Drug product
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004025901.
D-771-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-771-2014
Official wording
Reason: Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52412_11, EXP: 5/17/2014.
Code information: MYCOPHENOLATE MOFETIL, Capsule, 250 mg has the following codes: Pedigree: AD49414_1, 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