Drug product
QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313001
D-664-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 Tablets
- Official record key
drug-enforcement:D-664-2014
Official wording
Reason: Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree: AD32325_1, EXP: 5/9/2014; ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: W003094, EXP: 6/13/2014.
Code information: QUEtiapine FUMARATE, Tablet, 25 mg has the following codes Pedigree: AD33897_25, EXP: 5/9/2014; Pedigree: W003099, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled