Drugmaker Dr. Reddy’s Laboratories is recalling one batch of Levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level in the U.S. due to mislabelling.
The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminium overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, the company said on Thursday.
Both are indicated for adjunct therapy in adults with partial onset seizures; myoclonic seizures in patients with juvenile myoclonic epilepsy; and primary generalised tonic-clonic seizures. Patients administered the mislabelled product will likely experience adverse events.
Since the infusion bag is labelled as 500 mg/100 mL but 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, haematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression and coma.
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 said has not received any reports of adverse events related to the recall. The batch concerned was distributed to wholesalers in the U.S. between November 4 and 6, 2024.
This recall is being executed with the knowledge of the U.S. Food and Drug Administration (U.S. FDA), the company said.
Published – March 13, 2025 07:18 pm IST
