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More than 7,000 bottles recalled

“Patients should speak with their healthcare provider about concerns and other treatment options,” the FDA website says.

The Food and Drug Administration announced a Class II recall of more than 7,000 bottles of an antidepressant due to a chemical.

The recall was initiated earlier this month on October 10th.

According to the Cleveland Clinic, duloxetine, reportedly known by brands such as Cymbalta, is used to treat mental disorders such as anxiety and depression, among other things. The product was distributed nationwide and manufactured by Towa Pharmaceutical Europe.

The authority found that the drug contained contamination of the nitrosamine active ingredient N-nitroso-duloxetine.

According to the FDA, nitrosamine contaminants “may increase the risk of cancer when people are exposed to them above acceptable levels and for extended periods of time.”

However, it added: “A person taking a drug containing nitrosamines at or below the acceptable daily intake limit every day for 70 years would not be expected to have an increased risk of cancer.”

Here's what we know about the recall:

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How many bottles have been recalled?

According to the notice, 7,107 bottles have been recalled (including 500 sustained-release capsules).

It has been classified as Class II, meaning exposure could cause “transient or medically reversible adverse health effects,” according to the FDA.

Which batch of medication is being recalled?

According to the FDA, the recalled lot was #220128, which expires in December 2024.

What should you do if your medication is recalled?

Officials are urging those who may be taking medications with potential nitrosamine to stop taking them.

“Patients should speak with their healthcare provider about concerns and other treatment options,” the FDA website says.

What are Nitrosamines?

According to the FDA, nitrosamines are found in water, sausage and grilled meat, dairy products and vegetables. While almost everyone is exposed to trace amounts of nitrosamines, studies link the pollutants to an increased risk of cancer when people are exposed to large amounts over a long period 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 pollutants has previously triggered recalls of the heartburn drug Zantac, the diabetes drug Metformin and the smoking cessation drug Chantix.

The story has been updated to correct a spelling error.

Contributor: Ken Alltucker

Taylor Ardrey is a news reporter for USA TODAY. You can reach her at [email protected].

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