FDA recall D-1062-2014

Central Shared Services dba Parallon · Class II · drug

Product

CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH

Reason for recall

CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.

Distribution

GA, KY, TN

Key facts

Status: Terminated
Initiation date: 2013-08-23
Report date: 2014-02-12
Termination date: 2014-02-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1062-2014