Dr. Reddy’s recalls mislabelled Levetiracetam injection in the US; patients likely to experience 'adverse' events

Dr. Reddy’s Laboratories is recalling Lot No: A1540076 of Levetiracetam 0.75% Sodium Chloride Injection, 1,000 mg/100 mL, single-dose infusion bags in the United States. The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Patients who are administered the mislabeled product will likely experience adverse events, as per the risk statement issued by the company.
Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended which could lead to immediate and serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma, as per the company.

Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr. Reddy’s has not received any reports of adverse events related to this recall.

Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy