FDA recall D-0127-2018

Claris Lifesciences Inc · Class III · drug

Product

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249

Reason for recall

Superpotent

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-11-06
Report date: 2017-12-27
Termination date: 2020-04-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2018