Antidepressant Medication Recalled Due to Labeling Error

The U.S. Food and Drug Administration (FDA) recently announced that a popular antidepressant medication is being recalled by its manufacturer due to a labeling error. The drug is called Mirtazapine, and it’s manufactured by Aurobindo Pharma USA, Inc., for treatment of major depressive disorder. It’s being recalled because bottles labeled as containing 7.5 mg dosages of the medication may contain 15 mg tablets instead.

The FDA reports that people who take a higher dose than expected of the medication may experience a variety of side effects and complications, including:

  • Sedation
  • Agitation
  • Tremor
  • Sweating
  • Dilated pupils
  • Gastrointestinal distress
  • Nausea

The levels of sedation produced by the increased dosage could put people at risk, especially drivers and elderly patients. The affected lot number of the medication is 03119002A3, expiration date 03/2022. If you or someone you love was prescribed Mirtazapine, you can check the lot number by looking at the labeling information on the bottle or packaging. In addition, you should contact your doctor to determine what steps to take. Never stop taking a medication without talking to your doctor.

At Ferrer, Poirot & Wansbrough, it’s our job to constantly monitor the news for drug recalls, especially those with the potential to harm patients. And when people are hurt because of manufacturer error or negligence, we work hard to help them get maximum compensation for their medical bills, lost wages, and other drug injury-related expenses.

If you or someone you love was hurt by a recalled medication, we want to hear from you. Contact our drug injury lawyers today for a free consultation of your case.