Drug product
CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760
D-488-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,998 Tablets
- Official record key
drug-enforcement:D-488-2014
Official wording
Reason: Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175
Code information: CHOLECALCIFEROL, Tablet, 2000 units has the following codes Pedigree: AD46312_37, EXP: 5/16/2014; Pedigree: AD65311_1, EXP: 5/24/2014; Pedigree: W003539, EXP: 6/21/2014; Pedigree: W003744, EXP: 6/26/2014; Pedigree: AD54586_10, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled