Drug product
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
D-1062-2014
Product summary
- Event
- Event 66313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3764 cups
- Official record key
drug-enforcement:D-1062-2014
Official wording
Reason: CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Code information: 600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14
Distribution pattern: GA, KY, TN
Derived failure modes
-
Manufacturing or process control
CGMP Deviation