Drug product
clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00093083201.
D-830-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-830-2014
Official wording
Reason: Labeling: Label Mixup: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: ADWA00002136, EXP: 5/31/2014.
Code information: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) has the following codes: Pedigree: AD73518_1, EXP: 5/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled