Pfizer has expanded its voluntary recall of smoking cessation drug Chantix, according to an update posted on the US Food and Drug Administration (FDA) website.
On July 2, the FDA alerted patients and healthcare professionals of Pfizer’s voluntary recall of nine lots of varenicline because of the possibility that the tablets may contain a nitrosamine impurity, N-nitroso-varenicline, at a level higher than the agency’s acceptable intake limit.
Pfizer has now added three more lots to the recall.
In its latest update, the FDA once again states, “the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.”
“N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the FDA said, as reported earlier this week by Medscape Medical News.