Drug product
NORTRIPTYLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081201.
D-828-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Capsules
- Official record key
drug-enforcement:D-828-2014
Official wording
Reason: Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as one of the following drugs: ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: AD21811_10, EXP: 5/2/2014; LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 42794001802, Pedigree: AD46414_38, EXP: 5/16/2014.
Code information: NORTRIPTYLINE HCL, Capsule, 50 mg has the following codes: Pedigree: AD21790_70, EXP: 5/1/2014; Pedigree: AD46414_47, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled