Drug product
TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210201.
D-1006-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Capsules
- Official record key
drug-enforcement:D-1006-2014
Official wording
Reason: Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014.
Code information: TACROLIMUS, Capsule, 0.5 mg has the following codes: Pedigree: W003169, EXP: 6/13/2014; Pedigree: W003351, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled