Drug product
PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009190
D-509-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 359 Tablets
- Official record key
drug-enforcement:D-509-2014
Official wording
Reason: Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213, Pedigree: AD23082_13, EXP: 11/1/2013; PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: W003682, EXP: 6/25/2014.
Code information: PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg has the following codes Pedigree: AD25264_10, EXP: 5/3/2014; Pedigree: W003683, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled