FDA-Drug2014-02-12Class II

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

Central Shared Services dba Parallon
Hazard

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

Sold states
GA, KY, TN
Affected count
3764 cups
Manufactured in
245B Great Circle Road, Nashville, TN, United States
Products
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH

Official notice

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

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