Drug product
CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00005550924.
D-773-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Tablets
- Official record key
drug-enforcement:D-773-2014
Official wording
Reason: Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potentially mis-labeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: AD52387_1, EXP: 5/17/2014.
Code information: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units has the following codes: Pedigree: AD52993_1, EXP: 5/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup