Drug product
ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679099001
D-693-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-693-2014
Official wording
Reason: Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.
Code information: ZONISAMIDE Capsule, 100 mg has the following code Pedigree: W003786, EXP: 6/27/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled