Drug product
DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
D-766-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 Capsules
- Official record key
drug-enforcement:D-766-2014
Official wording
Reason: Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL
Code information: DULoxetine HCl DR, Capsule, 20 mg has the following codes: Pedigree: AD30140_31, EXP: 5/7/2014; Pedigree: AD54587_4, EXP: 5/21/2014; Pedigree: AD70585_16, EXP: 5/29/2014; Pedigree: W003506, EXP: 6/21/2014; Pedigree: AD60272_61, EXP: 5/22/2014; Pedigree: AD21790_49, EXP: 5/1/2014; Pedigree: W003005, EXP: 6/11/2014; Pedigree: W003486, EXP: 6/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup