Drug product
PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690
D-510-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-510-2014
Official wording
Reason: Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: W003694, EXP: 6/26/2014.
Code information: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg has the following code Pedigree: W003695, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabel