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FDA recalls Duloxetine, sold as Cymbalta, due to chemicals
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FDA recalls Duloxetine, sold as Cymbalta, due to chemicals

The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names such as Cymbalta, due to the presence of a chemical that may cause cancer.

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

Here’s everything you need to know.

Why is there a recall for duloxetine?

The FDA says there is “presence of nitrosamine drug-related impurities (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.”

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

“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and for long periods of time,” the agency adds, “but someone taking a drug containing nitrosamines at or below acceptable daily intake limits is not expected to that every day for 70 years will have an increased risk of cancer.”

What kind of memory is this?

The FDA calls this a Class II recall. That is considered “a situation in which use of or exposure to an infringing product may cause temporary or medically reversible adverse health effects or where the likelihood of serious adverse health effects is remote,” according to the FDA.

What is being recalled?

The recall concerns lot number 220128, with an expiration date of December 2024.

What should you do if you have pills that have been recalled?

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

“The FDA encourages patients to talk to their healthcare provider 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 expect nitrosamines to cause harm when ingested in small amounts,” the agency said.