Drug product
LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060
D-697-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Capsules
- Official record key
drug-enforcement:D-697-2014
Official wording
Reason: Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.
Code information: LUBIPROSTONE Capsule, 24 mcg has the following codes Pedigree: AD21790_46, EXP: 5/1/2014; Pedigree: AD21811_1, EXP: 5/1/2014; Pedigree: AD46312_1, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled