Class II
Terminated
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
This recall has been terminated (originally issued February 12, 2014).
- Recall Initiated
- August 23, 2013
- Posted
- February 12, 2014
- Recall Number
- D-1062-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3764 cups
- Firm Location
- Nashville, TN, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14
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