CLASS II Drug recall · Reported 9 May 2018 · FDA Enforcement Report

Linezolid Injection 600 mg recalled by AuroMedics Pharma

AuroMedics Pharma is recalling Linezolid Injection 600 mg per (2 mg/mL) For Intravenous Administration, distributed nationwide in the US. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Batch #'s: CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018; CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019; CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019; CLZ170011, CLZ170012, exp June 2019; CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019; CLZ170017, exp October 2019

NDC55150-242

Quantity recalled395150 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0703-2018
FDA event ID: 79772
Recalling firm: AuroMedics Pharma, East Windsor, NJ
Brand: Linezolid
Manufacturer: Eugia US LLC
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2018
FDA classified: 3 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Mold
Drug class: Antibiotics

Timeline

27 Mar 2018	Recall initiated by company
3 May 2018	Classified by FDA	+37 days
9 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Product as listed by the FDA

Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Which lots are affected?

Lot/Batch #'s: CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018; CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019; CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019; CLZ170011, CLZ170012, exp June 2019; CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019; CLZ170017, exp October 2019

Where was it sold?

US Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 79772

This product is part of a recall event; the main page for the event is Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin recalled.

Reported	Class	Recall	Company	Reason	Where
9 May 2018	CLASS II	Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin recalledLevofloxacin	AuroMedics Pharma	Mold	Nationwide
9 May 2018	CLASS II	Levetiracetam in 0.54% Sodium Chloride Injection recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide
9 May 2018	CLASS II	Levetiracetam in 0.82% Sodium Chloride Injection recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide
9 May 2018	CLASS II	Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin recalledLevofloxacin	AuroMedics Pharma	Mold	Nationwide
9 May 2018	CLASS II	Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin recalledLevofloxacin	AuroMedics Pharma	Mold	Nationwide
9 May 2018	CLASS II	Levetiracetam in 0.75% Sodium Chloride Injection recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide

More recalls from AuroMedics Pharma

All 36

Reported	Class	Recall	Company	Reason	Where
2 Nov 2022Drug	CLASS II	Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium	AuroMedics Pharma	Potency & Assay	Nationwide
26 Oct 2022Drug	CLASS II	Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium	AuroMedics Pharma	Particulate Matter	Nationwide
12 Oct 2022Drug	CLASS III	Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid	AuroMedics Pharma	Particulate Matter	Nationwide
16 Feb 2022Drug	CLASS I	Polymyxin B for Injection USP per Vial vials recalledPolymyxin B	AuroMedics Pharma	Particulate Matter	Nationwide
10 Feb 2021Drug	CLASS II	Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen	AuroMedics Pharma	Other	Nationwide

Other Linezolid recalls

All 4

Reported	Class	Recall	Company	Reason	Where
14 Feb 2018Drug	CLASS I	Linezolid Injection 600 mg/ (2 mg/mL) Single-use recalledLinezolid	AuroMedics Pharma	Mold	NJ
14 Sep 2016Drug	CLASS II	Linezolid Injection 600 mg recalled by Teva North America	Teva North America	Manufacturing (CGMP) Deviations	Nationwide
1 Jun 2016Drug	CLASS II	Linezolid Injection, 600 mg/ Single use container bags recalled	Teva North America	Sterility	Nationwide