Drug product
ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000913
D-640-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 Tablets
- Official record key
drug-enforcement:D-640-2014
Official wording
Reason: Labeling:Label Mixup; ARIPiprazole, Tablet, 15 mg may be potentially mislabeled as ATOMOXETINE HCL, Capsule, 40 mg, NDC 00002322930, Pedigree: AD21790_82, EXP: 5/1/2014; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, NDC 13668009190, Pedigree: AD25264_10, EXP: 5/3/2014.
Code information: ARIPiprazole Tablet, 15 mg has the following codes Pedigree: AD21965_1, EXP: 5/1/2014; Pedigree: AD28322_1, EXP: 5/6/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled