Potential Overdose Risk Triggers National Recall
A nationwide recall has been issued for Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL, after it was discovered that some infusion bags were mislabeled as a lower-dose formulation. The U.S. Food and Drug Administration (FDA) announced that the incorrect labeling on the infusion bags could lead to severe health complications, including respiratory depression, coma, and life-threatening neurological effects.
The affected medication is an intravenous seizure treatment used in patients 16 and older when oral administration is not an option. Because of the incorrect labeling, patients could receive double the intended dose, increasing the risk of adverse reactions, organ damage, and serious neurological complications.
The recalled batch was distributed nationwide between November 4, 2024, and November 6, 2024, reaching hospitals, pharmacies, and wholesalers. While no adverse events have been officially reported, the risks posed by this mislabeling are severe enough to warrant an immediate recall. The FDA has advised healthcare providers and distributors to stop using and return the affected products to prevent potential harm to patients.
The Dangers of Mislabeling in Injectable Medications
Patients receiving Levetiracetam intravenously are often in critical condition, with seizures requiring rapid and precise medical intervention. Any dosing error, particularly a double-strength administration, could lead to severe toxicity. Potential complications include:
- Respiratory depression and difficulty breathing
- Loss of coordination and motor control
- Severe fatigue, drowsiness, and loss of consciousness
- Liver damage or hematological toxicity
- Agitation, aggression, and psychological disturbances
For patients receiving high doses of Levetiracetam to treat status epilepticus, the risk of complications is significantly higher. These individuals already require carefully managed dosing, and a mislabeling mistake could have catastrophic consequences.
Medication recalls involving incorrect labeling are particularly dangerous in hospital settings, where nurses, pharmacists, and doctors rely on accurate dosage information. Administering the wrong dose can lead to permanent organ damage or neurological impairment, making this recall a serious threat to patient safety.
Legal Options for Patients Harmed by Defective Medication
When a mislabeling error results in overdosing, severe side effects, or long-term health complications, affected individuals may have the right to pursue legal action. Patients rely on accurate drug labeling to ensure they receive the correct treatment, and any failure to meet safety standards can lead to a product liability lawsuit.
Pharmaceutical companies and distributors are legally responsible for ensuring that medications are properly labeled, tested, and safe for patient use. When errors occur, and patients suffer harm, legal action can hold these companies accountable for the damages caused.
Victims who have suffered severe side effects from this mislabeling may be able to recover compensation for:
- Medical expenses from hospitalization and emergency care
- Lost wages due to extended recovery time
- Pain and suffering for physical and emotional distress
- Permanent disability compensation for long-term health impacts
- Wrongful death damages if a patient died as a result of the medication error
Pharmaceutical lawsuits require strong medical evidence linking the recalled product to the harm suffered. Victims should seek immediate legal advice to understand their rights and the legal steps required to file a claim.
Why Legal Representation Is Critical in Pharmaceutical Recall Cases
Lawsuits against pharmaceutical companies require extensive evidence, expert medical testimony, and aggressive legal advocacy. These corporations often deny responsibility, minimize injuries, or blame healthcare providers for administration errors. Without legal representation, many victims struggle to obtain the compensation they deserve.
An attorney can assist by:
- Gathering medical records and pharmacy documentation proving exposure to the recalled drug
- Working with medical experts to establish a direct link between the mislabeling error and the patient’s injuries
- Negotiating with pharmaceutical companies to secure fair compensation
- Filing a lawsuit if the company refuses to accept responsibility
Pharmaceutical litigation is complex, and having an experienced legal team ensures that victims do not face these powerful corporations alone.
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