Drug product
NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762100401
D-644-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-644-2014
Official wording
Reason: Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014.
Code information: NIFEdipine, Capsule, 10 mg has the following code Pedigree: AD52778_55, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled