- U.S. Food and Drug Administration (FDA) (http://dev-voice.ons.org/topic/us-food-and-drug-administration-fda)
- Oncology Drug Research (http://dev-voice.ons.org/topic/oncology-drug-research)
- Patient Safety (http://dev-voice.ons.org/topic/patient-safety)
- Clinical Practice (http://dev-voice.ons.org/topic/clinical-practice)
FDA Expands Recall to Include Four Additional Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-four-additional-lots-chantixr-varenicline-tablets) Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported (https://voice.ons.org/news-and-views/fda-announces-recall-for-12-lots-of-varenicline-tablets-because-of-n-nitroso) Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.
Long-term ingestion of N-nitroso-varenicline has a theoretical potential to increase cancer risk in humans, but FDA reported no immediate risk to patients taking the medication. FDA added that the health benefits of smoking cessation outweigh the theoretical potential cancer risk from the nitrosamine impurities in varenicline.
The product lots were distributed nationwide to wholesalers and distributors in the contiguous United States and Puerto Rico from June 2019–June 2021. The national drug code (NDC), lot number, expiration date, and configuration details for varenicline tablets are shown in the following table:
|
Product |
NDC |
Lot Number |
Expiration Date |
Presentation |
Configuration/Count |
|
Varenicline tablets, 0.5 mg |
0069-0468-56 |
00019213 |
2022 JAN |
Bottles |
56 tablets per bottle |
|
Varenicline tablets, 0.5 mg |
0069-0468-56 |
EC6994 |
2023 MAY
|
Bottles |
56 tablets per bottle |
|
Varenicline tablets, 1 mg |
0069-0469-56 |
EA6080 |
2023 MAR |
Bottles |
56 tablets per bottle |
|
Varenicline tablets, 1 mg |
0069-0469-56 |
EC9843 |
2023 MAR |
Bottles |
56 tablets per bottle |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00018522 |
2021 AUG |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00018523 |
2021 AUG |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00018739
|
2021 AUG |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00018740
|
2021 AUG |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00020231 |
2021 SEP |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00020232 |
2021 NOV |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00020357 |
2021 DEC
|
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00020358 |
2022 JAN |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
00020716 |
2022 JAN |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
ET1600
|
2023 JAN |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03
|
ET1607
|
2023 JAN
|
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
|
Varenicline tablets, 0.5/1 mg |
0069-0471-03 |
ET1609 |
2023 JAN |
Cartons containing two blister packs |
Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug |
Patients taking varenicline tablets should consult their healthcare provider or pharmacy to determine if they have the affected product lots. Patients with the affected lots should contact Stericycle at 888-276-6166, Monday–Friday, from 8 am–5 pm (ET).
Healthcare professionals with questions regarding the recall can contact Pfizer medical information at 800-438-1985, option 3, Monday–Friday, from 9 am–5 pm (ET). Healthcare professionals can report adverse events and product issues at 800-438-1985.
Healthcare professionals and consumer should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using this product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.