Pfizer is expanding its voluntary recall of Chantix® (varenicline) 0.5mg and 1mg tablets to include all lots due to the presence of a nitrosamine impurity above the Food and Drug Administration (FDA)’s acceptable daily intake limit. 

Long-term use of a product containing N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.

The recalled lots of Chantix were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from May 2019 to September 2021. The full list of recalled products can be found here. 

In July 2021, the FDA announced that it would permit varenicline tablets containing N-nitroso-varenicline up to the interim acceptable intake limit of 185ng per day to be distributed in the US in order to maintain an adequate supply of the smoking cessation therapy in the country. To mitigate a potential shortage, temporary distribution of Apo-Varenicline, a varenicline product distributed by Apotex Inc. in Canada, will be allowed in the US.


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Adverse events associated with these products should be reported to the FDA’s MedWatch Program.

References

  1. FDA updates and press announcements on nitrosamine in varenicline (Chantix). News release. US Food and Drug Administration. Accessed September 17, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix. 
  2. Pfizer expands voluntary nationwide recall to include all lots of Chantix® (varenicline) tablets due to N-nitroso varenicline. News release. Pfizer. September 16, 2021. Accessed September 17, 2021. https://cdn.pfizer.com/pfizercom/2021-09/Press-Release-Chantix-All-Lots-16SEP21.pdf?JTi.179qjytJBu2MVYPYt.dWuN8ic5Vx.

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