Drug product
ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613
D-639-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Tablets
- Official record key
drug-enforcement:D-639-2014
Official wording
Reason: Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD464
Code information: ARIPiprazole, Tablet, 2 mg has the following codes Pedigree: AD21790_43, EXP: 5/1/2014; Pedigree: AD30140_25, EXP: 5/7/2014; Pedigree: AD46265_19, EXP: 5/15/2014; Pedigree: AD46414_1, EXP: 5/16/2014; Pedigree: W003004, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled