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.
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 ...