Levetiracetam Oral Solution Recalled Due to Microbial Contamination

US Food and Drug Administration

Lannett Company has issued a voluntary nationwide recall of 2 lots of its levetiracetam oral solution 100 mg/mL due to contamination with Bacillus subtilis. The contamination was discovered during an evaluation of a raw material used to manufacture the drug.

While Bacillus subtilis is described as a low-risk pathogen, serious systemic infections have been reported, dependent upon the degree of microbial contamination, dose, duration of treatment, and a person’s health history. There have so far been no reports of adverse events related to this recall.

Levetiracetam is FDA-approved for the treatment of partial-onset seizures in patients aged 1 month and older, for myoclonic seizures in patients who are age 12 and older, and for primary generalized tonic-clonic seizures in patients 6 and older. Notably, the FDA recently updated the levetiracetam drug label, making a number of alterations to the antiepileptic drug's prescribing information. Most notably, the agency made a revision to the warnings for withdrawal seizures and adverse reactions.

The 2 affected lots are:

• Levetiracetam oral solution 100 mg/mL NDC: 54838-548-80 Lot Number: 2190A Expiration: 07/2021
• Levetiracetam oral solution 100 mg/mL NDC: 54838-548-80 Lot Number: 2191A Expiration: 07/2021

“Lannett is notifying its distributors and customers via email and via the Lannett website and is arranging for return of all recalled products,” according to the company’s announcement.

Wholesalers or distributors, as well as patients, should contact Inmar or their pharmacy to return any remaining product that is included in the recalled lot numbers. Any adverse reactions or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

REFERENCE

Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination [news release]. Lannett Company, Inc. December 18, 2019. fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-levetiracetam-oral-solution-100mgml-due-microbial. Accessed October 20, 2019.