Food, drugs, devices › AuroMedics Pharma LLC

Drug recall: Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810

FDA enforcement event 84336 · Class I · initiated 20 Nov 2019 · status Terminated · terminated 21 Feb 2024

DrugVoluntary: Firm initiated2 product recordsEast Windsor, NJ

FDA enforcement event 84336 is a drug recall by AuroMedics Pharma LLC of East Windsor, NJ, initiated 20 Nov 2019 and classified Class I, with 2 product records.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 21 Feb 2024. Initiation: voluntary: firm initiated. AuroMedics Pharma LLC has 23 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

AuroMedics Pharma LLC, East Windsor, NJ.

Reason for recall

"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."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0636-2020	Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05	N/A	Class I	Terminated	18 Dec 2019
D-0637-2020	Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05	N/A	Class I	Terminated	18 Dec 2019

Context

10%of 2019 drug events are Class I362 events that year

2product records in this eventfirm median: 1

23events on this register for the firm

Other enforcement events for AuroMedics Pharma LLC

Initiated	Product (first record)	Type	Class	Records
30 Sep 2022	Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma	Drug	Class II	1
26 Sep 2022	Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics	Drug	Class III	1
26 Sep 2022	Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC	Drug	Class II	1
26 Jan 2022	Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, D	Drug	Class I	1
30 Dec 2020	Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed b	Drug	Class II	1
7 Feb 2020	Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma US	Drug	Class II	1
7 Feb 2020	Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intrav	Drug	Class III	1
2 Dec 2019	Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed b	Drug	Class III	1
25 Nov 2019	Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in Indi	Drug	Class II	1
19 Nov 2019	Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99	Drug	Class II	1

All 23 events for AuroMedics Pharma LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "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."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Feb 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.