Drug Safety Alerts

Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL Class I Recall

02/20/2019

On February 20, 2019, the United Sates Food and Drug Administration (FDA) issued a notice regarding a Class I recall of levetiracetam in 0.54 % sodium chloride injection 1,500/mg/100mL. This recall was issued due to a labeling error. The pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as levetiracetam in 0.75% sodium chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as levetiracetam in 0.54% sodium chloride injection (1,500/100 mL).

A complete list of the affected products and lot numbers is provided here:

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

Levetiracetam injection is an antiepileptic drug indicated for adjunct therapy in adults (more than 16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures inpatients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Dr. Reddy’s Medical Information at 1-888-DRL-DRUG (1-888-375-3784). You may also contact the FDA consumer inquiry line 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.accessdata.fda.gov.