Drug product
RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.
D-769-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-769-2014
Official wording
Reason: Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701; Pedigree: W002656, EXP: 6/4/2014.
Code information: RALOXIFENE HCL, Tablet, 60 mg has the following codes: Pedigree: W002644, EXP: 6/5/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup