Drug product
ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
D-631-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-631-2014
Official wording
Reason: Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.
Code information: ISOSORBIDE DINITRATE ER, Tablet, 40 mg has the following code Pedigree: AD23082_4, EXP: 5/3/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled