Drug product
NEFAZODONE HCL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093102506.
D-831-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-831-2014
Official wording
Reason: Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 200 mg may have potentially been mislabeled as the following drug: NEFAZODONE HCL, Tablet, 150 mg, NDC 00093711306, Pedigree: AD46414_41, EXP: 5/16/2014.
Code information: NEFAZODONE HCL, Tablet, 200 mg has the following codes: Pedigree: AD46414_44, EXP: 5/16/2014
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled