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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Levofloxacin Injection Recalled for Visible Mold Contamination

Agency Publication Date: August 20, 2018
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Summary

AuroMedics Pharma LLC has recalled 6,072 bags of Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), a prescription antibiotic used to treat bacterial infections. This recall was initiated because the product contains visible particulate matter identified as mold. Consumers who have this medication should not use it and should immediately contact their healthcare provider or pharmacist, as mold in an injectable medication can lead to serious systemic infections.

Risk

Injecting a drug contaminated with mold can cause life-threatening infections or severe allergic reactions, as the fungus is introduced directly into the bloodstream or body tissues.

What You Should Do

  1. Check your medication to see if it is Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL) in a 50 mL single-use flexible container with NDC 55150-243-46.
  2. Locate the lot number on the packaging and confirm if it matches Lot CLF160003 with an expiration date of May 2018.
  3. If your product matches this lot, stop using it immediately and do not administer the injection.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative treatment and to report any adverse health effects.
  5. Return any unused bags from this lot to the pharmacy or place of purchase for a refund.
  6. Contact AuroMedics Pharma LLC for further instructions regarding the return or disposal of the affected product.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Guidance and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL)
Model:
NDC 55150-243-46
Lot Numbers:
CLF160003 (exp May 2018)
Date Ranges: May 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78932
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Sold By: hospitals; clinics
Manufactured In: United States, India
Units Affected: 6,072 bags
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.