BRIEF—Pfizer in voluntary recall of Chantix lots

US pharma giant Pfizer is voluntarily recalling all lots of Chantix 0.5mg and 1mg tablets (varenicline), a medication used to help people stop smoking.

This is due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the US Food and Drug Administration (FDA) interim acceptable intake limit.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in people, the FDA has said. But the agency has confirmed that there is no immediate risk to patients taking this medication and states that the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

As alternative suppliers have been approved in the USA, Pfizer is undertaking this precautionary measure.