NDC 43353-536

Mirtazapine 30 mg tablet, film coated

On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Aurolife Pharma LLC's NDC 13107-003.

Where the pills inside were 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

Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it

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
Strength: 30 mg
Approval: ANDA ANDA076921
On the market since: Aug 17, 2009
Package NDCs: 43353-536-15 43353-536-30 43353-536-45 43353-536-53 43353-536-60
Official label: DailyMed (National Library of Medicine), updated Dec 18, 2019

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