Drug product
ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
D-1001-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-1001-2014
Official wording
Reason: Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.
Code information: ISOSORBIDE DINITRATE, Tablet, 5 mg has the following codes: Pedigree: W003474, EXP: 6/20/2014; Pedigree: AD56882_1, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled