Drug product
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378225001.
D-904-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-904-2014
Official wording
Reason: Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg, NDC 16714058501, Pedigree: W003761, EXP: 6/26/2014.
Code information: MYCOPHENOLATE MOFETIL, Capsule, 250 mg has the following codes: Pedigree: W003763, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled