Drug product
FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130
D-728-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 Tablets
- Official record key
drug-enforcement:D-728-2014
Official wording
Reason: Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014.
Code information: FLUCONAZOLE, Tablet, 50 mg has the following code Pedigree: W003066, EXP: 6/12/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled