Dr. Reddy's Labs Recalls Levetiracetam In Sodium Chloride Injection

(RTTNews) - Dr. Reddy's Laboratories Ltd. is recalling select Levetiracetam in Sodium Chloride Injection in the United States citing mislabeling of infusion bag, according to the U.S. Food and Drug Administration.

The recall involves 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.

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.

Both Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL are indicated for adjunct therapy in adults with select seizure types when oral administration is temporarily not feasible.

When administered the mislabeled product, the patient could receive double the dose of intravenous levetiracetam than intended as the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose. Such patients are likely to experience adverse events, leading to immediate and serious side effects. These include hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma.

The FDA noted that 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.

However, Dr. Reddy's has not received any reports of adverse events related to the recalled product so far.

The recall involves Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton.

The mislabelled bags come with NDC numbers 43598-635-52 and 43598-636-52, with Lot Number A1540076 and Expiration Date of 08/2026. The carton holds NDC number 43598-636-10. The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers.

Dr. Reddy's is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the impacted lot are asked to stop use and distribution and quarantine the product immediately for return/replacement.

Dr. Reddy's last year had called back six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level, due to powder discoloration in some packets leading to decreased potency.

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