Drug product
PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430
D-507-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-507-2014
Official wording
Reason: Labeling: Label Mixup; PARoxetine HCl, Tablet, 10 mg may be potentially mislabeled as PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 62175018046, Pedigree: AD52778_64, EXP: 5/20/2014.
Code information: PARoxetine HCl, Tablet, 10 mg has the following code Pedigree: AD52778_67, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled