Drug recall: Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil…

Class I FDA enforcement event 78800. Recall start date: 20 Dec 2017. Status in the FDA record: Terminated. Termination date: 24 Jun 2019.

Reason for recall, in the words of FDA

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

Class I, in the words of FDA

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

AuroMedics Pharma LLC started this drug recall on 20 Dec 2017. The firm address in the FDA record is in East Windsor, NJ. FDA put the recall in Class I. FDA event 78800 has 1 product record. The first FDA enforcement report date is 14 Feb 2018. The record gives the status Terminated, with the termination date 24 Jun 2019.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Product was distributed throughout United States.

Recalling firm

AuroMedics Pharma LLC, East Windsor, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 78800: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0337-2018	Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51	9,050 bags	Class I	Terminated	14 Feb 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Drug events that started in 2017: 343
Share of these events in Class I: 13%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 23

Other events of the firm

Other FDA enforcement events of 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
20 Nov 2019	Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810	Drug	Class I	2

AuroMedics Pharma LLC: all 23 events

Official channels

FDA enforcement report D-0337-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 78800. https://recallregister.com/fda/i/78800/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Product was distributed throughout United States.
What quantity of product is in FDA event 78800?: The FDA record gives this quantity: 9,050 bags
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2017 have the same class?: 13% of the 343 drug events that started in 2017 are in Class I.