Recall: D-1235-2020

Class II - Potentially Harmful

Class IIClassification

2020-03-18Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

Product

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

Reason

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.