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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.

Product details

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 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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