Drug product
Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
D-1589-2014
Product summary
- Event
- Event 68779
- Status
- Terminated
- Classification
- Class I
- Quantity
- 137,300 tablets
- Official record key
drug-enforcement:D-1589-2014
Official wording
Reason: Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Code information: Lot #142588, Exp 01/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up