Dr. Reddy's Levetiracetam in Sodium Chloride Injection recalled due to Mislabeling, USA

United States

Dr. Reddy's Laboratories Ltd., is recalling one Batch/Lot No: A1540076 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 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.

Risk Statement: 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. 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.

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 in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:

- Partial onset seizures
- Myoclonic seizures in patients with juvenile myoclonic epilepsy
- Primary generalized tonic-clonic seizures

Each product is packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton. Identification information such as lot number, expiration date and NDC is presented in the table below. The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers.

DESCRIPTION OF MISLABELLED BAGS BEING RECALLED:
- NDC Numbers: 43598-635-52
- Product Overlap: Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL
- Product Infusion Bag: Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag.
- Lot Number: A1540076
- Expiration Date: 08/2026

- NDC Numbers: 43598-636-52
- Product Overlap: Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL
- Product Infusion Bag: Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag
- Lot Number: A1540076
- Expiration Date: 08/2026

DESCRIPTION OF CARTON BEING RECALLED:
- Product Name: Levetiracetam in 0.75% Sodium Chloride Injection
- Strength & Packaging: 1,000 mg/100 mL, 10 single-dose bags per carton
- NDC Number: 43598-636-10
- Lot Number: A1540076
- Expiration Date: 08/2026

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-nationwide-recall-levetiracetam-075-sodium-chloride-injection-1000-mg100-ml-us-due