Drug product
PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058501
D-521-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-521-2014
Official wording
Reason: Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003704, EXP: 6/26/2014.
Code information: PRAMIPEXOLE DI-HCL Tablet, 0.25 mg has the following code Pedigree: W003761, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled