Lannett Company, Inc. Recalls Levetiracetam Oral Solution

Date: 01/06/20

On December 20, 2019, the U.S. Food and Drug Administration (FDA) announced that Lannett Company, Inc. was recalling Levetiracetam Oral Solution to the consumer level due to contamination with Bacillus subtilis.

The FDA press release states the following:

Lannett Company, Inc. is voluntary recalling two lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product. Bacillus subtilis is ubiquitous in the environment and although the pathogenic potential has been described as low, serious systemic infections have been reported. 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.

Please immediately check your medical supplies, quarantine any drug products impacted, and do not administer them. The lot numbers associated with Lannett’s recalled products are as follows: Levetiracetam Oral Solution, 100mg/mL (lots 2190A and 2191A, expiration date 07/2021, NDC 54838-0548-80).

Review the FDA’s full press release

For questions or concerns, please reach out to Envolve Pharmacy Solutions’ Pharmacy Department by calling 1.800.782.2221.