December 20, 2019
Lannett Company, Inc., has issued a voluntary recall of two lots of Levetiracetam Oral Solution 100mg/mL due to contamination with Bacillus subtilis identified during evaluation of a raw material used to manufacture the product.
Bacillus subtilis is a bacterium regularly found in the environment. It generally presents a low risk of disease, but serious systemic infection is possible. According to the recall notice, the chance of infection is dependent on factors that include degree of microbial contamination, dose and duration of treatment with the affected product, and the nature of a patient’s medical conditions. Lannett had received no reports of adverse events as of the date of the recall.
Levetiracetam is used to treat certain types of seizures in pediatric and adult patients. If a patient experiences any adverse events that may be related to the use of the drug, they should contact their healthcare provider. Adverse events can also be reported to the FDA’s MedWatch program.
To return recalled product, consumers should contact the pharmacy from which it was dispensed. The affected lot numbers are 2190A and 2191A, both with expiry dates of 7/2021. Questions regarding the recall should be directed to Inmar at 1-866-255-4983. Medical questions can be directed to the Lannett Medical Information Department at 1-844-834-0530.
Additional information is available at the FDA’s website. Benecard’s Mail Order Pharmacy, Benecard Central Fill has not dispensed the recalled product.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.