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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
