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.
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To date, the Company has not received any reports of adverse events related to this recall.
N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.
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.