Drug product
NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030301
D-577-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-577-2014
Official wording
Reason: Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.
Code information: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg has the following code Pedigree: AD52778_58, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled