Monday, July 19, 2021

Pfizer Expands its Voluntary Recall of Chantix (varenicline) - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

Pfizer Expands its Voluntary Recall of Chantix (varenicline)

Pfizer expanded its voluntary recall of varenicline (Chantix) to 12 lots to the consumer level. Pfizer is recalling these lots due to the presence of N-nitroso-varenicline above the company's acceptable limit for this impurity. 

FDA reminds patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.

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