Manufacturers can now adequately supply the market with varenicline at or below the acceptable intake limit of 37ng per day.
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To date, the Company has not received any reports of adverse events related to this recall.
Par’s generic version of Chantix is currently the only available one in the US.
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.