Drug product
RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50458057930
D-596-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-596-2014
Official wording
Reason: Labeling: Label Mixup; RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: W002619, EXP: 6/4/2014.
Code information: RIVAROXABAN, Tablet, 20 mg has the following code Pedigree: W002620, EXP: 6/4/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled