Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Recall Number: D-1235-2020
Firm: Aurobindo Pharma USA Inc.
Classification: Class II
Status: Terminated
Report Date: 20200422
Initiation Date: 20200318
Termination Date: 20240325
Reason for Recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product Description
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34