Pfizer has announced a recall of varenicline, the anti-smoking drug sold under the brand name Chantix, for the second time in two weeks. Both recalls, the latest on Friday, concern the presence of N-nitroso-varenicline.
Pfizer says these lots have more than the company’s, not the FDA’s, acceptable daily Intake 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,” says the Pfizer-written, FDA-posted recall notice. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”
The Chantix recalled on July 2 was sitting in wholesaler and distributor warehouses. This recall goes to the consumer level, meaning you or your pharmacist could have it already.
What Chantix is recalled?
- 0.5 mg tablets, 56-count bottles, lot No. 00019213, expiration 2022 JAN and lot No. EC6994, expiration 2023 MAY.
- 1.0 mg tablets, 56-count bottles, lot No. EA6080 and EC9843, both expiration 2023 MAR.
- Blister packs of 11 0.5 mg tablets and 42 1.0 mg tablets, lot No. 00020231, expiration 2021 SEP; lot No. 00020232, expiration 2021 NOV; lot No. 00020357, 2021 DEC; lot Nos. 00020358 and 00020716, expiration 2022 JAN; lot Nos. ET1600, ET1607 and 1609, expiration 01/2023.
Is there an immediate risk of cancer?
No. Continued consumption over time can increase the risk of getting cancer. Keep taking it until you work with your doctor or pharmacist to come up with another treatment.
What should you do if you have a recalled lot?
If you’re a wholesaler or distributor, quarantine what you have and notify your customers of the recall. Wholesalers, distributors or retail sellers should contact Stericycle at 888-276-6166, Monday through Friday, 8 a.m. to 5 p.m., Eastern time for a business reply card to start the return process.
Consumers also should call Stericycle at the above number for return instructions and refund information.
Those who received free Chantix through Pfizers Patient Assistance Program or the Pfizer Institutional Patient Assistance Program, should call Stericycle to return the tablets. To request replacements, call 833-203-2776, Monday through Friday, 8 a.m. to 6 p.m., Eastern time.
What to do if this drug causes a medical problem?
After notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
Only then do you call Pfizer at 800-438-1985, option 1, 24 hours a day, seven days a week.