Prescription medicine used mainly for kids recalled after contamination found
Contamination in an ingredient caused Lannett Company, Inc. to recall two lots of Levetiracetam Oral Solution, 100mg/mL strength in 16-ounce bottles.
Levetiracetam is used to treat seizures, mostly in children.
“The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product,” the Lannett-written, FDA-posted recall notice states. “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.”
This hasn’t happened yet, thus the precautionary recall of lot Nos. 2190A and 2191A, both with an 07/2021 expiration date. The NDC No. is 54838-548-80.
Anyone with medical questions about this can call Lannett’s Medical Information Department, 844-834-0530, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
Anyone with questions about returning recalled medicine can call Inmar, 866-255-4983, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
Bad reactions to this or any other medication can be reported to the FDA by clicking here.
This story was originally published December 21, 2019 at 2:13 PM.
