FDA Recalls Over 7,000 Bottles of Duloxetine: What You Need to Know

FDA Recall: The U.S. Food and Drug Administration (FDA) has announced a Class II recall of more than 7,000 bottles of the antidepressant Duloxetine, commonly known under the brand name Cymbalta, due to the presence of a potentially cancer-causing chemical. This recall, initiated on October 10, has raised concerns among patients and healthcare professionals alike.

What Led to the Recall?

The FDA’s action stems from the discovery of N-nitroso-duloxetine, a nitrosamine impurity found in the medication, which can pose an increased cancer risk if consumed above acceptable levels over prolonged periods. While nitrosamines are commonly found in food and water, the FDA has stringent limits for their presence in pharmaceuticals. The recalled lot number is #220128, with an expiration date set for December 2024.

Details of the Recall

Number of Bottles Affected: A total of 7,107 bottles of Duloxetine, including 500-count delayed-release capsules, are impacted.

Health Risks: Classified as a Class II recall, this situation could lead to “temporary or medically reversible adverse health consequences,” according to the FDA.

Manufacturer: The product is manufactured by Towa Pharmaceutical Europe and was distributed nationwide.

What Should Patients Do?

The FDA urges individuals who have these specific bottles of Duloxetine to stop taking the medication immediately and consult their healthcare providers for alternative treatment options. Although the FDA emphasizes that patients should not abruptly stop any antidepressant medication without professional guidance, those with the recalled product should seek medical advice.

Understanding Nitrosamines

Nitrosamines, including N-nitroso-duloxetine, can be formed during the drug manufacturing process or even through the drug’s chemical structure. They are found in various foods and have been linked to cancer risks when present in significant quantities over time. The FDA has previously recalled other medications, such as heartburn drug Zantac and diabetes drug metformin, due to similar concerns regarding nitrosamines.

For more information and to view the official FDA notice, please visit the FDA website.