NEW YORK — Pfizer Inc. has recalled its anti-smoking drug, Chantix, citing high concentrations of an ingredient linked to increased cancer risk.
In a notice posted to the U.S. Food and Drug Administration’s website on Thursday, Pfizer confirmed that it is recalling Chantix 0.5 mg and 1 mg tablets due to the presence of N-nitroso-varenicline.
The cautionary recall was instigated because long-term ingestion of N-nitroso-varenicline can be associated with a “theoretical potential increased cancer risk in humans,” the notice stated.
The pharmaceutical giant also noted in its recall notice that there is no immediate risk to patients taking the drug and reiterated its stance that the health benefits of stopping smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”
Specifically, the recall affects all lots of the drug distributed to wholesalers and distributors nationwide, as well as in the U.S. Virgin Islands and Puerto Rico, from May 2019 to September 2021.
“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the New York-based company stated.
In a Friday update, the FDA advised patients to continue taking their prescribed medicine until their pharmacists provide a replacement or their doctors prescribe a different treatment.
According to The Hill, Pfizer previously recalled 12 lots of Chantix in July due to the presence of N-nitroso-varenicline. It then recalled four additional lots in August due to the impurity.
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