Drug product
MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781206701.
D-1005-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Capsules
- Official record key
drug-enforcement:D-1005-2014
Official wording
Reason: Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: W003213, EXP: 6/14/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011010, Pedigree: AD65317_1, EXP: 5/24/2014.
Code information: MYCOPHENOLATE MOFETIL, Capsule, 250 mg has the following codes: Pedigree: W003215, EXP: 6/14/2014; Pedigree: AD65457_7, EXP: 5/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled