FDA) announces that Lupin Pharmaceuticals, Inc. is voluntarily recalling four lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-nitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. The affected products are:
- Quinapril Tablets USP, 20mg (lot number: G102929)
- Quinapril Tablets USP, 40mg (lot number: G100533, G100534, G203071)
To date, Lupin has received no reports of illness that appear to relate to this issue. Lupin discontinued the marketing of Quinapril Tablets in Sep 2022.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-four-lots-quinapril-tablets-due
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 4 Mar 2022, with the latest update posted on 9 Dec 2022.
Ends/Thursday, Dec 22, 2022
Issued at HKT 14:00
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