Drug product
MEXILETINE HCL, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093874001.
D-856-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-856-2014
Official wording
Reason: Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as the following drug: ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD25264_1, EXP: 5/3/2014.
Code information: MEXILETINE HCL, Capsule, 200 mg has the following codes: Pedigree: AD25264_7, EXP: 5/3/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled