Home / Recalls / Central Shared Services dba Parallon / D-1062-2014

D-1062-2014 Class II Terminated

Recalled by Central Shared Services dba Parallon — Nashville, TN

Recall Details

Product Type: Drugs
Report Date: February 12, 2014
Initiation Date: August 23, 2013
Termination Date: February 4, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3764 cups

Product Description

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 Pattern

GA, KY, TN

Code Information

600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14