Drug product
ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310
D-680-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-680-2014
Official wording
Reason: Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.
Code information: ESZOPICLONE, Tablet, 3 mg has the following code Pedigree: W002765, EXP: 6/6/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled