Drug Safety Alerts

Levetiracetam Injection Voluntary Recall

11/19/2021

On November 19, 2021, Sagent Pharmaceuticals, Inc. issued a user-level recall of Levetiracetam Injection 500mg/5 mL (100mg/1 mL) NDC # 25021-0780-05. This recall was issued due to a container closure integrity issue found in reserve sample vials that may result in a non-sterile product.

This recall affects lot numbers B0G85VB exp. 06/2022, B0K88VA exp. 09/2022. B0K89VA exp. 09/2022 & B1G194A exp. 06/2023.

Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening. Sagent has advised that as of the date of recall, it has not received reports of any product complaints or adverse events associated with this issue. Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial.

Consumers should contact their physician for medical advice. Your doctor is familiar with your medical history and can suggest the best treatment option for you.

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

For more information about the recall of Levetiracetam Injection 500mg/5 mL (100mg/1 mL), please call Sagent Customer Call Center, toll-free at 1-866-625-1618. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.