The FDA is recalling duloxetine, sold as Cymbalta, for chemical reasons

The Food and Drug Administration has announced a recall of thousands of bottles of the antidepressant drug duloxetine, sold under brand names such as Cymbalta, because it contains a chemical that can potentially cause cancer.

The recall went into effect on October 10th. More than 7,100 bottles of the drug have been recalled.

Here you will find everything you need to know.

Why is there a duloxetine recall?

The FDA states that “the presence of an impurity associated with the nitrosamine active substance (NDSRI), N-nitroso-duloxetine, is above the proposed interim limit.”

“The FDA, in collaboration with regulatory authorities around the world, has established internationally recognized acceptable daily intake limits for nitrosamines. Nitrosamines below this level are acceptable in drugs,” the FDA says on its website. “If medications contain levels of nitrosamine above the acceptable daily intake limit, the FDA recommends that those medications be recalled by the manufacturer.”

“Nitrosamine contaminants may increase the risk of cancer when people are exposed to them for an acceptable period of time and over a long period of time,” the agency adds, “but a person taking a medication that contains nitrosamines at or below acceptable daily intake limits. “It cannot be expected that every day over the age of 70 has an increased risk of cancer.”

What kind of callback is this?

The FDA calls this a Class II recall. According to the FDA, this is considered “a situation in which use or contact with a violating product may cause temporary or medically reversible adverse health effects, or in which the likelihood of serious adverse health effects is remote.”

What is being recalled?

The recall involves batch number 220128 with an expiration date of December 2024.

What should you do if your pills have been recalled?

The FDA recommends on its website that you contact your pharmacy to confirm whether your drug is actually part of a recall. If this is the case, you can speak to your pharmacist to find out what to do and whether you should look for an alternative medication.

“The FDA recommends that patients speak with their doctor if they have questions about their medicine because the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines. “The FDA and the international scientific community do not believe that nitrosamines are harmful when taken in small amounts,” the agency says.