Drug product
CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536342408.
D-929-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 Tablets
- Official record key
drug-enforcement:D-929-2014
Official wording
Reason: Labeling: Label Mixup: CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003460, EXP: 6/20/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD60240_1, EXP: 5/22/2014.
Code information: CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg has the following codes: Pedigree: W003461, EXP: 6/20/2014; Pedigree: AD60428_1, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled