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FDA Medwatch Alert: Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

December 31, 2019 – Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on...

FDA Medwatch Alert: Remeron (mirtazapine)

[UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject...

FDA Medwatch Alert: Antidepressant Medication Products

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information...

FDA Medwatch Alert: Public Health Advisory: Antidepressant Use in Children, Adolescents, and Adults

The FDA asked manufacturers of the following antidepressant drugs to include in their labeling a Warning statement that recommends close observation of adult and pediatric patients for worsening...

FDA Medwatch Alert: Public Health Advisory - Suicidality in Pediatric Patients Treated with Antidepressants for Major Depressive Disorder

The FDA notified healthcare professionals of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric...

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Depression, Major Depressive Disorder

Remeron patient information at Drugs.com