Dr. Reddy’s Laboratories is continuing its voluntary recall of 1 lot of Levetiracetam in 0.54% Sodium Chloride Injection, 1500mg/100mL (15mg/mL) single-dose infusion bag due to mislabeling.
Levetiracetam Injection, an antiepileptic, is indicated as adjunct therapy in patients aged ≥16 years with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures, when oral administration is temporarily not feasible.
The recall of Lot# ABD807 (Gland Pharmaceuticals; Exp 05/2020) was initially announced in October 2018 following a product complaint regarding mislabeling. The pre-printed text on the infusion bag (primary container) for the lot states the product information as Levetiracetam in 0.75% Sodium Chloride Injection 1000mg/100mL. The label on the external foil pouch, however, states the product information as Levetiracetam 0.54% Sodium Chloride Injection (1500mg/100mL).
The affected lot was distributed between August 14, 2018 and September 5, 2018. Any wholesaler, distributor, hospital or pharmacy with existing inventory of the recalled lot should discontinue use and quarantine the product immediately for return or replacement. To date, there have not been any reports of adverse events related to this recall.
For more information call (800) 967-5952 or visit DrReddys.com.