Lannett Co. Inc. initiated a voluntary recall of two lots of its Levetiracetam Oral Solution due to microbial contamination.
Levetiracetam is indicated for treating partial-onset seizures in patients 1 month and older. It is also used as an add-on therapy in the treatment of different epilepsy patients, including patients aged 12 years and above with juvenile myoclonic epilepsy and patients aged 6 years and above with idiopathic generalized epilepsy.
Epilepsy is a central nervous system disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness.
The company issued the recall of the drug Dec. 18 after identifying the contamination of Bacillus subtilis during the evaluation of raw materials used to manufacture the medicine. Bacillus subtilis is bacteria that can lead to serious systematic infections, some of which have been reported by the company.
Previously in October, the Philadelphia-based company recalled all lots of its ranitidine syrup due to high levels of a potentially cancer-causing substance called N-Nitrosodimethylamine.