Recall report: Pfizer pulls even more Chantix lots as nitrosamine contamination worries grow

23 Sep 2021
endpts.com
It’s been a month since Pfizer was forced to recall bottles of its anti-smoking drug Chantix, but the counter was set back to zero last week as the company recalled all of its lots of 0.5 mg and 1 mg tablets due to increased levels of nitrosamines. Distribution of Chantix was stopped in June, and the company recalled four lots of the drug after finding elevated levels of cancer-causing nitrosamines. Then, in July, the FDA said it would still allow certain manufacturers to distribute batches of the drug that have more than the usual nitrosamine levels, so long as it remains under the interim acceptable limit. Officials at Pfizer originally said the drugmaker believed the benefits of the anti-smoking drug outweigh any potential risk of exposure to nitrosamines, and that those who have been taking it should continue to do so. It stuck by that mantra, but the most recent announcement featured extensive information about how to return the distributed batches and stop further distribution. “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 press release said. “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. “ Lots were distributed in the US, US Virgin Islands and Puerto Rico from May 2019 to September 2021. There’s a nitrosamine problem that goes deeper than just at Pfizer. Last year, the FDA found high levels of NDMA in some versions of generic diabetes drug metformin. 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. In 2018, drug pressure drug valsartan was pulled for the same reason. IntegraDose Compounding Services also announced Wednesday it would voluntarily recall nine lots of cefazolin for injection and two lots of cefazolin for injection, following issues of sterility. The lots all have expiration dates between Sept. 17, 2021, and Sept. 26, 2021.
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