Drug product
FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 41167412003
D-554-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-554-2014
Official wording
Reason: Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.
Code information: FEXOFENADINE HCL, Tablet, 180 mg has the following code Pedigree: AD62834_1, EXP: 5/23/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled