CLASS I Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Linezolid Injection 600 mg/ (2 mg/mL) Single-use recalled
AuroMedics Pharma is recalling Linezolid Injection 600 mg/ (2 mg/mL) Single-use, ready-to-use flexible in a. The recall was initiated on 20 Dec 2017 and the FDA has classified it as Class I.
Check your package
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-0337-2018
- FDA event ID
- 78800
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Linezolid
- Manufacturer
- Eugia US LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Dec 2017
- FDA classified
- 8 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Antibiotics
Timeline
| 20 Dec 2017 | Recall initiated by company | |
| 8 Feb 2018 | Classified by FDA | +50 days |
| 14 Feb 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
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Product as listed by the FDA
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
Where it was distributed
Product was distributed throughout United States.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Which lots are affected?
Lot # CLZ160007, Exp August 2018
Where was it sold?
Product was distributed throughout United States.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | 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 |
|---|---|---|---|---|---|
| Drug | CLASS II | Linezolid Injection 600 mg recalled by AuroMedics PharmaLinezolid | AuroMedics Pharma | Mold | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection, 600 mg/ Single use container bags recalled | Teva North America | Sterility | Nationwide |