Nationwide Recall: Over 12,000 Bottles of Popular Antidepressant Duloxetine
Health Alert: Breckenridge Pharmaceuticals has issued a voluntary recall of more than 12,000 bottles of duloxetine, a widely prescribed antidepressant, due to potential contamination risks. Learn what it means for patients and how to stay safe.
Why Was the Duloxetine Antidepressant Recalled?
The pharmaceutical company Breckenridge recalled 60 mg duloxetine delayed-release capsules after discovering the possibility of microbial contamination in packaging materials. While no adverse events have been reported, the recall was initiated as a precautionary measure.
The affected product bears the following identifiers:
- NDC Code: 0245-0146-05
- Lot Number: 1197230
- Expiration Date: August 2024
What Patients Should Know
Duloxetine (also known by brand names like Cymbalta) is commonly prescribed for:
- Major depressive disorder (MDD)
- Generalized anxiety disorder
- Chronic musculoskeletal pain
- Diabetic peripheral neuropathy
Steps to Take If You Have Affected Medication
- Check your prescription bottle for the matching NDC and lot numbers
- Do not stop taking any medication without consulting your healthcare provider
- Contact your pharmacist about replacement options
- Report any adverse effects to the FDA MedWatch program
Understanding the Potential Risks
While the contamination risk is low, possible effects of microbial exposure could include:
- Increased risk of infection for immunocompromised patients
- Potential reduction in drug effectiveness
- Possible digestive system irritation
The FDA continues to monitor the situation and will provide updates as needed. Patients with concerns should contact Breckenridge Pharmaceuticals at 1-800-237-1988 or the FDA at 1-888-INFO-FDA.
Last updated: [Current Date]
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