Drug product
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
D-523-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-523-2014
Official wording
Reason: Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet,
Code information: SERTRALINE HCL Tablet, 50 mg has the following codes Pedigree: AD70585_7, EXP: 5/29/2014; Pedigree: W003575, EXP: 6/24/2014; Pedigree: AD46426_1, EXP: 5/15/2014; Pedigree: AD30993_14, EXP: 5/9/2014; Pedigree: W003033, EXP: 6/12/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled