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FDAFDA · Food and drugs·Recall number D-1062-2014

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

Published February 12, 2014 · Recall initiated: August 23, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Central Shared Services dba Parallon
Distributor
GA, KY, TN
Lot
600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14
Risk classification
Class II
Area (FDA)
drug
Country
United States

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