Drug product
tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289
D-627-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 299 Tablets
- Official record key
drug-enforcement:D-627-2014
Official wording
Reason: Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014.
Code information: tiZANidine HCL, Tablet, 2 mg has the following codes Pedigree: AD70700_10, EXP: 5/29/2014; Pedigree: W003750, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled