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The United States: FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level (English only)
 
The US Food and Drug Administration (FDA) announces that Pfizer has initiated a voluntary recall of nine lots of the smoking cessation drug, varenicline (brand name Chantix), to the warehouse level. The company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. An increased cancer risk would be associated with long-term use, and the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.

Recalled lots: 00020231, 00020232, 00020357, 00020358, 00020716, 00019213, ET1607, ET1609, EC6994

N-Nitroso-varenicline belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests such as rodent carcinogenicity studies. Although there are no data available to directly evaluate the carcinogenic potential of N-nitroso-varenicline, information available on closely related nitrosamine compounds was used to calculate lifetime exposure limits for N-nitroso-varenicline.
Pfizer is recalling the varenicline lots currently stored in warehouses. FDA recommended Pfizer revise its recall to the consumer level in order to take into account the product currently on the market, but the company has not yet done so.
In addition to the voluntary recall, Pfizer is holding release of varenicline to the U.S. market until it can confirm N-nitroso-varenicline levels below what the company considers to be acceptable.

Please refer to the following website in FDA for details: http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse

In Hong Kong, Champix Tab 0.5mg (HK-55479), Champix Tab 0.5mg & 1mg (HK-55462) and Champix Tab 1mg (HK-55437) are pharmaceutical products 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 Health Canada and Taiwan Food and Drug Administration, and was posted on the Drug Office website on 16 Jun 2021 and 2 July 2021.

Ends/ Saturday, Jul 3, 2021
Issued at HKT 13:15
Content last updated on Monday, Jul 5, 2021

 
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