Pfizer Expands Chantix Recall
July 19 2021 - 7:08PM
Dow Jones News
By Josh Beckerman
Pfizer Inc. has expanded its voluntary recall of its antismoking
pill Chantix, also known as varenicline.
The company said in June that it has suspended distribution and
recalled certain lots due to heightened levels of nitrosamines.
Pfizer has recalled 12 lots, adding that it hasn't received any
reports of adverse events related to the recall.
The company said, "there is no immediate risk to patients taking
this medication," and that "the health benefits of stopping smoking
outweigh the theoretical potential cancer risk from the nitrosamine
impurity."
The U.S. Food and Drug Administration said Friday that to
"ensure patient access to varenicline, FDA will not object to
certain manufacturers temporarily distributing varenicline tablets
containing N-nitroso-varenicline above FDA's acceptable intake
limit of 37 ng per day but below the interim acceptable intake
limit of 185 ng per day until the impurity can be eliminated or
reduced to acceptable levels."
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
July 19, 2021 19:03 ET (23:03 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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