CLASS I Drug recall · Reported 7 Mar 2018 · FDA Enforcement Report
Levofloxacin in 5% Dextrose Injection, 250 mg recalled
AuroMedics Pharma is recalling Levofloxacin in 5% Dextrose Injection, 250 mg/ (5 mg/mL) Single-Use flexible container, distributed nationwide in the US. The recall was initiated on 12 Jan 2018 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-0574-2018
- FDA event ID
- 78932
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Levofloxacin
- Manufacturer
- Eugia US LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 12 Jan 2018
- FDA classified
- 1 Mar 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Mold
- Drug class
- Antibiotics
Timeline
| 12 Jan 2018 | Recall initiated by company | |
| 1 Mar 2018 | Classified by FDA | +48 days |
| 7 Mar 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; contains visible particulate matter identified as mold.
Product as listed by the FDA
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Where it was distributed
Nationwide
Questions about this recall
Is Levofloxacin in 5% Dextrose Injection, 250 mg/ (5 mg/mL) Single-Use flexible container recalled?
Yes. AuroMedics Pharma recalled Levofloxacin in 5% Dextrose Injection, 250 mg/ (5 mg/mL) Single-Use flexible container on 12 Jan 2018. The recall is Class I and its status is Terminated. Recall number D-0574-2018.
Why was it recalled?
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Which lots are affected?
Lot CLF160003, exp May 2018
Where was it sold?
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 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 21 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, 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 Levofloxacin In 5% Dextrose recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin recalledLevofloxacin | AuroMedics Pharma | Mold | Nationwide |
| Drug | CLASS II | Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin recalledLevofloxacin | AuroMedics Pharma | Mold | Nationwide |
| Drug | CLASS II | Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin recalledLevofloxacin | AuroMedics Pharma | Mold | Nationwide |