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You are here: Industry Insights > N-nitroso-varenicline

News List

Pfizer Expands its Voluntary Recall of Chantix americanpharmaceuticalreview
July 21, 2021
Pfizer expanded its voluntary recall of varenicline (Chantix) to 12 consumer-level lots. Pfizer is recalling these lots due to the presence of N-nitroso-varenicline above the company’s acceptable limit for this impurity.
FDA Update on Chantix with Nitrosamine Impurity americanpharmaceuticalreview
July 20, 2021
To ensure patient access to Chantix (varenicline), the FDA will not object to certain manufacturers temporarily distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the ...