Drug product
FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578
D-568-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-568-2014
Official wording
Reason: Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014.
Code information: FEXOFENADINE HCL Tablet, 60 mg has the following codes Pedigree: W003020, EXP: 6/12/2014; Pedigree: AD60240_30, EXP: 5/22/2014; Pedigree: AD46257_50, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled