FDA recall D-0630-2020

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-12-06

Report date

2019-12-25

Termination date

2020-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0630-2020