Product: Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only,  Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Reason for recall: Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Recall initiated: 20191120
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated