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Pfizer Expands its Voluntary Recall of Chantix

americanpharmaceuticalreviewJuly 21, 2021

Tag: Pfizer , Chantix , N-nitroso-varenicline

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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 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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