Drug product
ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
D-767-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Capsules
- Official record key
drug-enforcement:D-767-2014
Official wording
Reason: Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014.
Code information: ATOMOXETINE HCL, Capsule, 18 mg has the following codes: Pedigree: AD30140_16, EXP: 5/7/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup