Dr Reddy's Laboratories has announced a voluntary recall of a batch of Levetiracetam injection bags in the US market after discovering labelling discrepancies that could lead to patients receiving double the intended dose, posing severe health risks.

Key Highlights
Reason for Recall

• Lot No: A1540076 of Levetiracetam 0.75% Sodium Chloride Injection, 1,000 mg/100 mL recalled.

• The infusion bag incorrectly labelled as Levetiracetam 0.82% Sodium Chloride Injection 500 mg/100 mL.

• Aluminum overwrap packaging correctly identifies the product, creating confusion.

Risk to Patients

• Patients could receive double the intended dose, leading to serious adverse reactions.

• Possible side effects include hypersensitivity reactions, liver injury, somnolence, fatigue, dizziness, respiratory depression, coma, and hematological toxicity.

• High-risk patients include those receiving levetiracetam via rapid IV infusion for conditions like status epilepticus.

Distribution Details

• Affected batch distributed nationwide between November 4, 2024, and November 6, 2024.

• Distributed to wholesalers across the US.

Statements from Leaders or Officials
Dr Reddy's issued a public notice stating:
"Wholesalers, distributors, hospitals, and pharmacies are advised to immediately stop use and quarantine the affected product for return or replacement. The recall is being conducted with the knowledge of the US FDA."Dr Reddy's has not yet received reports of adverse events but emphasizes caution. Distributors are instructed to notify all downstream customers to ensure the recalled batch is removed from circulation to prevent any health hazards. This proactive step reflects the company’s commitment to patient safety and regulatory compliance.