Drug product
PARICALCITOL, Capsule, 1 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074431730.
D-809-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Capsules
- Official record key
drug-enforcement:D-809-2014
Official wording
Reason: Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 500 mg, NDC 60258014101, Pedigree: AD23082_19, EXP: 5/6/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002666, EXP: 6/5/2014.
Code information: PARICALCITOL, Capsule, 1 mcg has the following codes: Pedigree: AD23082_22, EXP: 5/6/2014; Pedigree: W002667, EXP: 6/5/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled