Fourth recall: Chantix from Pfizer for a carcinogenic ingredient

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The four additional batches recalled were presented in Chantix blister packs.

FDA

And now it’s four times for Pfizer – the Chantix recall, that is.

On Thursday, September 16, Pfizer extended its recall of Chantix 0.5 mg and 1 mg tablets to all lots. In July and August, Pfizer had already issued recalls of several batches of popular anti-smoking drugs because they may contain too much of the carcinogenic N-nitroso-varenicline that meets or exceeds the Food and Drug Administration’s acceptable intake limit. United States.

Pfizer’s latest expanded recall is intended as a precautionary measure, the company said.

Reason for recall

“Long-term ingestion of N-nitroso-varenicline may be associated with a potential theoretical increased risk of cancer in humans, but there is no immediate risk for patients taking this drug. The health benefits of quitting smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline, ”Pfizer said in its recall notice, posted on the FDA website.

According to the FDA, 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 can increase the risk of cancer if people are exposed to them at levels above acceptable levels over long periods of time. “

Chantix is ​​designed to help people quit smoking, but it is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to have lung cancer than people who don’t smoke, according to the Centers for Disease Control and Prevention.

According to the FDA, there is no immediate risk to patients who take Chantix. But they should let their health care provider know to see if any alternative treatments are available.

Or, well, quit the cold turkey if you can.

Recalled products

Chantix products were distributed nationwide as well as to the U.S. Virgin Islands and Puerto Rico from May 2019 to September 2021.

These products include:

Chantix tablets, 0.5 mg NDC: 0069-0468-56 in the bottle format of 56 tablets with expiration dates from January 2022 to May 2023.

Chantix Tablets, 1 mg NDC: 0069-0469-56 in the bottle format of 56 tablets with expiration dates from September 2021 to December 2023.

Chantix recall product1-2.jpg
Recalled Chantix tablet lot numbers, 0.5 mg NDC: 0069-0468-56 in the 56 tablet vial format with expiration dates from January 2022 to May 2023. FDA

Chantix Tablets, 1 mg NDC: 0069-0469-03 in boxes containing four blister packs of 14 tablets each with expiration dates from September 2021 to June 2023.

Chantix recall product 3.jpg
Chantix, 1 mg tablet lot numbers NDC: 0069-0469-03 in boxes containing four blister packs of 14 tablets each with expiration dates from September 2021 to June 2023. FDA

Chantix tablets, 0.5 / 1 mg NDC: 0069-0471-03 in packs containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets with expiration dates from August 2021 to January 2023.

Chantix recall product 4.jpg
Lot numbers for Chantix, 0.5 / 1 mg tablets NDC: 0069-0471-03 in cartons containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets with expiration dates from August 2021 to January 2023. FDA

What you should do

Those who have received Chantix free of charge through Pfizer’s Patient Assistance Program or Pfizer’s Institutional Patient Assistance Program, check your bottles or cartons now. If you have them, call Stericycle to return the tablets. To request replacements, call 833-203-2776, 8 a.m. to 6 p.m. EST, Monday through Friday.

Wholesalers and distributors who have this inventory of Chantix tablets should stop selling or distributing them and immediately quarantine the product and notify anyone to whom you may have distributed Chantix, according to the FDA alert. . You can also contact Stericycle at 888-276-6166 between 8 a.m. and 5 p.m. Eastern Time.

This story was originally published September 17, 2021 3:39 pm.

Miami Herald Real Time / Breaking News reporter Howard Cohen, winner of the 2017 Media Excellence Awards, has covered pop music, theater, health and fitness, obituaries, city government, and general missions. He began his career in the Features department of the Miami Herald in 1991.
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