FDA recall D-1034-2018

Product

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.

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

2018-08-01

Report date

2018-08-15

Termination date

2020-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1034-2018