Drug Safety Alerts

Lannett Levetiracetam 100 mg/mL Consumer-Level Recall

12/18/2019

On December 18, 2019, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Levetiracetam 100 mg/mL Solution NDC # 54838-0548-80 manufactured by Lannett. This recall was issued due to contamination with Bacillus subtilis.  The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot numbers 2190A exp. 07/2021 and 2191A 07/2021.The affected lots went into distribution on August 15, 2019.

Patients have been instructed to call their prescribers immediately if they are using the affected recalled product so an alternative treatment plan can be established prior to discontinuation and return of the affected recalled product.

Bacillus subtilis is ubiquitous in the environment and although the pathogenic potential has been described as low, serious systemic infections have been reported. The likelihood of the health hazard depends on the degree of microbial contamination, the dose and duration of treatment, and the patient’s underlying conditions. It is possible that a severe infection may occur in immunocompromised patients. Lannett has not received any reports of adverse events related to this recall to date.

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month and older.  It is also indicated for adjunctive therapy of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.

CVS Caremark Response:

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

For more information about this recall, please contact Inmar at 1-866-255-4983, Monday through Friday, 9:00 a.m. to 5:00 p.m. (ET) or visit www.lannett.com.  You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.