Drug product
prednisoLONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 16477050501
D-513-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-513-2014
Official wording
Reason: Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013.
Code information: prednisoLONE, Tablet, 5 mg has the following code Pedigree: W003627, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled