FDA Recalls Antidepressant Duloxetine Bottles With This Lot Number

Last updated: 2024/10/23 at 7:58 PM

By admin 2 Min Read

The U.S. Food and Drug Administration has recalled more than 7,000 bottles of duloxetine—an antidepressant sold under the brand name Cymbalta that’s often prescribed to treat chronic pain. The Class II recall was initiated due to the medication containing levels of N-nitroso-duloxetine, a toxic chemical. N-nitroso-duloxetine is part of a group of chemicals known as nitrosamines that can be toxic at high levels, potentially causing cancer. The FDA regulates its limit in products strictly.

Nitrosamines can be present in drugs due to the manufacturing process, chemical structure, or storage conditions. FDA continues to research possible sources for drugs containing nitrosamines. The recall is classified as Class II, indicating products can cause temporary health consequences. If you are taking the affected medications, consult with your healthcare provider before making any changes.

No. This recall pertains specifically to the 20mg Duloxetine Delayed-Release Capsules, packaged in 500-count bottles with lot number 220128 and expiration date 12/2024. A total of 7,104 bottles are included in the recall. Duloxetine, or Cymbalta, belongs to a class of medications known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), used for treating depression, anxiety, and nerve pain.

SSNRIs are typically taken daily and may take weeks to show effects. Gradual dose reduction is recommended when discontinuing SSNRIs to avoid withdrawal symptoms. If you are taking the recalled medication, consult with your healthcare provider for guidance on next steps.

Because of the withdrawal symptoms associated with SSNRIs, the FDA is recommending that anyone taking the batch of medications included in the recall consult with their provider about next steps, rather than stop taking the medication immediately.