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Public Alert No. 044/2021 – Alert on Pfizer’s Expanded Recall of Four Additional lots of Chantix (Varenicline) Tablets, Due to the Presence of Nitrosamine, N-Nitroso-Varenicline above Pfizer Established Acceptable Daily Intake (ADI) Level

December 6, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC)  has received information from US FDA that Pfizer is voluntarily recalling four (4) additional lots of Chantix (Varenicline) Tablets following the recall of twelve (12) lots in July. The recall is due to the presence of Nitrosamine, N-nitroso-varenicline above Pfizer established acceptable daily intake (ADI) level.

Chantix is an FDA approved smoking cessation treatment to help patients quit smoking and is intended for short-term use. Pfizer said it discovered N-nitroso-varenicline, a type of organic compound called a nitrosamine, in the product at levels higher than the company’s acceptable intake limit.

Nitrosamine can occur naturally in certain foods such as cheeses, grilled meats, vegetables, and in water and cosmetics. However, long term exposure to high levels of N-nitroso-varenicline can increase the risk of cancer.

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, according to a release from Pfizer.

Product details: The details of the affected lots are as follows;

Product NDC Lot Number Expiration Date Presentation Configuration/Count
Chantix
(varenicline) Tablets, 0.5 mg
0069-0468-56 00019213 2022 JAN Bottles 56 tablets/bottle
Chantix
(varenicline) Tablets, 0.5 mg
0069-0468-56 EC6994 2023 MAY Bottles 56 tablets/bottle
Chantix
(varenicline) Tablets, 1 mg
0069-0469-56 EA6080 2023 MAR Bottles 56 tablets/bottle
Chantix
(varenicline) Tablets, 1 mg
0069-0469-56 EC9843 2023 MAR Bottles 56 tablets/bottle
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00018522 2021 AUG Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00018523 2021 AUG Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00018739 2021 AUG Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00018740 2021 AUG Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00020231 2021 SEP Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00020232 2021 NOV Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00020357 2021 DEC Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00020358 2022 JAN Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 00020716 2022 JAN Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 ET1600 01/2023 Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 ET1607 01/2023 Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets
Chantix (varenicline) Tablets, 0.5/1 mg 0069-0471-03 ET1609 01/2023 Cartons containing 2 blister packs Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg
tablets

NAFDAC implores importers, distributors, retailers, and consumers to stop the importation, distribution, sale and use of the affected lots of Chantix (Varenicline) Tablets.

Members of the public in possession of the recalled lots are implored to discontinue sale or use, and hand over stock to the nearest NAFDAC office.

NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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