Drug product
TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722053001
D-545-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-545-2014
Official wording
Reason: Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001, Pedigree: AD25264_7, EXP: 5/3/2014.
Code information: TORSEMIDE Tablet, 10 mg has the following code Pedigree: AD25264_13, EXP: 5/3/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled