Drug product
tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
D-620-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 299 Tablets
- Official record key
drug-enforcement:D-620-2014
Official wording
Reason: Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.
Code information: tiZANidine HCl, Tablet, 1 mg (1/2 of 2 mg) has the following code Pedigree: AD60272_52, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled