Thousands of bottles of the antidepressant duloxetine, which is the generic version of Cymbalta, have been recalled due to the presence of a toxic chemical, according to a notice from the Food and Drug Administration.
The October 10 recall is due to the presence of N-nitroso-duloxetine, a chemical that is toxic if swallowed and is suspected of causing cancer, according to the National Library of Medicine. The FDA classified the recall as Class II, which means that the drug could cause “temporary or medically reversible adverse health consequences.”
The medication, manufactured by Towa Pharmaceutical Europe, was distributed nationally throughout the U.S., according to the recall notice.
In a statement emailed to CBS MoneyWatch, the FDA said it “recommends patients talk to their health care professional about the best course of action for their health if they have a medication that has been recalled.”
Towa Pharmaceutical sent a statement that pointed to the FDA’s comment, as well as a recommendation from the agency that patients taking prescriptions “with potential nitrosamine impurities should not stop taking their medications.”
The company noted that the FDA is investigating the source of the chemicals in the recalled duloxetine and pointed customers to an agency website about nitrosamine impurities in drugs.
People taking certain medications, including duloxetine, shouldn’t suddenly stop taking them due to the risk of adverse reactions, according to Healthline.
Duloxetine recall
The recall covers 7,107 bottles of duloxetine, the FDA said. The bottles include 500 delayed-release 20mg capsules. The lot number is 220128, with an expiration date of 12/2024.
Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSRI), is prescribed for anxiety and depression, and can also be used to treat nerve pain for people with diabetes, the Mayo Clinic notes. It’s also used for people with fibromyalgia and chronic pain related to bones and muscles, it adds.