"FDA Alert: 12K Bottles of Antidepressant Recalled Nationwide"
"FDA Alert: 12K Bottles of Antidepressant Recalled Nationwide"
Mental Health in the Spotlight
Once considered a taboo topic, mental health and wellness have gained more attention in recent years, with nearly a quarter of American adults living with a mental illness, according to the National Institute of Mental Health.
Common Medications for Depression
Depression is one of the most common mental health issues in the U.S. According to data from the National Center for Health Statistics, doctors often prescribe medications like selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) to treat depression.
Recall Alert: Duloxetine Capsules
The U.S. Food and Drug Administration (FDA) recently announced the nationwide recall of 12,242 30-count bottles of Duloxetine Delayed-Release Capsules, a popular antidepressant used to treat depression, anxiety, fibromyalgia, and chronic nerve pain.
Reason for Recall
The FDA attributed the recall to "CGMP Deviations," indicating that the medication did not comply with Current Good Manufacturing Practice regulations. The presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit was cited as the specific reason.
Identifying Details of the Recalled Medication
- 30-count bottles of Duloxetine Delayed-Release Capsules, USP, 40 milligrams (mg)
- Manufactured by Towa Pharmaceutical Europe, S.L. Martorelles, Spain
- Distributed by Breckenridge Pharmaceuticals, Inc., Berkeley Heights, New Jersey
- National Drug Code (NDC): 51991-750-33
- Lot number: 230199
- Expiration date: 01/31/2026
Previous Recall and Class II Risk
Both the manufacturer, Towa Pharmaceutical Europe, and the distributor, Breckenridge Pharmaceuticals, Inc., were previously associated with a duloxetine recall for the same reason. The recall, labeled as a Class II risk, may cause temporary or medically reversible adverse health effects.
Stay Informed
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Other Recalls to Note:
- Walmart Just Recalled 850,000 Water Bottles Nationwide
- Nearly 640,000 Blood Sugar Devices Have Been Recalled at the Nation's Highest Risk Level
- More Than 33,000 Blood Pressure Drugs Have Been Recalled Nationwide
- Nearly 200,000 Eye Drop Products Have Been Recalled Nationwide
Conclusion
It's essential to stay informed about medication recalls to ensure your health and safety. If you are taking Duloxetine Delayed-Release Capsules, check the identifying details provided and consult your healthcare provider if you have any concerns.
The post More than 12,000 Bottles of a Popular Antidepressant Have Been Recalled Nationwide appeared first on The Healthy.
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