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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

Mylan Institutional Inc: Levoleucovorin Injection Recalled for Particulate Matter (Copper Salts)

Agency Publication Date: March 13, 2019
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Summary

Mylan Institutional Inc. is recalling 11,964 cartons (each containing 30 vials) of Levoleucovorin Injection, 250 mg/25 mL (10 mg/mL). This prescription medication is being recalled because copper salt particulate matter was identified in some vials. Consumers who have this medication should contact their healthcare provider or pharmacist immediately, as the presence of foreign particles in an injectable drug can lead to serious health complications.

Risk

The administration of an injectable product containing particulate matter, such as copper salts, can cause local inflammation, granulomatous formation, or more serious systemic issues like embolism or blood vessel blockage. These particulates can trigger an immune response or cause damage to internal organs when injected into the bloodstream.

What You Should Do

  1. Check your medication vials for Levoleucovorin Injection, 250 mg/25 mL (10 mg/mL), 25 mL Single-Use Vials with NDC 67457-601-30.
  2. Verify if your product belongs to Lot # APB032 or Lot # APB033, both with an expiration date of April 2019.
  3. Immediately stop using the affected medication and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  4. Return any unused product from the affected lots to your pharmacy for a refund and contact Mylan Institutional LLC for further return instructions.
  5. 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

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: Levoleucovorin Injection, 250 mg/25 mL (10 mg/mL), 25 mL Single-Use Vial
Model:
NDC: 67457-601-30
Recall #: D-1059-2019
Lot Numbers:
APB032 (Exp. April 2019)
APB033 (Exp. April 2019)
Date Ranges: April 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82210
Status: Resolved
Manufacturer: Mylan Institutional Inc
Manufactured In: India, United States
Units Affected: 11,964 cartons of 30 vials
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.