FDA recall D-1215-2018

Product

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

Reason for recall

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-09-25

Report date

2018-10-03

Termination date

2020-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1215-2018