Dr Reddy’s Laboratories has announced a nationwide recall of one batch of Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL) in the US due to a labeling error on the infusion bag.
The recall, which applies to lot number A1540076, was initiated after the infusion bag was incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection (500 mg/100 mL), while the aluminum overwrap correctly identified the product.
The mislabeling poses a significant health risk, as patients receiving the drug could inadvertently be administered double the intended dose of Levetiracetam, leading to severe adverse effects.
The potential risks include hypersensitivity reactions, liver injury, hematological toxicity, drowsiness, dizziness, respiratory depression, and, in extreme cases, coma. Dr Reddy’s stated that it has not yet received any reports of adverse events linked to the recall.
Levetiracetam is prescribed as an adjunct therapy for partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures when oral administration is not feasible. The affected batch was distributed nationwide in the US between November 4 and November 6, 2024, to wholesalers.
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Dr Reddy’s has urged distributors, hospitals, and pharmacies to stop using and distributing the affected batch immediately and quarantine the product for return. The recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).
Ahead of the announcement, shares of Dr Reddy’s Laboratories closed at ₹1,107.85, up 0.24% on the BSE.
