Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX


(WEHT)– Pfizer is recalling an additional four lots of Chantix 0.5mg/1 mg Tablets due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level which is a possible carcinogen.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but the company says there is no immediate risk to patients taking this medication which is used to help people quit smoking and is intended for short term use.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. 

Pfizer says patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

The product lots affected were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from June 2019 to June 2021.

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