D-523-2014 Class II Terminated

Recalled by Aidapak Services, LLC — Vancouver, WA

Recall Details

Product Type
Drugs
Report Date
January 22, 2014
Initiation Date
July 2, 2013
Termination Date
February 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 Tablets

Product Description

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 Pattern

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

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.