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Pfizer expands recall of 4 additional lots of varenicline tablets

Pfizer announced a voluntary recall of another 4 lots of varenicline (Chantix) 0.5 mg/1 mg tablets to the consumer level due to the presence of a nitrosamine, N-nitroso-varenicline, above the established acceptable daily intake level.

“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the company said in a news release. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

Pfizer noted that patients currently using varenicline should speak with their health care provider to determine whether they received an affected lot, and if appropriate, discuss alternative treatment options.

Pfizer has received no reports of adverse events related to this recall. The product lots were distributed nationwide to wholesalers and distributors from June 2019 to June 2021. Pfizer previously announced a voluntary nationwide recall of 12 lots of varenicline due to N-nitroso-varenicline in July.

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