Antidepressant Duloxetine Recalled Over Toxic Chemical

Thousands of Bottles Impacted

The U.S. Food and Drug Administration (FDA) has recalled thousands of bottles of the antidepressant duloxetine over the presence of a toxic chemical. According to an October 10 notice from the agency, the recall involves 7,107 bottles of duloxetine, which is sold under the brand name Cymbalta.

Duloxetine: An Antidepressant Medication

Duloxetine is part of a class of drugs called selective serotonin/norepinephrine reuptake inhibitors (SNRIs). It is used to treat depression, anxiety, and other mood disorders, according to the FDA.

The Presence of N-nitroso-duloxetine

The FDA issued the recall due to the presence of N-nitroso-duloxetine above the proposed interim limit. N-nitroso-duloxetine is toxic if swallowed and suspected of causing cancer, according to the National Library of Medicine.

Recalled Product Details

The recalled capsules are 20mg in strength and sold in 500-count bottles. The lot number for the recalled products is 220128 with an expiration date of December 2024 and manufactured by Towa Pharmaceutical Europe, according to the FDA.

Recall Classification

The recall is designated as a Class II, meaning the product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the FDA.

Risks Associated with N-nitroso-duloxetine

N-nitroso-duloxetine is a chemical compound that can increase the risk of cancer if consumed at elevated concentrations, according to the FDA.

What Should You Do?

Patients who take this medication should contact their healthcare provider. The FDA did not issue specific guidance on what to do with the recalled duloxetine.

Conclusion

The recall is a serious concern, as N-nitroso-duloxetine is toxic and potentially carcinogenic. Patients who are taking duloxetine should work with their healthcare provider to determine the best course of action.

FAQs

• What is the purpose of the recall?
  The purpose of the recall is to remove from the market duloxetine products that contain the toxic chemical N-nitroso-duloxetine.
• What is N-nitroso-duloxetine?
  N-nitroso-duloxetine is a chemical compound that can increase the risk of cancer if consumed at elevated concentrations.
• What should I do if I’m taking duloxetine?
  Patients who take this medication should contact their healthcare provider to determine the best course of action.
• What is the expiration date of the recalled products?
  The expiration date of the recalled products is December 2024.
• Who is responsible for the recall?
  The Towa Pharmaceutical Europe is responsible for the manufacture of the recalled products.