Drug product
traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303
D-593-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,000 Tablets
- Official record key
drug-enforcement:D-593-2014
Official wording
Reason: Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP: 5/20/2014.
Code information: traZODone HCl, Tablet, 50 mg has the following code Pedigree: AD54475_7, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled