Drug product
CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001
D-701-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 509 Tablets
- Official record key
drug-enforcement:D-701-2014
Official wording
Reason: Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014; VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014.
Code information: CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg has the following codes Pedigree: W002581, EXP: 6/3/2014; Pedigree: AD32345_1, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled