(WTAJ) — Pfizer voluntarily recalled all batches of Chantix 0.5 mg and 1 mg tablets at the patient and consumer level due to the presence of an amount of nitrosamine above the Food and Drug Administration (FDA) acceptable limit.
The recall comes two months after Pfizer paused distribution of the drug in July and pulled nine lots from production and shelves. Pfizer has notified wholesalers and distributors with an existing inventory to stop distribution and production immediately.
There is no immediate risk to patients currently taking Chantix, according to the FDA. However, patients taking the medication should consult with their health care provider to determine if alternative treatments are available.
The affected lots were distributed nationwide to distributors and wholesalers nationwide from May 2019 to September 2021.
N-Nitroso-varenicline belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests such as rodent carcinogenicity studies.
Although there are no data available to directly evaluate the carcinogenic potential of N-nitroso-varenicline, information available on closely related nitrosamine compounds were used to calculate lifetime exposure limits.
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