Drug product
CHOLECALCIFEROL Capsule, 50000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 53191036201
D-610-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-610-2014
Official wording
Reason: Labeling: Label Mixup; CHOLECALCIFEROL Capsule, 50000 units may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD60272_64, EXP: 5/22/2014.
Code information: CHOLECALCIFEROL, Capsule, 50000 units has the following code Pedigree: AD60268_4, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled