Public Alert No. 28/2021 – Alert on Recall of Chantix (Varenicline) Tablets by Pfizer, Due to the Presence of Nitrosamine, N-Nitroso-Varenicline above Pfizer Established Acceptable Daily Intake (ADI) Level.
August 10, 2021,
The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from US FDA that Pfizer is voluntarily recalling twelve (12) lots of Chantix (Verencline) Tablets – two 0.5 mg tablet lots, two 1.0 mg tablet lots, and eight lots of a Chantix kit that includes both 0.5 mg and 1.0 mg doses. 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.
The FDA maintains that the health benefits of quitting smoking outweigh the potential cancer risk from the presence of nitrosamine in varenicline, as there is no immediate risk to patients taking Chantix.
To date, Pfizer has not received any reports of adverse events that have been related to this recall.
|S/No.||ITEM||LOT No.||EXP. DATE|
|1||0.5 mg tablets, 56-count bottles||00019213||Jan 2022|
|2||0.5 mg tablets, 56-count bottles||EC6994||May 2023|
|3||1.0 mg tablets, 56-count bottles||EA6080||Mar 2023|
|4||1.0 mg tablets, 56-count bottles||EC9843||Mar 2023|
|5||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||00020231||Sep 2021|
|6||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||00020232||Nov 2021|
|7||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||00020357||Dec 2021|
|8||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||00020358||Jan 2022|
|9||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||00020716||Jan 2022|
|10||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||ET1600||Jan 2023|
|11||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||ET1607||Jan 2023|
|12||Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets||1609||Jan 2023|
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 firstname.lastname@example.org or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng