Drug product
predniSONE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591544301.
D-976-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 603 Tablets
- Official record key
drug-enforcement:D-976-2014
Official wording
Reason: Labeling: Label Mixup:predniSONE, Tablet, 20 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD54587_7, EXP: 5/21/2014.
Code information: predniSONE, Tablet, 20 mg has the following codes: Pedigree: AD56879_5, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled