Class I Recall: Dr Reddy's Levetiracetam Injection
Mislabeling creates threat of incorrect dosingWhat You Need to Know
Dr. Reddy’s Laboratories has issued an urgent recall for one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL due to a serious labeling error. The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL, while the outer packaging correctly states the actual product inside. This mislabeling could lead to patients receiving double the intended dose of the anti-seizure medication, posing a significant risk.
Why This Matters
Levetiracetam is used in hospitals and clinical settings to manage seizures when oral administration isn’t an option. The incorrect labeling could lead to overdose, which may cause serious and potentially life-threatening side effects, including:
- Respiratory depression
- Coma
- Severe dizziness, drowsiness, and confusion
- Liver injury
- Hypersensitivity reactions
- Coordination difficulties and agitation
Patients receiving rapid IV infusion for status epilepticus are at the highest risk of severe adverse effects.
What You Should Do
- Health Care Providers & Pharmacists: Check your inventory for the recalled lot. Immediately stop using, distributing, or administering the affected product and quarantine it for return or replacement.
- Wholesalers & Distributors: Notify any facilities that may have received the affected batch.
- Patients & Caregivers: If you or a loved one has received IV levetiracetam and are concerned about possible side effects, contact your healthcare provider immediately.
Contact Information
- For questions regarding the recall, Dr. Reddy’s Medical Information Call Center: 1-888-375-3784
- For product returns, Inmar: 1-877-645-1584
- To report adverse events, contact the FDA’s MedWatch Safety Program here.
Final Thoughts
While no adverse events have been reported yet, this recall underscores the importance of accurate labeling in medication safety. Health professionals should remain vigilant, and clinicians should ensure they administer the correct medication dosage.
For the latest updates and more information, visit the FDA’s official website or report concerns through the MedWatch Adverse Event Reporting Program.