Company issues voluntary recall of Levetiracetam Oral Solution 100mg/mL

Company issues voluntary recall of Levetiracetam Oral Solution 100mg/mL
Levetiracetam is used to treat partial-onset seizures (Source: Lannett Company Inc.)

(KFVS) - Lannett Company, Inc. announced a voluntary recall of Levetiracetam Oral Solution, 100mg/mL on Dec. 18.

The recall includes two lots of the solution. It is due to contamination with Bacillus subtilis.

Company officials said it was discovered during an evaluation of the material used to make the product.

Levetiracetam is used to treat partial-onset seizures (Source: Lannett Company Inc.)
Levetiracetam is used to treat partial-onset seizures (Source: Lannett Company Inc.) (Source: Lannett Company Inc.)

The U.S. Food and Drug Administration said the contaminant is found regularly in the environment but serious infections have been reported after exposure to a large dose of the microbe.

Levetiracetam is used to treat partial-onset seizures in patients one-month and older. It can also be used for adjunctive therapy of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.

Levetiracetam can also be used with primary generalized tonic-clonic seizures in patients six years of age and older with idiopathic generalized epilepsy and is packaged in bottles of 16 fluid ounces.

Below are the affected lots:

Product NDC Lot Number Expiration Date

Levetiracetam Oral Solution 100mg/mL

54838-548-80

2190A

07/2021
Levetiracetam Oral Solution 100mg/mL 54838-548-80 2191A 07/2021

These were distributed nationwide in the Unites States.

Consumers with the product are asked to contact their pharmacy to return the product.

Company officials also said consumers should contact their physician or healthcare provider if they have experienced issued with the product.

Consumers with questions regarding this recall can contact Inmar by phone at (866) 255-4983, Monday-Friday, 9 a.m. - 5 p.m. (EST). Consumers with medical questions can contact the Lannett Medical Information Department at (844) 834-0530, Monday-Friday, 9 a.m. - 5 p.m. (EST).

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