Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

If your email program has trouble displaying this email, view as a webpage. Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) 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 health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. 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.

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