Medicine recalls
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| The United States: Pfizer issues a voluntary nationwide recall for twelve lots of Chantix (varenicline) Tablets due to N-nitroso-varenicline content |
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The US Food and Drug Administration (FDA) announces that Pfizer is voluntarily recalling two lots of Chantix 0.5 mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5 mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. The affected products are:
- Chantix Tablets 0.5 mg (lot number: 00019213, EC6994)
- Chantix Tablets 1 mg (lot number: EA6080, EC9843)
- Chantix Tablets 0.5 mg/1 mg (lot number: 00020231, 00020232, 00020357, 00020358, 00020716, ET1600, ET1607, ET1609)
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
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.
Pfizer believes the benefit/risk profile of Chantix remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso
In Hong Kong, Champix Tab 0.5mg (HK-55479), Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437) are registered pharmaceutical products containing varenicline. All products are registered by Pfizer Corporation Hong Kong Limited (Pfizer), and are prescription-only medicines. As confirmed with Pfizer, the affected lots have not been imported into Hong Kong. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Jun 2021, with the latest update posted on 3 Jul 2021.
Ends/Tuesday, Jul 20, 2021
Issued at HKT 14:00
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