Drug product
NORTRIPTYLINE HCL, Capsule, 75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081301.
D-829-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Capsules
- Official record key
drug-enforcement:D-829-2014
Official wording
Reason: Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as one of the following drugs: guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD21790_58, EXP: 5/1/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141509, Pedigree: W003693, EXP: 4/30/2014.
Code information: NORTRIPTYLINE HCL, Capsule, 75 mg has the following codes: Pedigree: AD21790_73, EXP: 5/1/2014; Pedigree: W003694, EXP: 6/26/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled