Drug product
MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.
D-855-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-855-2014
Official wording
Reason: Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62865_4, EXP: 5/23/2014.
Code information: MEXILETINE HCL, Capsule, 150 mg has the following codes: Pedigree: AD62865_7, EXP: 5/23/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled