Drug product
FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230
D-729-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-729-2014
Official wording
Reason: Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003086, EXP: 6/12/2014.
Code information: FLUCONAZOLE, Tablet, 100 mg has the following code Pedigree: W003064, EXP: 6/12/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled