Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection

Antiepilectic Drug Given as Adjunct Therapy in Adults With Certain Seizure Types

Dr. Reddy’s Laboratories, Inc. is continuing its voluntary nationwide recall of lot ABD807 of levetiracetram in 0.54% sodium chloride injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to hospitals in the U.S.

The recall was originally initiated due to a product complaint received for mislabeling. The text content on the infusion bag indicates the product information as Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL). The label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1,500 mg/100 mL). There are no reports of adverse events related to this recall to date.

Levetiracetam injection is an antiepileptic drug indicated for adjunct therapy in adults (more than 16 years of age) with certain seizure types when oral administration is temporarily not feasible: partial onset seizures, myoclonic seizures inpatients with juvenile myoclonic epilepsy, and primary generalized tonic–clonic seizures.

Patients who may have received the mislabeled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression, and coma related to overdose.

The batch was distributed in the U.S. between August 14, 2018 and September 5, 2018. Information about the recalled batch is available on the FDA site.

Source: FDA, February 5, 2019