Dr. Reddy's issues a nationwide recall of Levetiracetam drug in the US; check details

It is being recalled, as 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 batch was distributed nationwide in the US between November 4, 2024, and November 6, 2024, to wholesalers.

The drugmaker, in a statement to the exchanges, explained: “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 a 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.”

Among the side effects, it has mentioned 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 has not received any reports of adverse events related to this recall,” it further mentioned in its statement.

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 (5 mg/mL), are both indicated for adjunct therapy in adults with the following seizure types: partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy and primary generalised tonic-clonic seizures.

Dr. Reddy’s Laboratories, Inc. is notifying its distributors and customers to arrange for the return of any recalled product.

The announcement came post the Indian market hours. On Thursday, shares of the drugmaker settled at ₹1,106.35 apiece, rising 0.11% on the National Stock Exchange.