Drug product
MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004026001.
D-772-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-772-2014
Official wording
Reason: Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00004025901, Pedigree: AD49414_1, EXP: 5/17/2014.
Code information: MYCOPHENOLATE MOFETIL, Tablet, 500 mg has the following codes: Pedigree: AD49414_4, EXP: 5/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup