Drug product
CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.
D-464-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,819 tablets
- Official record key
drug-enforcement:D-464-2014
Official wording
Reason: Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014.
Code information: CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units has the following codes: Pedigree: W002610, EXP: 6/4/2014; Pedigree: AD54576_1, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup