Drug product
QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 47335090288
D-575-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-575-2014
Official wording
Reason: Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598, Pedigree: AD22845_4, EXP: 5/2/2014.
Code information: QUETIAPINE FUMARATE, Tablet, 12.5 mg (1/2 of 25 mg) has the following code Pedigree: AD21790_79, EXP: 5/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled