Drug product
traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043301
D-592-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 Tablets
- Official record key
drug-enforcement:D-592-2014
Official wording
Reason: Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014.
Code information: traZODone HCl, Tablet, 50 mg has the following codes Pedigree: AD37088_4, EXP: 5/9/2014; Pedigree: AD54562_1, EXP: 5/20/2014; Pedigree: AD39611_4, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled