Drug product
COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65597070118
D-714-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Tablets
- Official record key
drug-enforcement:D-714-2014
Official wording
Reason: Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: AD46265_31, EXP: 5/15/2014.
Code information: COLESEVELAM HCL Tablet, 625 mg has the following code Pedigree: AD46426_19, EXP: 5/15/2014
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled