Pfizer Issues Nationwide Recall Notice

Summary

Company Announcement Date:
August 16, 2021
FDA Publish Date:
August 16, 2021
Product Type:
Drugs
Reason for Announcement:
N-Nitroso Varenicline content above acceptable daily intake level
Company Name:
Pfizer
Brand Name:
CHANTIX
Product Description:
Smoking cessation treatment

Company Announcement

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

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. i

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. ii Smoking is also associated with many other cancers.iii CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets is indicated in the table below with the four additional lots. Photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.

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

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Read the full report here.

As published on Healthyexaminer.com.