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

U.S. Food and Drug Administration sent this bulletin at 09/17/2021 01:15 PM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: All Lots of CHANTIX (Varenicline) Tablets by Pfizer: Recall Expansion - Due to N-Nitroso Varenicline Content

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy

ISSUE: Pfizer is recalling all lots of Chantix 0.5 mg and 1 mg tablets due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit.

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 reports of adverse events assessed to be 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:

Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options. Patients with Chantix Tablets should contact Stericycle for instructions on how to return their product and obtain reimbursement for their cost.

Health Professionals:

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately. If you have any of the product in inventory, please follow the instructions above for returning the product to Stericycle.
If you are aware of any patients to whom you dispensed the products and who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Stericycle.

Wholesalers and Distributors:

Wholesalers and distributors with an existing inventory of Chantix tablets should stop use and distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Request they immediately cease distribution of the product and promptly contact Stericycle.

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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