Drug product
CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460
D-486-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,399 Tablets
- Official record key
drug-enforcement:D-486-2014
Official wording
Reason: Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601
Code information: CHOLECALCIFEROL, Tablet, 1000 units has the following codes Pedigree: W003464, EXP: 6/20/2014; Pedigree: AD33897_37, EXP: 5/9/2014; Pedigree: W002779, EXP: 6/6/2014; Pedigree: W003626, EXP: 6/25/2014; Pedigree: W003827, EXP: 6/27/2014; Pedigree: AD33897_34, EXP: 5/9/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled