Recall report: More Chantix lots pulled from shelves as nitrosamine woes continue
Another four lots of Pfizer’s popular anti-smoking drug have been recalled due to high levels of nitrosamine, the FDA announced.
Pifzer halted distribution of Chantix and recalled four lots of the drug in June, after finding elevated levels of cancer-causing nitrosamines. Despite the recall, an official at Pfizer Korea said the company believes the benefits of the non-smoking drug outweigh any potential risk of exposure to nitrosamines, and that those who have been taking it should continue to do so.
Then in July, the FDA said it would still allow certain manufacturers to distribute batches of drug that have more than the usual nitrosamine levels, so long as it remains under the interim acceptable limit.
The Chantix recall is a part of a larger nitrosamine problem. Last year, the FDA found high levels of NDMA in some versions of metformin, a popular generic diabetes drug. Before Pfizer, Viona Pharmaceuticals issued a recall for two lots of its 750 mg extended-release metformin tablets, and since November 2020, there have been two more drugs recalled because of reports of NDMA, representative of a larger issue in the industry that started in 2018 when the blood pressure drug valsartan was pulled for the same reason.
The expansion of the recall comes as Endo’s Par Pharmaceutical has released the first generic version of Chantix after Pfizer has hauled in tens of billions of dollars from the drug since its FDA approval in 2006. Between 2017 and 2020, the drug brought in $4 billion.
SterRx also is voluntarily recalling three lots of sodium bicarbonate injection, used to treat heartburn, high potassium and irregular heartbeat. The product comes in 1000 mL IV bags, and the bags recalled were distributed to US hospitals from May to June. The lots have expiration dates of March 23, 2022, March 16, 2022 and March 8, 2022.