americanpharmaceuticalreviewJuly 21, 2021
Tag: Pfizer , Chantix , N-nitroso-varenicline
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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