Drug product
COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764011907
D-696-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 Tablets
- Official record key
drug-enforcement:D-696-2014
Official wording
Reason: Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904
Code information: COLCHICINE Tablet, 0.6 mg has the following codes Pedigree: AD46419_1, EXP: 5/16/2014; Pedigree: AD52778_22, EXP: 5/20/2014; Pedigree: AD65457_1, EXP: 5/23/2014; Pedigree: W003612, EXP: 6/25/2014; Pedigree: W002961, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled