NDC 13107-031

Mirtazapine 15 mg tablet, film coated

Where it's made

Factory	Where	Role	Last FDA inspection
Apl Healthcare Limited	Tirupati, India	Makes it and tests it	Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections
Aurobindo Pharma Limited	Medchal, India	Makes it	Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action
Aurolife Pharma LLC	Dayton, NJ, United States	Makes it	Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action
Aurolife Pharma LLC	Dayton, NJ, United States	Packages it and labels it	Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action

Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 031180028A, Exp. Date 03/2021
Nov 20, 2019 · Class I · AuroMedics Pharma LLC
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.
Lots: Lot #: 03119002A3, Exp 3/2022
Nov 20, 2019 · Class I · AuroMedics Pharma LLC
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.
Lots: Lot #: 03119002A3, Exp 3/2022

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Mirtazapine: every company that makes it
Form: tablet, film coated, oral
Strength: 15 mg
Approval: ANDA ANDA076921
On the market since: Aug 17, 2009
Package NDCs: 13107-031-01 13107-031-05 13107-031-30 13107-031-32 13107-031-34 13107-031-60 13107-031-90
Official label: DailyMed (National Library of Medicine), updated Sep 10, 2025

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