FDA recall D-1235-2020

Aurobindo Pharma USA Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2020-03-18
Report date
2020-04-22
Termination date
2024-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1235-2020