Drug product
NORTRIPTYLINE HCL, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081001.
D-827-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-827-2014
Official wording
Reason: Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 10 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD70585_1, EXP: 5/29/2014.
Code information: NORTRIPTYLINE HCL, Capsule, 10 mg has the following codes: Pedigree: AD70585_4, EXP: 5/29/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled