Drug product
ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003
D-499-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Capsules
- Official record key
drug-enforcement:D-499-2014
Official wording
Reason: Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.
Code information: ITRACONAZOLE, Capsule, 100 mg has the following code Pedigree: AD54549_10, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled