Citing high concentrations of an ingredient linked to increased cancer risk, Pfizer has recalled its popular anti-smoking drug, Chantix.
On Thursday, a notice was posted to the U.S. Food and Drug Administration’s website about the 0.5 mg and 1 mg Chantix tablets being recalled. It was confirmed by the pharmaceutical giant that the presence of N-nitroso-varenicline was in the product.
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The recall is for all lots of the drug distributed to wholesalers and distributors nationwide from May 2019 to September 2021.
While the recall is cautionary, it was instigated because long-term ingestion of N-nitroso-varenicline could be associated with a “theoretical potential increased cancer risk in humans,” the notice said.
Pfizer is also noted in the recall, saying that there is no immediate risk to patients taking the drug. It also shared its stance that the health benefits of not smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”
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“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the company stated.
On Friday, the FDA advised patients to continue taking their medicine that had been prescribed unless their pharmacist provided a replacement or their doctors prescribed a different treatment.
