FDA MedWatch - Twelve Lots of CHANTIX (Varenicline) Tablets by Pfizer:

Recall - Due to N-Nitroso Varenicline Content

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Twelve Lots of CHANTIX (Varenicline) Tablets by Pfizer: Recall - Due to N-Nitroso Varenicline Content AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Pfizer is 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 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. To date, Pfizer has not received any reports of adverse events that have been related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Chantix is a treatment to help patients quit smoking and is intended for short term use.  RECOMMENDATIONS:  Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options. Wholesalers and distributors with an existing inventory of the lots, should stop use and distribution and quarantine the product immediately. If you have any of the affected product lots in your inventory, follow the instructions for returning the product.  Patients with dispensed affected lots in their possession are requested to return product and follow instructions. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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