FDA Drug recall D-523-2014
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
- FDA Drug
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204 by Aidapak Services, citing 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; guaiF….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-523-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-02 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aidapak Services |
| Distribution | AZ, CA, OR, WA |
Product
SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
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,
Identifiers
| code_info | SERTRALINE HCL Tablet, 50 mg has the following codes Pedigree: AD70585_7, EXP: 5/29/2014; Pedigree: W003575, EXP: 6…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-523-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.