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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: Linezolid Injection Recalled Due to Mold Contamination

Agency Publication Date: February 8, 2018
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Summary

AuroMedics Pharma LLC has recalled approximately 9,050 bags of Linezolid Injection 600 mg/300 mL (2 mg/mL), a prescription antibiotic used to treat serious bacterial infections. The recall was issued because white particulate matter identified as mold was found inside one of the infusion bags. These products are clear liquids packaged in 300 mL single-use flexible plastic infusion bags inside a foil overwrap. If you have this medication, you should immediately contact your healthcare provider or pharmacist for instructions.

Risk

Injecting a medication contaminated with mold can cause serious or life-threatening systemic infections, especially in patients who are already ill or have weakened immune systems. Additionally, the presence of any particulate matter in an intravenous drug can lead to the blockage of blood vessels or dangerous inflammatory reactions.

What You Should Do

  1. Check your medical supplies for Linezolid Injection 600 mg/300 mL (2 mg/mL) in 300 mL single-use infusion bags with NDC number 55150-242-51.
  2. Identify if your product is part of the affected lot by looking for Lot # CLZ160007 with an expiration date of August 2018 printed on the packaging.
  3. If you identify an affected bag, do not use it. Immediately contact your healthcare provider or pharmacist to discuss your treatment and arrange for a replacement.
  4. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund, and contact AuroMedics Pharma LLC at their East Windsor, NJ location for further instructions.
  5. For additional questions or to report a problem, 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use infusion bag
Model:
NDC 55150-242-51
Recall #: D-0337-2018
Lot Numbers:
CLZ160007 (Exp August 2018)
Date Ranges: August 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78800
Status: Resolved
Manufacturer: AuroMedics Pharma LLC
Manufactured In: India, United States
Units Affected: 9,050 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.