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The Food and Drug Administration announced a Class II recall for more than 7,000 bottles of an antidepressant due to a chemical.
The recall was initiated earlier this month on Oct. 10.
Duloxetine, reportedly known under brands like Cymbalta, is used to treat mental health disorders like anxiety and depression, among other conditions, according to the Cleveland Clinic. The product was distributed across the country and manufactured by Towa Pharmaceutical Europe.
The agency noted the medication had the “presence” of nitrosamine drug substance impurity, N-nitroso-duloxetine.
Per the FDA, nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
However, it added, “a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”
Here’s what we know about the recall:
How many bottles were recalled?
According to the notice, 7,107 bottles were recalled (delayed-release capsules 500 count bottles included.)
It was classified as Class II meaning exposure could trigger “temporary or medically reversible adverse health consequences,” the FDA said.
Which lot of the medication is being recalled?
According to the FDA, the recalled lot was #220128, expiring December 2024.
What should you do if your medication is recalled?
Officials urge those who may have medications with potential nitrosamine to stop taking them.
“Patients should talk to their health care professionals about concerns and other treatment options,” the FDA’s website says.
What are nitrosamines?
Nitrosamines are found in water, cured and grilled meats, dairy products and vegetables, according to the FDA. While nearly everyone is exposed to trace amounts of nitrosamines, studies link the contaminants to increased cancer risk if people are exposed to large amounts over long periods of time.
More than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market since 2018 because they contained nitrosamines.
The same family of contaminants triggered past recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking cessation medication Chantix.
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