Sagent Pharmaceuticals, Inc. is voluntarily recalling 4 lots of Levetiracetam Injection, USP 500mg per 5mL, to the user level due to a lack of container closure integrity found in reserve sample vials that may result in a nonsterile product.
Levetiracetam Injection, an anticonvulsant, is indicated for the treatment of partial-onset seizures in patients 1 month of age and older; for adjunctive treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy; and for adjunctive treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. It is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
The recalled lots of Levetiracetam Injection 500mg per 5mL; NDC Number 25021-780-05, were distributed nationwide from March 2021 to November 2021 and include the following:
- Lot number B0G85VB; expiration date: June 2022; distribution dates: May 2021 to August 2021;
- Lot number B0K88VA; expiration date: September 2022; distribution dates: March 2021 to November 2021;
- Lot number B0K89VA; expiration date: September 2022; distribution dates: August 2021 to November 2021;
- Lot number B1G194A; expiration date: June 2023; distribution dates: October 2021.
Intravenous administration of recalled products that are not sterile may result in serious, life-threatening systemic infections. To date, the Company has not received any reports of product complaints or adverse events related to this recall.
Consumers or health care workers with any questions regarding this recall should contact the customer call center at (866) 625-1618.
Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.
Sagent Pharmaceuticals, Inc. issues voluntary nationwide recall of Levetiracetam Injection, USP due to lack of sterility assurance. News release. Sagent Pharmaceuticals, Inc. Accessed November 22, 2021. https://www.prnewswire.com/news-releases/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-of-levetiracetam-injection-usp-due-to-lack-of-sterility-assurance-301429330.html.
Source: Medical Bag https://www.medicalbag.com/home/news/sterility-issue-prompts-recall-of-injectable-antiepileptic-drug/