Drug product
traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111044101
D-594-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-594-2014
Official wording
Reason: Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014.
Code information: traZODone HCl, Tablet, 150 mg has the following codes Pedigree: AD21858_7, EXP: 5/1/2014; Pedigree: W003245, EXP: 6/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled