Drug product
SOLIFENACIN SUCCINATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51248015001
D-598-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-598-2014
Official wording
Reason: Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree: W003754, EXP: 6/26/2014.
Code information: SOLIFENACIN SUCCINATE, Tablet, 5 mg has the following code Pedigree: W003755, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled