Mirtazapine Tablet, Film Coated
FDA Recall NDC 13107-032
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Mirtazapine (NDC 13107-032). A significant event, classified as Class II, was initiated on Mar 18, 2020 by Aurolife Pharma Llc. The reported reason for this action was: "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
56208 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Batch or Lot Expiration Information
Lot# : 031180028A, Exp. Date 03/2021
Affected Packages Involved in this Recall
13107-001-30Product
13107-001-60Product
13107-001-90Product
13107-001-01Product
13107-001-05Product
13107-031-30Product
13107-031-34Product
13107-031-60Product
13107-031-90Product
13107-031-01Product
13107-031-05Product
13107-031-32Product
13107-003-30Product
13107-003-34Product
13107-003-60Product
13107-003-90Product
13107-003-01Product
13107-003-05Product
13107-003-32Product
13107-032-34Product
13107-032-60Product
13107-032-90Product
13107-032-01Product
13107-032-05Product
13107-032-32Product
Class I Terminated
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.
Nov 20, 2019
Dec 18, 2019
N/A
Recall Profile & Regulatory Data
Event ID
84336
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 21, 2024
Product Description
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Batch or Lot Expiration Information
Lot# : 03119002A3, Exp 3/2022
Affected Packages Involved in this Recall
13107-001-30Product
13107-001-60Product
13107-001-90Product
13107-001-01Product
13107-001-05Product
13107-031-30Product
13107-031-34Product
13107-031-60Product
13107-031-90Product
13107-031-01Product
13107-031-05Product
13107-031-32Product
13107-003-30Product
13107-003-34Product
13107-003-60Product
13107-003-90Product
13107-003-01Product
13107-003-05Product
13107-003-32Product
13107-032-34Product
13107-032-60Product
13107-032-90Product
13107-032-01Product
13107-032-05Product
13107-032-32Product
Class I Terminated
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.
Nov 20, 2019
Dec 18, 2019
N/A
Recall Profile & Regulatory Data
Event ID
84336
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 21, 2024
Product Description
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Batch or Lot Expiration Information
Lot# : 03119002A3, Exp 3/2022
Affected Packages Involved in this Recall
13107-001-30Product
13107-001-60Product
13107-001-90Product
13107-001-01Product
13107-001-05Product
13107-031-30Product
13107-031-34Product
13107-031-60Product
13107-031-90Product
13107-031-01Product
13107-031-05Product
13107-031-32Product
13107-003-30Product
13107-003-34Product
13107-003-60Product
13107-003-90Product
13107-003-01Product
13107-003-05Product
13107-003-32Product
13107-032-34Product
13107-032-60Product
13107-032-90Product
13107-032-01Product
13107-032-05Product
13107-032-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
