Levetiracetam Oral Solution 100mg/mL recalled over sterility concerns

Recall date

December 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Lannett Company, Inc. recalls Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Phila…

Recall number

D-0630-2020

FDA classification

Class I

Brand / firm

Lannett Company, Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80