Aurobindo Pharma USA Inc. recalls Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, N
Recalled April 22, 2020 · FDA recall D-1235-2020 · Aurobindo Pharma USA
Hazard
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed · FDA Class II
Units
56208 units
Sold at
Nationwide within the United States
Description
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Manufacturer(s)
Aurobindo Pharma USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →