Dr Reddy’s recalls Levetiracetam Sodium Chloride Injection in US market

Dr Reddy’s Laboratories is recalling one batch of Levetiracetam in 0.75 percent Sodium Chloride Injection single-dose infusion bags to the consumer level, in the United States.  

“The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82 percent Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75 per cent Sodium Chloride Injection 1,000 mg/100 mL,” the company said in a release on Friday.

“Patients who are administered the mislabeled product will likely experience adverse events. 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,” the company said.

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.”

The Hyderabad-based Dr. Reddy’s had not received any reports of adverse events related to this recall, the company said.

 Levetiracetam Sodium Chloride Injections are indicated for adjunct therapy in adults with some types of seizures when oral administration is temporarily not feasible.