FDA recall D-523-2014

Aidapak Services, LLC · Class II · drug

Product

SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204

Reason for recall

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,

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-523-2014