AuroMedics Levofloxacin Injection Recall: Mold Particulate Hazard
AuroMedics Pharma recalls levofloxacin injection with visible mold particles. Stop using if you have this specific product. Contact for details.
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Presence of Particulate Matter; contains visible particulate matter identified as mold.
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What happened, in plain English
AuroMedics Pharma recalls a specific levofloxacin injection product due to visible mold particles. This poses a risk of infection if the medication is used. Read more at govinfonow.com/recall/40932-auromedics-levofloxacin-injection-recall-mold-particulate-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/40932-auromedics-levofloxacin-injection-recall-mold-particulate-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0574-2018
Cite this page
“AuroMedics Levofloxacin Injection Recall: Mold Particulate Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40932-auromedics-levofloxacin-injection-recall-mold-particulate-hazard. Based on FDA recall #D-0574-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2018%22&limit=1).
Why it’s dangerous
The injection contains visible mold particles that can cause infections if the medication is administered. Using this product could lead to serious health issues due to the mold contamination.
Who’s affected
Patients prescribed this specific levofloxacin injection by a healthcare provider. Those with the product's NDC 55150-243-46 and lot number CLF160003 are most at risk.
How to tell if you have this one
Check for the product name 'Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container'. Look for NDC 55150-243-46 and lot number CLF160003.
- Brand
AuroMedics- Category
Drug
What to do — step by step
Stop Using Now
Immediately discard the product if you have it.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0574-2018 (January 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0574-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.